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ROCKVILLIE, Md. and SUZHOU, China, May 10, 2023 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announced that the phase 2 clinical study of higher dose (9 mg) mazdutide (Innovent R&D Code: IBI362) in Chinese adults with obesity achieved the 24-week primary endpoint.

This is a randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of mazdutide 9 mg in Chinese subjects with obesity [body mass index (BMI) 30.0 kg/m2]. A total of 80 subjects were enrolled (mean baseline weight 96.9 kg, mean height 168.0 cm, mean BMI 34.3 kg/m2) and randomized in a 3:1 ratio to mazdutide 9 mg group or placebo group to receive treatment once a week for 24 weeks. The primary endpoint is the percent change in body weight from baseline versus placebo after 24 weeks of treatment. The study will also extend treatment to 48 weeks.

The results showed that mazdutide 9 mg demonstrated superior body weight loss versus placebo in Chinese subjects with obesity. After 24 weeks of treatment, the treatment difference of the mean percent change in body weight from baseline versus placebo was -15.4%95%CI: -18.8%, -11.9%, P<0.0001; The treatment difference of the mean change in body weight from baseline versus placebo was -14.7 kg95%CI-17.9 kg, -11.5 kgP<0.0001. Meanwhile, 81.7%65.0%31.7% and 21.7% of the subjects in the mazdutide 9 mg group achieved 5% or more,10% or more, 15% or more and 20% or more weight loss from baseline, respectively, while no subject in the placebo group lost 5% or more of body weight from baseline.

In terms of safety, the overall tolerability and safety of the mazdutide 9 mg was favorable. The drop-out rate of the mazdutide group was lower than that of the placebo group. No subject in the mazdutide group discontinued treatment due to adverse events. No serious adverse events occurred. Except for COVID-19 infection, the most commonly-reported adverse events were gastrointestinal-related adverse events, most of which were mild or moderate and transient.

The study is still in progress, and the data of other secondary and exploratory endpoints of the study will be analyzed and disclosed after the end of the study.

Professor Linong Ji, the leading principal investigator of the study, Peking University People's Hospital, stated,"The overweight and obese population in China has continued to increase in recent years. There are about 160 million obese people across China (BMI 28.0 kg/m2), of which approximately 10 million are with moderate and severe obesity (BMI 32.5 kg/m2). The risk of cardiovascular and cerebrovascular diseases for these patients is extremely high, and the quality of daily life and mental health of these patients are significantly affected. Compared with the general obese population, moderately- to severely- obese patients urgently need effective and safe weight loss options. At present, metabolic surgery is the main treatment for people with a BMI 32.5 kg/m2, other treatment options are limited. Despite the obvious efficacy of surgical weight loss, it is only used in a small number of patients for many reasons. In recent years, the development of GLP-1 receptor agonists, especially a new generation of dual-target agonists, has brought prospects for weight loss drugs. However, there are few clinical studies on GLP-1 receptor agonists in patients with moderate to severe obesity in the world, especially in the Chinese population.

I am pleased to see the weight loss efficacy of mazdutide 9 mg has been further improved versus mazdutide 6 mg while showing good tolerability and safety. The observed efficacy of mazdutide 9 mg after 24 weeks of treatment is approaching that of metabolic surgery, which suggests the potential of mazdutide to become a more ideal therapeutic drug for patients with moderate to severe obesity. This study also fills the gap in the clinical research of drug treatment of patients with severe obesity in Chinese and even East Asian populations. I am hopeful that mazdutide 9 mg will also show satisfactory results in future phase 3 studies."

Dr. Lei Qian, Vice President of Clinical Development at Innovent,stated, " Mazdutide 9 mg achieved the primary endpoint in the phase 2 study of subjects with moderate to severe obesity in China, demonstrated a superior weight loss efficacy to placebo after 24 weeks of treatment while showing good tolerability and safety, which is an important step in the overall indication development strategy and lifecycle management of mazdutide. From a global perspective, weight loss treatments for patients with moderate to severe obesity are extremely limited. Single-target GLP-1 drugs have limited efficacy in this population and can hardly achieve 15% placebo-adjusted weight loss even with one year's treatment. However, the mazdutide 9mg regimen gave encouraging efficacy of 15.4% (14.7kg) placebo-adjusted weigh loss only after 24 weeks, in a population with baseline average BMI of 34.3 kg/m2, suggesting it will be effective in the population with greater unmet need for effective therapy. These results are comparable to the most effective multi-target GLP-1 receptor agonist drugs and even bariatric surgery, and a trend of continuous decline of body weight was observed at Week 24 in the study. The study is still in progress and will continue to evaluate the efficacy and safety after 48 weeks of treatment. I am confident that that longer treatment will bring more weight loss efficacy. In addition, we will advance the phase 3 clinical study of mazdutide 9 mg in due course, and strive to provide a drug treatment option that can potentially offer a treatment option where today the only highly effective option is bariatric surgery."

About Obesity

China has the largest overweight and obese population in the world, with the obesity rate likely to increase. Obesity can lead to a range of complications or related diseases that impact life expectancy and deteriorate the quality of life. In more severely obese patients, the incidence and mortality of cardiovascular disease, diabetes, and certain tumors increase significantly. Obesity is a chronic disease that requires long-term management, and there is a lack of long-term effective and safe treatments. Lifestyle intervention is the first choice and basic treatment for patients with overweight or obesity. However, a considerable percentage of patients fail to achieve the desired weight loss goal upon lifestyle intervention and may require pharmacological intervention. Traditional pharmacological therapies have been of limited efficacy and safety issues, highlighting the unmet need for more effective and safe therapies.

About Mazdutide

Innovent entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, in addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes and liver fat content, as well as improving insulin sensitivity, bringing multiple metabolic benefits. Currently, three key phase 3 studies of mazdutide 4 mg and 6 mg in Chinese patients with overweight or obesity (GLORY-1) and type 2 diabetic (DREAM-1 and DREAM-2) subjects are underway. The Phase 2 clinical study of mazdutide 9 mg in Chinese patients with obesity is in progress.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT (sintilimab injection), BYVASDA (bevacizumab injection), SULINNO (adalimumab injection), HALPRYZA (rituximab injection), Pemazyre (pemigatinib oral inhibitor), olverembatinibBCR ABL TKI,Cyramza (ramucirumab) and Retsevmo (selpercatinib). An additional 3 assets are under NMPA NDA review, 6 assets are in Phase III or pivotal clinical trials, and 18 more molecules are in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into 28 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.

Note:

TYVYT (sintilimab injection) is not an approved product in the United States.

BYVASDA (bevacizumab biosimilar injection), SULINNO, and HALPRYZA (rituximab biosimilar injection) are not approved products in the United States.

TYVYT (sintilimab injection, Innovent)

BYVASDA (bevacizumab biosimilar injection, Innovent)

HALPRYZA (rituximab biosimilar injection, Innovent)

SULINNO (adalimumab biosimilar injection, Innovent)

Pemazyre (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA (ramucirumab, Eli Lilly). Cyramza was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo (selpercatinib, Eli Lilly). Retsevmo was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer:

1. This indication is still under clinical study, which hasn't been approved in China.

2. Innovent does not recommend any off-label usage.

Forward-looking statement

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

SOURCE Innovent Biologics

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Innovent Announces Phase 2 Clinical Study of Higher dose 9 mg ... - PR Newswire

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A new face may soon introduce itself to treatment algorithms for chronic weight management, as topline data from a phase 2 trial suggests use of a dual glucagon/GLP-1 receptor agonist, called BI 456906, could help patients lose up to 14.9% of their body weight after 46 weeks in people with obesity or overweight without type 2 diabetes.

The excitement surrounding development in the world of obesity management has been at a fever pitch since the presentation of SURMOUNT-1 results at the American Diabetes Association (ADA) 2022 Scientific Sessions.2 Now, fast-forward to May 10, 2023, and Boehringer Ingelheim and Zealand Pharma are hopeful to drum up the same fervor as they announced plans to present the results of their phase 2 dose-finding trial for BI 456906 at the upcoming ADA 2023 Scientific Sessions in less than 2 months.1

Obesity is one of many cardio-renal-metabolic diseases, which together represent one of the fastest growing health challenges worldwide. The distinct mode of action of BI 456906 targets multiple pathways pivotal to metabolic regulation, including those associated with obesity and liver diseases, said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim.1 With our longstanding heritage in cardio-renal-metabolic diseases, we are excited by the findings and potential implications for millions of people who urgently need healthcare solutions.

Launched in March 2021, the phase 2 dose-finding study of BI45906 enrolled adult patients aged 18-75 years with overweight or obesity and randomized them to 1 of 4 doses of once-weekly BI 456906 delivered subcutaneously or placebo therapy. Per trial protocol, patients received escalating doses of BI 456906 for the first 20 weeks and the final 26 weeks of the 46-week treatment period was considered a maintenance phase.1

According to ClinicalTrials.gov, the trial enrolled a total of 387 participants. The primary outcome of interest for the trial was the percentage change in body weight from baseline to week 46. Secondary outcomes of interest included the proportion of patients achieving weight loss equal to or exceeding 5, 10, and 15% of baseline body weight as well as absolute change in body weight, waist circumference, and other metrics. For inclusion in the trial, patients need to be between 18-75 years of age, have a BMI of 27 k/m2 or greater at baseline, and must have undergone at least 1 previous unsuccessful nonsurgical weight-loss attempt.3

In their announcement, Boehringer Ingelheim noted, in addition to the main study results, plans to present an additional analysis of the actual maintenance dose indicating even greater weight loss at ADA 2023. The company also pointed out this agent is also being evaluated in a phase 2 study for adults with nonalcoholic steatohepatitis and liver fibrosis, with this trial expected to be completed in Q4 of 2023.1

We are both enthusiastic about these data and encouraged by the clinical outcomes announced today, said David Kendall, MD, Chief Medical Officer, Zealand Pharma.1 At Zealand Pharma we continue our long-term commitment to the discovery and development of novel differentiated peptide therapeutics that target critical metabolic pathways to achieve substantial weight loss while addressing the complex pathophysiology of overweight and obesity.

References:

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BI 456906 Shows Promise, Reducing Body Weight Up to 14.9%, in ... - MD Magazine

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Have you ever wanted to defy the aging process? Who hasnt? While no one can stop the clock and the passing of time, ageRejuvenation, a local medical spa clinic, can put a plan in place to bring your body back to an optimal level comparable to when your body was the healthiest in your 20s. ageRejuvenation also offers weight loss plans that can help you reach short-term weight loss goals.

Under the medical direction of Dr. Dawn Ericsson, ageRejuvenation is committed to treating symptoms of aging and promoting longer and healthier living regardless of age. Core to its full-scale program is an individualized whole-body approach that helps patients restore their health through hormonal balance, decreased inflammation, improved sexual function and weight loss.

Brett Markowitz, visionary and founder of ageRejuvenation, said it is devoted to customized treatment plans that use advanced diagnostic testing to provide insight into the root causes of symptoms.

We understand that no two individuals are alike, Markowitz said. We also believe that treating the whole body is important. Looking at the thyroid, looking at the hormones, looking at the gut health is essential.

Clients are given a full-body assessment, which includes a lifestyle assessment with regards to stress, blood tests for hormone analysis and an analysis of food sensitivities and intolerances to support gut health.

The average person going through traditional doctors and referrals would go through a whole year and a half to get the assessment and labs we do. We do that, day one. You get answers day one, Markowitz said.

With regards to weight loss goals, ageRejuvenations holistic approach to healthy living ensures clients will have long-term success.

Once you come see us, if you follow what we tell you to do, you are not going to put the weight back on, said Markowitz.

ageRejuvenation has locations throughout Tampa Bay and will be opening additional locations in Atlanta, Georgia and Charlotte, North Carolina. The Brandon office is located at 1155 Nikki View Dr. For more information about the services ageRejuvenation offers, visit http://www.agerejuvenation.com. Call 813-681-8624 for a free consultation.

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Local Med Spa Helps Residents Defy The Aging Process - Osprey Observer

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Published 1:00 pm Wednesday, May 10, 2023

It was the summer of 1991 and I hadnt seen my girlfriend in more than two months.

She was on a summer mission trip to South Dakota, and I had been in Mississippi, trying (not successfully) to get a part-time job that wouldnt require me to cut off my hair and failing to get one (rather successfully).

I was 20 years old and in pretty good shape physically, but about 15 to 20 pounds overweight. I was determined I was going to lose it before my sweetheart returned so I waited until just more than a week from her anticipated return date. Its called planning.

For one week, I would go out into the driveway and stretch, then set off at a jog along the gradual incline toward the interstate bridge from our house in Chunky. It was just at a mile away. Id jog it three times back and forth, a total of three miles, then I would do 100 jumping jacks in the driveway. If I felt like it, Id do as many pushups as I could a few dozen and that would be it. This was my job for the week.

I ate only fruits and vegetables the entire week, and I repeated my odd workout routine daily. It worked. I dropped 15-16 pounds in that week, and looked and felt better.

Though I reincorporated other foods into my diet, I maintained exercise daily and was excited to pick up my girlfriend from the airport. I knew shed be happy for me and glad to see Id noticeably dropped some pounds.

To cut the story short, she didnt notice. In fact, I think when I told her that her response was something like, Oh. OK.

She wasnt impressed, but that was alright with me. I knew Id put in the work and was happy with the results.

It has always been easy for me to gain weight, and for years it was not too difficult to work it off. It just took consistent effort and a proper mental focus. In the last several years, however, the consistent effort has been harder to put in partly due to the long-term degenerative effects of injuries and arthritis, and partly due to the inability to get into a proper mental focus long enough.

But mental focus is where the work really is. I complimented a friend recently on her phenomenal weight loss efforts. She had lost more than 70 pounds and was obviously healthier. She said the only hard thing about it was getting into the proper frame of mind. I knew exactly what she was talking about.

To be successful at anything, we need a proper frame of mind. And I do mean anything. We have to start with it and keep going with it.

The Apostle Paul, in encouraging believers at Philippi, urged them to concentrate their thinking on whatever is true, whatever is noble, whatever is right, whatever is pure, whatever is lovely, whatever is admirable, saying, If anything is excellent or praiseworthy, think about such things (4:8).

A proper frame of mind will get us so much closer to where we need and want to be than anything else we do. Its one reason mental health is so important. May is Mental Health Awareness Month. Take care of yourself. If you need help with your mental health, talk to someone. If your mental health is good right now, take steps to maintain it. Youll be glad you put in the work, and youll be happy with the results.

Brett Campbell can be reached at brett.campbell@dailyleader.com.

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If you have type 2 diabetes youre probably aware that the condition puts you at an increased risk of developing heart disease.

Now, a new study has shown that a class of diabetes medications is associated with fewer major adverse cardiovascular events.

The study, conducted at Vanderbilt University Medical Center, found that GLP-1 drugs like Ozempic (semaglutide) resulted in lower instances of Major cardiovascular events (MACE) than DPP4 inhibitors (another type of diabetes drug) in older veterans with no prior heart disease.

The use of a GLP-1 receptor agonist was associated with a 20% reduced risk of MACE and heart failure hospitalization when compared to treatment with DPP4 inhibitors, which were regarded as neutral in respect to cardiac events.

In other words, these results translate to approximately three fewer heart failure, heart attack, or stroke events per 1,000 people using a GLP-1 medication for a year.

The studys researchers say these findings will help clinicians in choosing a diabetes drug regimen for older patients.

Christianne Roumie, MD, MPH, professor of Medicine in the Division of General Internal Medicine and Public Health and senior author of the study, describes it as an important contribution to patient care and says it adds to what we as clinicians know about treating diabetes and heart disease prevention.

GLP-1 inhibitors have emerged as a promising treatment option for individuals with type 2 diabetes, demonstrating not only effective blood sugar control but also additional benefits like weight loss and reduced risk of cardiovascular disease, says Bari Stricoff, a registered dietitian at Well Easy.

According to Stricoff, the reason someone with type 2 diabetes might experience a reduced risk of cardiovascular disease when taking a GLP-1 drug compared to a DPP4 inhibitor hinges on the effects these drugs have on cardiovascular risk factors.

GLP-1 receptor agonists not only lower blood sugar levels but also have additional cardiovascular benefits, she points out.

Firstly, obesity is a major risk factor for cardiovascular disease, and GLP-1 receptor agonists can promote weight loss by reducing appetite and increasing satiety, Stricoff explains. Secondly, some GLP-1 drugs have been shown to reduce blood pressure, which is an important cardiovascular risk factor.

Additionally, Stricoff says some studies suggest GLP-1s have anti-inflammatory and anti-atherosclerotic effects, both of which can reduce the risk of cardiovascular disease.

GLP-1 medications can also have a positive effect on lipid profiles, such as reducing triglyceride levels, which may contribute to a reduced risk of cardiovascular events, Stricoff adds.

Similarly, Crystal Scott, a registered dietitian at Top Nutrition Coaching, says the results of this study are consistent with previous evidence on the links between GLP-1 drugs and cardiovascular health in people with type 2 diabetes.

Like Stricoff, she points to the cardioprotective effects of GLP-1s, noting how these drugs can improve endothelial function, reduce arterial stiffness, and decrease inflammation, all of which can contribute to the development and progression of cardiovascular disease.

Its important to note that the study was retrospective and observational, so it cannot establish causality or rule out potential confounding factors, she points out.

Future randomized controlled trials are needed to confirm these findings and to determine how these medications can be used optimally to prevent cardiovascular disease in people with type 2 diabetes, she surmises.

Additionally, Scott notes that the study population consisted of U.S. veterans, so the results may not be generalizable to other populations.

Furthermore, the study did not examine the long-term safety and efficacy of these medications, she points out.

While the links between GLP-1 drugs and reduced risk of adverse heart health are promising, Stricoff says, it is crucial to recognize that these medications primarily address the symptoms and consequences of type 2 diabetes rather than the root causes of the disease.

While GLP-1 inhibitors can be life-changing for some patients, they should be considered as part of a comprehensive treatment plan that includes nutrition education and behavioral interventions to promote long-term health and wellness, she surmises.

So, GLP-1s aside, what else can you do to improve your heart health?

Stricoff says lifestyle factors play an important role.

Unhealthy lifestyle choices, such as a poor diet, physical inactivity, and smoking, are common risk factors for both type 2 diabetes and heart disease, and these factors can exacerbate the risk of developing heart disease in people with diabetes, she explains.

Whats more, she says its crucial to pair GLP-1 inhibitor therapy with interventions that target the root causes of type 2 diabetes and promote long-term behavior change.

Nutrition education is a vital component of this approach, as it empowers patients to make informed decisions about their food choices, understand the impact of diet on their health, and adopt healthier eating habits that can be sustained even in the absence of medication, she surmises.

Specifically, Scott advises following a diet that is low in saturated and trans fats, sodium, and added sugars, and high in fiber, whole grains, fruits, and vegetables.

She also recommends engaging in regular physical activity, such as brisk walking, cycling, swimming, or dancing, for at least 150 minutes per week.

Medications often come with a long list of scary side effects, so its certainly promising that GLP-1 drugs are linked with a lower risk of adverse cardiac events. The results of this study may help your clinician choose an appropriate treatment for you.

However, effective as these drugs may be, both experts agree, you shouldnt neglect the basics: eat well, move more, and quit smoking.

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Ozempic and Other GLP-1 Drugs May Help Reduce Heart Attack Risk - Healthline

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In addition to promoting weight loss and treating diabetes, semaglutide drugs like Ozempic and Wegovy may also prevent cognitive decline.

The drugs, which belong to a class of medications called glucagon-like peptide 1 (GLP-1) agonists, work by altering the metabolic system and lowering inflammation throughout the body.

Scientists suspect this could help slow the progression of neurodegenerative diseases like Alzheimers disease and Parkinsons disease.

Trials evaluating these drugs ability to combat cognitive decline are already underway, however, results arent expected until 2025.

But given their ability to fight inflammation, a risk factor for cognitive decline, some health experts suspect they may prove useful in protecting cognition.

These drugs show great promise in slowing or preventing onset of cognitive decline in those at risk for Alzheimers disease, Dr. David Merrill, MD, PhD, an adult and geriatric psychiatrist and director of the Pacific Neuroscience Institutes Pacific Brain Health Center in Santa Monica, CA, told Healthline.

With brain diseases like Alzheimers, a protein called amyloid accumulates and forms plaques.

Over time, these plaques can affect cognitive function.

Some scientists think that diabetes drugs may prevent amyloid buildup.

Alzheimers disease has also been called diabetes type-III, so it is hopeful that in mild cognitive impairment or early-stage Alzheimers disease patients with metabolic syndrome including insulin resistance or frank diabetes will benefit from treatments for diabetes like the GLP-1 agonists, Merrill said.

Recent evidence has shown that anti-amyloid drugs, another type of medication being investigated for Alzheimers disease, may be effective at combating cognitive decline, however, those drugs come with potential serious side effects, like brain bleeding and swelling.

The hope is that semaglutide could lower the risk of cognitive decline without causing serious health complications.

Research is in the early phases and it will take years to determine if the drugs effectively prevent cognitive decline.

Novo Nordisk launched two trials in 2021 that are evaluating semaglutide in people with early Alzheimers. Those results are expected in 2025.

Other pharmaceutical companies, including Neuraly, are testing GLP-1 drugs against Parkinsons disease.

Dr. Irina Skylar-Scott, a cognitive and behavioral neurologist at Stanford Health Care, believes its important to explore novel mechanisms and identify new treatments for Alzheimers disease.

Given the complexity of the disease and prior unsuccessful clinical trials, we need to think outside the box to make strides for our patients, says Skylar-Scott.

Merrill says theres a known link between mid-life obesity and the development of later-life dementia.

Evidence shows that people who are overweight or have obesity face a greater risk of getting dementia down the road.

When obesity is treated earlier in life, the risk for dementia can drop, too.

Skylar-Scott says the role semaglutide may play in Alzheimers disease and vascular dementia is likely independent of its role in weight loss.

GLP-1 can stimulate the release of insulin, thereby improving insulin signaling, reducing inflammation and promoting survival of brain cells, says Percy Griffin, PhD, Alzheimers Association director of scientific engagement.

Some studies have shown that GLP-1 may reduce amyloid and tau accumulation in the brain.

Other reports have found that GLP-1 has anti-inflammatory effects, specifically on the pancreas, liver, vascular system, kidney, lungs, testis, and skin, says Merrill.

Given the mechanisms of action of these kinds of drugs and the biological changes associated with Alzheimers, it makes sense to examine if these drugs can slow down the progression of the disease, Griffin said.

Whether treatment late in life with a drug like Wegovy or Ozempic can benefit those who already have signs of dementia or Alzheimers disease has yet to be seen, according to Merrill.

At this time, there is not enough clinical data to support the use of these drugs in Alzheimers disease, Griffin said.

Because Alzheimers is a complex disease linked to several changes in brain biology, its unlikely that any one treatment would put a full stop to the cognitive decline, says Griffin.

Theres a strong need for an arsenal of medications and modifications that target all aspects of the biological changes to defeat this devastating disease, Griffin said.

This emphasizes the need for an arsenal of medications which target all aspects of the biological changes to defeat this devastating disease, Griffin said.

Researchers are exploring whether semaglutide drugs like Ozempic and Wegovy could help prevent cognitive decline. The drugs work by altering the metabolic system and lowering inflammation throughout the body, which may help protect brain health. Trials exploring the semaglutides impact on cognition are underway and results are expected in 2025.

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Alzheimer's: Ozempic and Similar Drugs May Help Decrease ... - Healthline

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1. Refined Sugars

Added refined sugars are sweeteners that are added to foods and drinks to improve taste. Some popular types of refined sugar include cane sugar, fructose, corn syrup, and agave. Consuming a diet high in added sugars, such as those found in sweetened beverages, sugary cereals, and baked goods, can lead to weight gain and chronic health conditions, including obesity-related diseases like diabetes and heart disease. Excess refined sugar can cause weight gain because it's high in calories while offering little nutrients.

"Refined sugars provide empty calories which can lead to weight gain due to excess calorie intake. They also cause a spike in blood sugar levels followed by a crash, leading to cravings and energy slumps throughout the day," Novak explains. "This makes it difficult to maintain healthy eating habits as well as adhere to a consistent exercise routine. Furthermore, research has linked high-sugar diets with many chronic diseases such as diabetes, heart disease, and obesity." Yikes, nobody wants that!

Instead of refined sugars, Novak recommends exchanging them for natural sweeteners like molasses which, she says, "can provide some health benefits such as increased iron levels and improved heart health."

Another processed ingredient that can lead to weight gain and other health issues is trans fats. Trans fat, also called trans fatty acids, is a type of unsaturated fat that is found in foods like frozen pizza. While small traces of trans fats occur naturally in foods, large amounts are often found in processed foods. And, consuming a lot of trans fat can lead to unwanted weight gain and increases the risk of diabetes, heart disease, and other health problems.

"Trans fats have been linked to a variety of health issues such as high cholesterol, weight gain, and an increased risk of developing heart disease," Novak warns. "Studies have also found that trans fats increase inflammation in the body which can lead to a host of other health problems." Foods high in trans fats also slow your metabolism.

Instead of processed foods high in trans fats, she recommends looking for foods made with whole grains and healthy oils. "Whole grains such as quinoa or oats are packed with vitamins, minerals, fiber, protein, and antioxidants which can help to support weight loss efforts by keeping you fuller for longer periods of time," Novak says. And, she notes, whole grains have been linked to reduced risk of certain cancers and improved heart health.

Healthy oils, like olive oil or coconut oil, Novak says, "contain essential fatty acids and a variety of beneficial antioxidants which can help to reduce inflammation, promote healthy brain function, and boost energy levels." These oils are often better (and healthier) for cooking than other types of oils.

Similar to refined sugars, artificial sweeteners are used as a substitute for sugar to reduce calorie intake and promote weight loss. Although you may have added this sweetener to your coffee, Novak warns though that artificial sweeteners may also be detrimental to weight loss, because of "their ability to change how our bodies regulate appetite hormones." She also adds that artificial sweeteners can contribute to insulin resistance and a slower metabolic rate, which can cause chronic health risks.

Novak also recommends swapping artificial sweeteners with natural sweeteners like honey. "Honey," she says, "is a natural sweetener that can provide some nutritional benefits while still satisfying cravings for sweetness. It contains vitamins, minerals, antioxidants, enzymes, amino acids, and polyphenols which can help to improve digestive health as well as reduce inflammation in the body." Yum!

So, experts like Novak say to avoid processed ingredients like refined sugars, trans fats, and artificial sweeteners. She also recommends eating more fruits and vegetables, drinking enough water, reducing stress levels, getting enough sleep, and exercising regularly. Additionally, she says to consult with a professional to ensure you're meeting your weight loss and long-term health goals.

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Dietitians Agree: Cutting Out These 3 Processed Ingredients Will Help Transform Your Body, Once And For All - SheFinds

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Sharon Osbourne opened up about her experience taking an injectable weight loss drug.

During Thursday's episode of "The Talk UK" the 70-year-old television personality and her fellow panelists discussed the explosion in popularity of the injectable medications Wegovy and Ozempic. The conversation was prompted by the news that Wegovy's U.K. launch has been paused indefinitely due to fears of overwhelming demand and shortages.

Osbourne admitted that she had recently used an injectable weight loss medication, though she didn't specifically name the drug.

"But I took it," "The Osbournes" alum said. "I took it for four months and I lost 30 pounds, but like everything, there's always no quick recipe."

Sharon Osbourne said she lost 30lbs after taking an injectable weight loss drug. (Rodin Eckenroth/WireImage)

She continued, "I was very sick for a couple of months. The first couple of months, I just felt nauseous. Every day I felt nauseous, my stomach was upset, whatever."

SHARON OSBOURNE: WHAT TO KNOW ABOUT THE TV PERSONALITY

"But listen, I took it for four months, I lost 30 pounds. I've just shoved two chips in my mouth, while we had the break, and I eat normally now, and I haven't put on a pound. Nothing."

Panelist Daisy McAndrew argued that changes to diet and exercise don't always result in weight loss for some people.

"It doesn't work like that for a lot of people's metabolism," the journalist said.

"It doesn't," Osbourne replied. "It is a mental problem. It really is, apart from, you know, when children grow up in a household where they live off chips and pies."

The 70-year-old TV personality described some of the negative side effects that she experienced. (Getty Images)

Over the past couple of years, the demand for the medication sold under the brand names Ozempic and Wegovy semaglutide has skyrocketed.

In 2017, Ozempic was approved by the FDA for the management of type 2 diabetes.

After some people began using it for weight loss, it was approved in 2021 under the brand name Wegovy, which is intended for chronic weight management.

Although Wegovy and Ozempic are both semaglutides, Wegovy is available in higher doses, which means it can achieve faster weight loss.

In clinical trials of Wegovy, participants lost an average of 15.8% of body weight over a 68-week period.With Ozempic, the trials showed an average weight loss of 6% over one year.

WHAT TO KNOW ABOUT PRESCRIPTION DRUGS PROMISING WEIGHT LOSS

"Although Wegovy and Ozempic both contain semaglutide, they are different products with different indications, dosages, prescribing information, titration schedules and delivery devices," Allison Schneider a spokesperson for Novo Nordisk, the company that makes Ozempic and Wegovy said in a statement to Fox News Digital.

"The products are not interchangeable and should not be used outside of their approved indications," she also said.

Osbourne said that thought she has stopped taking the drug, she hasn't put on weight. (David M. Benett/Getty Images for Elton John AIDS Foundation)

The most common side effects of semiglutide are nausea, vomiting, diarrhea, abdominal pain, constipation, heartburn and burping, as stated on the MedlinePlus website.

In rare cases, people may experience more intense pain, fainting or dizziness, rashes, vision changes, swelling, difficulty breathing or swallowing, yellowing of the skin and eyes, or rapid heartbeat.

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During a recent segment of "Fox & Friends," Fox News medical contributor and NYU Langone internal medicine specialist Dr. Marc Siegel spoke about his concern regarding prescribing a long-term medication regimen without knowing all the potential side effects and his preference for short-term treatments.

"I dont want to commit people to years and years and years of a drug that I dont know all the potential side effects about," he said. "Id rather use it short-term if I can."

Schneider told Fox News Digital that whether a patient stays on Ozempic or Wegovy long-term or short-term depends on individual health needs and the recommendations of the person's health care provider.

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Fox News Digital's Melissa Rudy contributed to this report.

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Sharon Osbourne reveals she lost 30lbs with injectable weight loss drug, shares extreme side effects - Fox News

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Newswise A new research study published in JMIR Diabetes evaluated the real-world effectiveness of the Fitterfly Diabetes CGM digital therapeutic program for the management of glycemic control and weight in people with type 2 diabetes mellitus. The study led by Shilpa Joshi, Arbinder Singal, and colleagues found significant improvements in both blood glucose levels and weight management in participants enrolled in the 90-day program.

The Fitterfly Diabetes CGM program, delivered through the Fitterfly mobile app coupled with continuous glucose monitoring (CGM) technology, provides users with tailored recommendations on nutrition based on personalized glycemic response data, exercise, and behavior modifications to help manage type 2 diabetes. The program is designed to provide individuals with the tools they need to manage their condition effectively and make long-term lifestyle changes that would support their overall health.

This study analyzed de-identified data of 109 participants with type 2 diabetes. The program was delivered in 3 phases. First, the participants CGM readings were observed for 1 week; next, they received diet- and exercise-based interventions via Fitterfly app and coaches (nutritionists, psychologists, and physiotherapists); and finally, the researchers tracked whether the participants were able to sustain these newly introduced lifestyle modifications over the next 3 months.

The researchers found that, at the end of the 90-day program, about 85% of all participants observed an average reduction of 1.2% in hemoglobin A1c (HbA1c) levels, an important indicator of glycemic control. The reduction was even higher, at about 2.6%, for those participants who started the program with an HbA1c level greater than 9%. The study participants also lost an average of 2.05 kg body weight, and their BMI reduced by 0.74 kg/m2.

Dr Arbinder Singal, CEO and cofounder of Fitterfly, said, Type 2 diabetes is a huge health care concern in India. With the use of newer tools such as digital therapeutics now getting adopted by people and enterprise partners, and getting prescribed by physicians, we are bridging the gap for behavior change. The study affirms our belief that digital therapeutic programs can provide clinically validated outcomes and help the population at scale.

The program's easy-to-use app interface and personalized approach make it a promising option for individuals looking to improve their health and manage diabetes effectively. Interestingly, the study also found that participants who engaged more with the app throughout the programs duration had better clinical outcomes, especially with regard to weight reduction. Thus, Fitterflys CGM program could be a valuable tool for health care professionals in managing type 2 diabetes and supporting weight loss goals.

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About Fitterfly

Fitterfly is a healthtech start-up working in the area of metabolic health offering outcome-focused digital therapeutic programs for conditions like diabetes, obesity, and heart disease. Founded in 2016 by Dr Arbinder Singal and Shailesh Gupta, Fitterfly has over 300 employees and has headquarters in Mumbai, India. The Fitterfly management team comprises senior doctors, nutritionists, fitness experts, psychologists, management experts, and technologists working together with the sole aim of preventing, reversing, and managing metabolic health conditions such as prediabetes, diabetes, obesity, hypertension, and heart disease, thereby increasing quality of life and health for people.

Fitterfly has presented and published more than 50+ abstracts and papers on outcomes and impact of technology in disease management. Apart from path-breaking research, Fitterfly has won several coveted awards in the start-up and health care arena, such as Economic Times Healthtech Start-up of the Year 2022, Zee News Healthtech Start-up of the Year 2022, Global Digital Health Award 2022, RSSDI Award for Innovation in Diabetes 2021, Medix Healthtech Challenge 2021, and Healthtech Start-up of the Year 2021 by Entrepreneur.

More information about Fitterfly is available at http://www.fitterfly.com or connect with us via Twitter, Linkedin, Youtube, Facebook, and Instagram.

About JMIR Publications

JMIR Publications is a leading, born-digital, open access publisher of 30+ academic journals and other innovative scientific communication products that focus on the intersection of health, and technology. Its flagship journal, the Journal of Medical Internet Research, is the leading digital health journal globally in content breadth and visibility, and is the largest journal in the medical informatics field.

To learn more about JMIR Publications, please visit jmirpublications.com or connect with us via Twitter, LinkedIn, YouTube, Facebook, and Instagram.

Head office: 130 Queens Quay East, Unit 1100, Toronto, ON, M5A 0P6 Canada

Media contact: [emailprotected]

The content of this communication is licensed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, published by JMIR Publications, is properly cited.

Please cite the original article as:

Joshi S, Verma R, Lathia T, Selvan C, Tanna S, Saraf A, Tiwaskar M, Modi A, Kalra S, K V, Chitale M, Malde F, Abdul Khader M, Singal AKFitterfly Diabetes CGM Digital Therapeutics Program for Glycemic Control and Weight Management in People With Type 2 Diabetes Mellitus: Real-world Effectiveness EvaluationJMIR Diabetes 2023;8:e43292doi: 10.2196/43292

PMID: 37133922

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New study finds that Fitterfly Diabetes Digital Therapeutics Program Improves Blood Sugar Levels and Promotes Weight Loss in Patients With Type 2...

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Bariatric surgery is a life-changing procedure. Its one of the most momentous decisions a person can make, and its one that should be carefully deliberated before reaching a final conclusion.

As people think about what their lives will look like post-surgery, theyre most excited about how the procedure will transform their bodies. They spend hours consulting with their medical teams, reading articles online, and following the success stories of other bariatric surgery patients to anticipate the benefits theyll soon enjoy themselves. And while its okay for them to lose themselves in the excitement, its essential they consider the risks too.

Im not going to discuss the medical risks of bariatric surgery in this article. Thats a conversation they should be having with you, their medical team. I want to discuss the less talked-about risk that comes after a complete physical transformation. Bariatric surgery can help get people closer to their dream bodies, but they dont often think about how it could impact their mental health.

As many as one in five patientsgain at least 15 percent of their weight back in the years following their procedure. But what people dont always know is that a number of patients also report feeling more depressed and anxious post-surgery. This shift doesnt always happen, nor does it always happen immediately, with most people experiencing a newfound sense of euphoria after their procedure. Its usually a gradual decline that occurs over several years. This isnt entirely uncommon given the biological, lifestyle, and social changes that patients have to learn how to navigate post-surgery. But a decline in mental health can actually sabotage the surgerys success.

We want our patients to be the best versions of themselves after bariatric surgery. Helping them understand the emotional impact it can have on their life can mentally prepare them for their transformation. Below are the most significant mental health triggers you should discuss with your patients.

Bariatric surgery buyers remorse

People believe that if they spend enough time thoroughly deliberating their decision and weighing their options, they can walk into their surgery with absolute confidence they made the right decision. But in the days, weeks, and months following their surgery, they may feel that assurance quickly fade as they find themselves regretting their choices. Many people wonder how its possible to second-guess themselves when they were so sure bariatric surgery was the best decision for them, but we know this as bariatric surgery buyers remorse.

Most patients feel buyers remorse as a response to their recovery difficulties. The strict guidelines they must follow as they learn how to eat and drink again with your new stomach might have felt worth it in their planning phase, but now that they have to follow these guidelines, its more overwhelming than they imagined.

Its our responsibility to inform them that this regret is usually temporary, but it can serve as a reminder of why its so important to surround themselves with a good support system. This support can include a partner, family, or friends, but it can also include their provider. Community and support are critical to a patients success, especially during the early stages of recovery. This is why at Be Slim Bariatrics, we provide ongoing support to our patients at no additional cost, medical and nutrition-wise. Our bariatrics packages also include access to a large peer support group which is supervised by our team of dedicated health professionals.

Losing food as a source of comfort

Most bariatric patients share a similar relationship with food. Some patients turn to food and eating for comfort. Food can bring cheer when one is depressed or anxious, but its also a crutch that can help bolster ones happiness and enjoyment.

Bariatric surgery changes this entire dynamic. Food can no longer be a source of comfort, which can stir up some complicated emotions that people have abetted by eating for so long. Bariatric patients can have a difficult time processing these unpleasant emotions while in the midst of a challenging recovery process. They might feel an intense urge to eat, and when they cant, they will grieve the loss of food.

Providers must work with patients to change their relationship with food and help them discover healthy coping mechanisms to aid in their recovery and long-term success, like prioritizing self-care activities, spending more time with their loved ones, or finding other habits to occupy their minds. Behavioral modification is essential in the weight loss journey of a bariatric patient. It should be provided through a medically supervised weight management program like Be Slim Bariatrics offers.

Reclaiming ones self-esteem

Bariatric surgery is not a magical cure-all for poor self-esteem. Bariatric patients might find themselves struggling even more with their self-confidence after their surgery than before. There are a few reasons for this.

First, patients often feel insecure that theyve had to turn to surgery to lose weight. Society tells us that through diet and exercise, all things are possible. This isnt only wrong, but its a dangerous mindset that continues to fuel harmful inaccuracies about weight loss. Opting to undergo surgery to get someone closer to their goal weight isnt taking the easy way out, its a personal commitment to achieving greater physical health. And second, losing excess weight can often elicit an identity crisis. It might take patients some time to believe they are actually the person who is staring back at themselves in the mirror and thats okay. It will take time for patients to reclaim their sense of self and learn how to love this new version of themselves. We should encourage them to give themselves grace and patience.

Bariatric surgery isnt just a physical transformation; its a mental metamorphosis. Our patients physical and mental well-being are interconnected, so helping them care for and heal both sides of themselves is crucial.

Photo:mi-viri, Getty Images

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The Emotional Impact of Bariatric Surgery: Helping Patients ... - MedCity News

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