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The humanization trend in pets is quickly extending to weight loss drugs.Vivani Medical, a biopharmaceutical company, recently announced results for its new miniature drug implant, OKV-119, designed to treat obesity and diabetes in cats.

The positive weight loss data was published in peer-reviewed BMC Veterinary Research. Vivani has partnered with Okava Pharmaceuticals to develop OKV-119 using their NanoPortal technology for feline prediabetes, diabetes and obesity. The results of the small study showed the implant treatment helped cats lose at least 5% of their body weight over 112 days.

Researchers estimated that up to 40% of the domestic cat population needs help managing their weight, and feline obesity is now one of the most common challenges encountered at veterinary offices, said Vivani. From previous reporting on PetfoodIndustry.com,a 2022surveyby the Association for Pet Obesity Prevention noted61% of evaluated cats as overweight or obese.

The data published in BMC Veterinary Research is further evidence that our proprietary NanoPortal implant technology holds promise in reducing obesity in cats, said Adam Mendelsohn, Ph.D., Vivani president and CEO. Felines share many pathophysiologic obesity phenotypes with humans, and our preclinical studies of NPM-115 and NPM-119 in other animal models, in addition to this cat data, support our efforts to clinically evaluate our miniature, subdermal GLP-1 implants for the treatment of chronic weight management in obese or overweight human patients and type 2 diabetes, respectively.

"Vivani is dedicated to rapidly developing our portfolio of weight loss focused implants as they collectively have the potential to improve medication adherence, tolerability and real-world patient results," Mendelsohn added.

The study includedfive purpose-bred neutered male cats. At the time of enrollment, the cats were 28 months old, weighed (median, range) 5.61kg (5.14 7.38kg), and were considered healthy based on physical examination. The general health of each animal was assessed during the course of the 112-day study period.

To allow for the measurement of daily caloric intake, cats were individually housed in pens from Day 6 to Day 28 and fed a standardized pelleted feline diet (Purina Cat Indoor formula), with 90grams of fresh feed provided once daily in the morning. Cats were offered canned wet food (Friskies Meaty Bits) to induce eating if caloric intake was too restricted.

After Day 28, cats were removed from individual pens and were collectively provided 450grams of the dry pelleted food for the remainder of the study period. The amount of food provided and consumed was recorded throughout the study. Water was supplied ad libitum. Daily physical exams were performed, while body weights were measured weekly. Weekly plasma samples were taken during the study for the measurement of exenatide concentrations.

The study evaluated the drug release characteristics of subcutaneous OKV-119 implants configured to release exenatide for 84 days. Key findings included:

Vivani has separately demonstrated the delivery of exenatide over a 6-month duration bothin vitroandin vivo(in a rat) and anticipates extending the duration of OKV-119 to 6 months for future studies.

In February,Better Choice, a pet health and wellness company and maker ofHalo Elevatepet foodbrand, acquiredAimia Pet Healthco Inc.The company said the acquisition allowed it tobe in a better position to manage the clinical trials internally in hopes to develop a supplement to support weight loss in domestic animals.

In addition to working with Animiato develop treats and toppers to safely combat pet obesity,Better Choice noted the goalof the research and development work between the companies is to mirror the weight loss benefits of leading brands for domestic animals and in humans including Slentrol, Wegovy, Ozempic and Mounjaro with added protein and nutrients from the companys Halo products to promote lean muscle and overall pet health.

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Study shows positive results for cat weight loss implant - PetfoodIndustry.com

NEW ORLEANS We've been bringing you the latest updates on those injections for weight loss, and diabetes. And now there's another finding you might think is surprising. Nationally, pregnancy rates are increasing in women using the injections.

And there are a few reasons why this is happening. The weight loss and diabetes injections are helping some women get pregnant, who before, have been trying without success. I would say three to five patients a month who that, who come in, who are actively utilizing one of those medications, and yes, we've had some spontaneous conceptions based on the fact that the patient has lost weight utilizing these meds, said LSU Healths Dr. Jay Huber, III, an OB-GYN, fertility specialist who is Medical Director of The Fertility Institute. He says preliminary studies are showing those GPL-1 antagonist injections are associated with a higher pregnancy rate. But that's not very surprising, right? Anything that can cause improved metabolic status, and weight loss, can overall improve the ability for couples to conceive, he explained. That's because fat cells produce, and can disrupt hormones. In fact, Dr. Shauna Levy even sees increased pregnancies in her patients who had bariatric surgery for weight loss. They may have spent years, and years trying to get pregnant, and they never could, and then all of a sudden, they're one-month post-surgery, and they accidentally, they have an unintended pregnancy, said bariatric surgeon and Medical Director of the Tulane Weight Loss Center, Dr. Shauna Levy. And the weight loss injections are also helping those with with polycystic ovary syndrome, called PCOS, conceive. That's right. Anything that can improve weight, can reduce weight, will have a positive impact on patients with PCOS, said Dr. Huber. And there's another question about pregnancy. Are those injections keeping the birth control pill hormones from absorbing in your blood, and allowing an unintended pregnancy? It's a theoretical risk that certain hormones, or hormonal contraceptives, could have a slower rate of absorption and potentially lower chances of effectiveness, said Dr. Huber. He says the risks are very low. Dr. Levy says the most risky time is during the first six months, as your injection dose is slowly increasing, and your digestion time is adjusting. During that ramp-up period is when you really need that second birth control, because we don't know exactly what's happening to the birth control pills and your absorption may be less, explained Dr. Levy. So, let your OB-GYN know you are taking those medications.

And this is important. It's still unknown if the injections are safe, or can harm, your unborn baby. There are reports of babies born healthy, but animal studies show side effects.

So, they say to use birth control if you are on them.

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Surprising finding on weight loss injections and pregnancy - WWLTV.com

Weight loss drugs Ozempic and Wegovy have become blockbuster successes in the past year. Now they could assume a new role, according to research from Virginia Commonwealth University treating liver disease.

A study from the VCU Stravitz-Sanyal Institute for Liver Disease and Metabolic Health indicates those drugs can be combined with another medicine to reduce levels of liver fat and inflammation and cease scarring.

Turbocharging the Ozempic through the combination could become a game-changer for treating liver disease, said Dr. Arun Sanyal, the principal investigator for the study and the director of VCUs liver institute.

These findings are remarkable and exciting and open a new chapter in drug development for liver disease, Sanyal said.

Turbocharging the Ozempic through the combination of other medicines could become a "game-changer" for treating liver disease, said Dr. Arun Sanyal, the principal investigator for the study and the director of VCU's liver institute.

Made by Denmark-based Novo Nordisk, Ozempic and Wegovy are two forms of the same drug used to treat obesity and diabetes.

Since last year, they have skyrocketed in popularity in the United States. Ozempic sales reached almost $14 billion last year, with most sales coming from the U.S.

Ozempic is known as a GLP-1 agonist because it mimics a hormone called glucagon-like peptide-1, which stimulates insulin production in the pancreas, helps lower blood sugar levels and leads to weight loss.

Obesity, diabetes and liver disease are often correlated. More than 33 million Americans have Type 2 diabetes, and between 5% and 7% develop significant liver disease, Sanyal said.

By itself, Ozempic does not treat liver disease.

But by combining the GLP-1 agonist with another agonist, the new drug has the potential to do what Ozempic cannot. It has shown the ability to reverse scarring, for which few medicines have shown such potential.

The combined drug is called survodutide, which has been used for treating liver disease since 2021. Scientists now refer to nonalcoholic fatty liver disease as metabolic dysfunction-associated steatohepatitis, or MASH.

A healthy liver has a small amount of fat, but when the fat exceeds 5% of a livers weight, the fat can lead to serious health issues, such as cirrhosis and liver cancer. Serious scarring typically cannot be reversed and the only treatment is a liver transplant. Many patients often develop liver disease for years without displaying symptoms and do not become aware of their disease until it is too late.

The study involved 293 adults from 25 countries with MASH and varying stages of scarring. Some were given survodutide and others, placebos.

After 48 weeks of treatment using survodutide, up to 83% of participants saw measurable improvement of their disease, including lower levels of liver fat, inflammation and no worsening or scarring of the liver, known as fibrosis.

Three out of four patients showed their disease had resolved, meaning their livers were significantly less inflamed, fatty and scarred. Up to half of patients showed their liver enzymes and fibrosis improved a major success for the medicine.

Side effects such as nausea, diarrhea and vomiting were common. The results were published last week in the New England Journal of Medicine.

Another phase of the trial is underway to determine if survodutide can help overweight or obese patients with fatty liver disease to lose weight and reduce their liver fat.

Only one drug, called resmetirom, has FDA approval to treat fatty liver disease.

In 1630, Englishman John Winthrop, leading a fleet carrying Puritan refugees, arrived at the Massachusetts Bay Colony, where he became its governor.

In 1942, Anne Frank, a German-born Jewish girl living in Amsterdam, received a diary for her 13th birthday, less than a month before she and her family went into hiding from the Nazis.

In 1963, civil rights leader Medgar Evers, 37, was shot and killed outside his home in Jackson, Mississippi. (In 1994, Byron De La Beckwith was convicted of murdering Evers and sentenced to life in prison; he died in 2001.)

In 1964, South African Black nationalist Nelson Mandela was sentenced to life in prison along with seven other people, including Walter Sisulu, for committing sabotage against the apartheid regime (all were eventually released, Mandela in 1990).

In 1978, David Berkowitz was sentenced to 25 years to life in prison for each of the six Son of Sam .44-caliber killings that terrified New Yorkers.

In 1987, President Ronald Reagan, during a visit to the divided German city of Berlin, exhorted Soviet leader Mikhail S. Gorbachev to tear down this wall.

In 1994, Nicole Brown Simpson and Ronald Goldman were slashed to death outside her Los Angeles home. (O.J. Simpson was later acquitted of the killings in a criminal trial but was eventually held liable in a civil action.)

Former mobster Henry Hill, the subject of the movie Goodfellas, died in Los Angeles a day after his 69th birthday.

On June 12, 2016, a gunman opened fire at the Pulse nightclub, a gay establishment in Orlando, Florida, leaving 49 people dead and 53 wounded; Omar Mateen pledged allegiance to the Islamic State group during a three-hour standoff before being killed in a shootout with police.

In 2018, after a five-hour summit in Singapore, President Donald Trump and North Korean leader Kim Jong Un signed a joint statement agreeing to work toward a denuclearized Korean Peninsula, although the timeline and tactics were left unclear; Trump declared that he and Kim had developed "a very special bond."

One year ago: Rayshard Brooks, a 27-year-old Black man, was shot and killed by one of the two white officers who responded after he was found asleep in his car in the drive-thru lane of a Wendys restaurant in Atlanta; police body camera video showed Brooks struggling with the officers and grabbing a Taser from one of them, firing it as he fled. (An autopsy found that Brooks had been shot twice in the back. Officer Garrett Rolfe faces charges including murder.

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VCU study: weight-loss drug Ozempic could treat liver disease - Richmond Times-Dispatch

Affordable Care Act (ACA) Marketplace plans rarely cover GLP-1 drugs approved solely for obesity treatment, according to a new KFF analysis of 2024 federal plan data. Wegovy, a drug that is approved for weight loss, is covered by just 1% of Marketplace prescription drug plans, compared to 82% of Marketplace prescription drug plans for Ozempic, which contains the same active ingredient as Wegovy (semaglutide) but is approved only for diabetes.

When GLP-1 drugs are covered for diabetes treatment, almost all plans use at least one utilization management strategy to control costs, such as prior authorization or quantity limits. Of the few Marketplace plans that cover GLP-1 drugs approved for obesity, all require prior authorization.

Utilization management tools are intended to balance cost control and access but may still pose barriers for people with a medical necessity to take these drugs. While insurers receive rebates to offset some of their costs, the list prices of GLP-1 drugs are about $1,000 per month, and growing demand for these medications could put upward pressure on premiums.

This analysis examines publicly available formularies of plans available on the federally facilitated ACA Marketplaces in 2024 and does not include states that run their own Marketplaces, where coverage patterns may differ. The ACA Marketplaces represent a small share of people with private health insurance, as most people with private coverage have plans sponsored by their employers. While information on employer plan formularies is not publicly available, these plans may be more likely to cover drugs for weight loss than ACA Marketplace plans given the desire to attract workers, though they may employ similar utilization management strategies.

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Costly GLP-1 Drugs are Rarely Covered for Weight Loss by Marketplace Plans - KFF

Starting your day with a balanced, nutritious breakfast is an easy and effective way to support your health.

Eating a protein and fiber-rich breakfast can promote optimal blood sugar regulation and give you sustained energy. It can also keep you full until your next meal and reduce your overall calorie intake, which could help you reach your weight loss goals.

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Eggs are rich in protein, easy to make, and serve as the base for several breakfast dishes, like egg muffins. You can make egg muffins by mixing eggs with chopped vegetables and a small amount of cheese, and then pouring the mixture into muffin tins and baking in the oven until solid. These are easy to meal prep; just make a bulk batch and freeze for later use.

Two eggs provide 12.52 grams (g) of protein, which is the most filling macronutrient. In addition to being high in protein, eggs are low in carbs and rich in essential nutrients like B12, selenium, and vitamin A.

Following diets higher in protein and lower in carbs is linked to several health benefits, including improved blood sugar regulation, reductions in heart disease risk factors like high triglyceride levels, and weight loss.

Also, studies show that eating eggs for breakfast may help you take in fewer calories later in the day, which can help encourage fat loss.

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Greek yogurt contains more than double the amount of protein found in regular yogurt, making it a smart choice for a weight loss-friendly breakfast. A 7-ounce (oz) container of Greek yogurt provides just under 20 g of protein, which can help youfeel satisfiedafter eating.

Topping Greek yogurt with fiber-rich foods can further boost your breakfast's weight loss-promoting potential. Protein and fiber both slow digestion, which increases feelings of fullness and helps you eat fewer calories, which encourages weight loss. For example, research shows that pairing yogurt with fiber-rich chia seeds leads to greater feelings of fullness compared to eating plain yogurt.

Try layering Greek yogurt with high-fiber ingredients, like chia seeds and berries, for a quick, yet satisfying breakfast.

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Oats, including rolled oats and steel-cut oats, are a popular breakfast choice as they're nutritious, filling, and versatile.

Though steel-cut oats take a bit longer to prepare than rolled oats, they're higher in protein and fiber, making them a better option for promoting satiety. A quarter-cup of steel-cut oats contains 5 g of protein and 4 g of fiber.

Top steel-cut oats with peanut butter for added protein and flavor. Look for a peanut butter with minimal added sugar to help reduce your sugar intake.

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Protein powdersare a helpful ingredient to keep in your kitchen as you can use them to prepare quick and nutritious meal and snack options, like protein shakes and smoothies.

If you're looking for a weight loss-friendly breakfast option that can be taken on the go, consider whipping up a protein-packed smoothie made with whey protein, frozen berries, nut butter, and water, milk, or plant-based milk. One scoop of whey protein isolate provides 25 g of protein, making it a satiating ingredient that can help boost weight loss and increase muscle mass.

A research review found that people who supplemented with whey protein experienced significant reductions in body weight and body fat compared to those who received placebo treatments.

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If you follow a plant-based diet or can't eat eggs, it can be challenging to find protein-rich breakfast options. Legumes, like chickpeas, are high in plant-based protein and fiber and can be used to prepare filling breakfast dishes.

Chickpeas provide 12.5 g of fiber per cooked cup. Fiber helps slow digestion, which helps you feel fuller after eating.

Research findings suggest that adding chickpeas and other legumes to your diet can reduce your hunger levels and help you eat fewer calories throughout the day, which can support weight loss and prevent weight gain. A recent study found that adults who ate more legumes, like chickpeas, had significantly less weight gain over a 10-year time period compared to adults with low legume intake.

To make a vegan-friendly breakfast, saut chickpeas with cubed sweet potatoes and sliced onions until the onions are caramelized and the sweet potatoes are soft.

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Combining protein-packedeggswithhigh-fiber vegetables creates a filling and nutrient-dense breakfast that will keep you satisfied through the morning.

Protein and fiber increase feelings of fullness by stimulating the release of satiety hormones such as peptide YY (PYY) and cholecystokinin (CCK) and slowing digestion, which can help you eat fewer overall calories.

You can make a frittata by combining whisked eggs, your favorite vegetables, herbs, and seasonings in a pie dish or cast iron skillet and baking at 400 for around 20 minutes.

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Though most people enjoy oats with sweeter ingredients, like fruit, oatmeal makes a healthy base for savory breakfasts, too.

Try making savory oatmeal by mixing cooked steel-cut or rolled oats with salt and pepper and topping your oats with protein and fiber-packed ingredients like eggs, cheese, and vegetables.

Oats can boost feelings of fullness after eating and support overall health by reducing heart disease risk factors like LDL cholesterol and improving the health of the digestive system.

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Chia seedsare packed with nutrients that support satiety and a healthy body weight, like fiber and protein. Chia seeds contain nearly 10 g of fiber per ounce, which helps you feel full. Fiber-rich foods, like chia seeds, also promote digestive health by keeping bowel movementsregular and encouraging the growth of beneficial bacteria in the gut.

To make chia pudding, combine 2 tablespoons (tbsp) of chia seeds with a half-cup of milk of your choice, such as cow's milk or coconut milk. Let the mixture sit in the refrigerator until it takes on a thick, pudding-like consistency. Top chia pudding with other nutritious, high-fiber ingredients, like seedsand berries.

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If you're craving something sweet yet nutritious, consider making protein pancakes. They require just a few ingredients and take minutes to prepare.

To make protein pancakes, blend 2 1/2cupsof rolled oats, two bananas, and two eggs in a high-speed blender until smooth. Pour the mixture in small dollops onto an oiled skillet and cook for 2-3 minutes per side on medium heat until the pancakes are fully cooked through.

Top your protein pancakes with Greek yogurt and berries for a sweet and satisfying breakfast option.

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Cottage cheese contains 23.5 grams of protein per cup, making it a good choice for those who want to lose weight. In addition to protein, cottage cheese provides vitamins and minerals that are essential to overall health, including calcium andB12.

Cottage cheeseis versatile and can work as a sweet or savory breakfast option. For a boost of fiber, top your cottage cheese with fresh fruit, like berries or sliced peaches, and chopped walnuts.

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If you struggle to find the time to prepare a healthy breakfast, a protein bento box can provide the energy you need to power through your day.

To make a protein-packed bento box, choose a few nutritious, high-protein foods, like hard-boiled eggs, hummus, and cheese, plus high-fiber foods, like fresh fruits and vegetables, and place them into a container with multiple compartments to keep your ingredients separated. You can make a few of these containers ahead of time to have for the week.

Try mixing up your protein bento box combinations to keep your breakfast options interesting and satisfying.

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If you think salad can only be eaten for lunch or dinner, think again. Greens, like arugula andspinach, are very low in calories and make a nutritious base for a filling breakfast.

To make a breakfast salad, top your favorite leafy greens with protein-rich ingredients like fried or hard-boiled eggs, cooked or raw vegetables, beans, cheese, and seeds.

Dress your salad with olive oil and apple cider or balsamic vinegar to add flavor and additional health benefits.

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Eating fiber-rich whole grains and pseudo grains, like quinoa, brown rice, and buckwheat, is associated with a number of health benefits.

For example, research suggests that people who eat whole grains are less likely to gain weight and develop obesity over time compared to people who eat refined grains.

For a quick, weight loss-friendly breakfast, top cooked quinoawhich is higher in protein than many other grainswith filling ingredients like eggs and sauted vegetables.

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Avocadosare packed with fiber, providing 13.5 g per avocado.

Study findings suggest that people who regularly consume avocados have less stomach fat and are less likely to gain weight over time compared to people who don't eat avocados.

For a simple breakfast, top whole-grain or gluten-free toast with mashed avocado and sliced hard-boiled eggs.

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Breakfast wraps are a smart choice if you're looking for a satisfying breakfast you can enjoy on the go.

Use a whole-grain, gluten-free, or low-carb wrap to roll up filling and nutrient-rich ingredients like eggs, beans, and vegetables.

You can customize your wrap based on your dietary preferences and health needs. For a vegan-friendly, high-protein breakfast, stuff your breakfast wrap with sauted veggies and scrambled tofu, which packs over 9 g of plant-based protein per 3 oz serving.

If you're trying to shed excess body fat, it's important to do so using safe and effective methods. It's best to avoid overly restrictive and very low-calorie diets, as these can be difficult to maintain and may cause you to develop a harmful relationship with food.

Instead, focus on transitioning to a nutritious diet high in filling foods, such as foods rich in protein and fiber, while limiting foods and drinks linked to weight gain and other health concerns, such as foods high in added sugar, fast food, and soda.

Remember to maintain proper serving sizes when eating nutritious foods high in protein and fiber, like the breakfasts above. These foods allow you to more easily reduce calories while still getting the nutrients you need, aiding in weight loss.

It's essential to create a calorie deficit to achieve weight loss. You can do this by eating fewer calories throughout the day or by increasing your energy expenditure by engaging in more physical activity.

It's important to note that extreme calorie restriction can lead to side effects such as a loss of muscle mass, increased appetite, and a drop in the number of calories you burn while at rest, which can make it difficult to maintain your weight loss long term.

To minimize these unwanted effects, many experts recommend creating a smaller calorie deficit, which may result in slower weight loss but can increase your chances of keeping the weight off long term.

While there are many evidence-based ways to support healthy weight loss, it's best to work with a qualified healthcare provider, like a registered dietitian, to come up with a weight loss plan that works best for your specific health needs and goals.

Eating a nutritious, balanced breakfast can help you start the day feeling full and energizedwhich can be an effective way to support weight loss.

Research shows that eating a breakfast high in protein and fiber-rich foods, like eggs, vegetables, beans, and Greek yogurt, can help improve feelings of fullness and help you eat fewer calories later in the day, encouraging healthy weight loss.

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15 Best Breakfasts for Weight Loss - Health.com

The program credits its success to the power of group dynamics.

Insta360, a tech company in Shenzhen, China, has gained recognition for its unique employee wellness program. The program incentivizes weight loss by offering nearly USD 140,000 in total bonuses.

Launched in early 2023, the program boasts impressive results. According to Jiupai News, over 150 employees collectively lost 800 kg and earned nearly USD 100,000 in rewards.

Structured like a weight-loss boot camp, the program lasts three months and enrols 30 employees per session, prioritizing those with obesity. As reported by the South China Morning Post, each session is split into three groups, with bonuses awarded based on average weekly weight loss within each group.

The program credits its success to the power of group dynamics. No participants gained weight during the camps, highlighting the added motivation it provides.

"Creating groups adds a moral dimension for employees," said Li, a staff member. "If you don't slim down, you affect not only your bonus but also that of your colleagues."

Li, who joined in November 2023, found the program appealing for both financial reasons and his health. He combined a controlled diet with daily exercise like running, swimming, and basketball, resulting in a 17.5 kg weight loss and a 7,410 yuan (US$1,000) reward.

The initiative received lots of praise on Chinese social media.

A user wrote, "What a fairy company it is. I wish I could work there."

Another user commented, "I would run 10 km every day and the company would soon be bankrupt with a staffer like me."

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"Lose Weight, Get Bonus": Chinese Tech Company Offers Weight Loss Incentives - NDTV

Shes no friend of store-bought blends.

Premade smoothies and cocktails, as well as frozen dinners, should be avoided if youre trying to shed pounds, a Georgia womensweight-loss coach claims.

These foods Im seeing eaten in excess, not moderation, which can make weight loss really difficult, Jenna Rizzo said in a Monday TikTok that has garnered more than 28,200 views.

The American Heart Associationrecommendsconsuming 4 cups offruitevery day but Rizzo says store-bought smoothies and aa bowls arent the way to go.

They are going to be loaded with a bunch of added sugars, and the fruits and vegetables they use are often just a powder, so youre not even eating real food, Rizzo said.

So thats why I say, just make these things at home, she continued. Youre going to be using real food, and youre not going to be adding a cup of sugar to them.

These foods are very calorie-dense, so that means youre only getting a little bit of food for a lot of calories, Rizzo explained. So this can make portion control really hard, because you dont want just a little, tiny slice of pizza, you want three [or] four.

She added: And these foods typically just dont have the best ingredients in them.

Research has linked ultra-processed foods like frozen dinners to a higher risk of premature death, heart disease, colorectal cancer, obesity, depression and other serious conditions.

Consuming alcohol can make it harder to lose weight booze is high in calories and it can interfere with fat burning.

Rizzo calls herself an alcohol hater, especially the premixed cocktails.

You got to think of the juices, the syrups that are added into these cocktails, which will skyrocket the amount of calories, Rizzo said. So you can easily drink hundreds to even thousands of calories in one night. And to add on top of that, I dont know about you, but if I get a little tipsy, I get the drunk munchies really bad.

Continued here:
Weight loss coach reveals 3 foods that could sabotage your goals - New York Post

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Effects of weight loss intervention on anxiety, depression and quality of life in women with severe obesity and polycystic ... - Nature.com

GLP-1 receptor agonists are very effective at helping obese and overweight patients lose weight, but reductions in muscle accompany the fat loss. Mounting evidence suggests muscle loss contributes to poor health outcomes, especially for elderly patients, but clinical trials rarely incorporate the quality of weight lossmuscle vs. fatinto their analyses.

Instead, in obesity, primary trial endpoints for glucan-like peptide-1 (GLP-1) receptor agonists usually measure only reductions in body weight or body mass.

Some drug developers are recognizing that body composition matters. Veru Pharmaceuticals, Regeneron and Altimmune, in clinical trials, and Eli Lilly, in preclinical development, are each working on GLP-1 companion therapeutics that either build or conserve muscle mass.

GLP-1 inhibitors were first shown to lower plasma glucose in 1993, but the attention given to fat-vs.-muscle loss is relatively new. Therefore, the FDA, citing its 2007 draft guidance for industry, Developing Products for Weight Management, still does not recommend using changes in either fat mass or lean mass as endpoints in clinical trials for weight loss drugs. As an FDA spokesperson told BioSpace, To date, we have not identified an adverse clinical impact related to reductions in lean mass.

Others, including Fatima Cody Stanford, associate professor of medicine and pediatrics at Harvard Medical School, writing in JAMA, consider weight loss alone an inaccurate measurement of a medications efficacy. More concerningly, a literature review notes that low muscle mass contributes to a variety of conditions, including mortality.

In managing weight loss, Theres a balance between having good quality weight loss and having a metabolic reset so patients dont have to stay on these therapies for too long, Mayank Mamtani, head of healthcare research at B. Riley Securities, told BioSpace.

Key opinion leaders recognize that, according to Global Data. When interviewed by the industry analyst, they called for changes in the clinical trial design to assess the quality of weight loss so that healthcare providers can better select therapeutic options for their patients. Specifically, they suggested using bioelectrical impedance analysis (BIA) and dual-energy X-ray absorptiometry (DEXA) scanning to better assess body composition during weight loss.

To ensure that drug-induced weight loss is caused primarily by a reduction in fat mass, the FDA recommends that sponsors . . . conduct an evaluation of body composition . . . in a representative sample of subjects enrolled in the clinical trials, the same FDA spokesperson told BioSpace. DEXA or a suitable alternative is recommended.

However, DEXA and MRI measure lean mass, not muscle mass, Scott Harris, chief medical officer at Altimmune, told BioSpace. Lean mass includes muscle, but it also includes integuments and other soft tissue. MRI can distinguish muscle from lean mass, but the techniques are not universally accepted, so studies usually report out on lean mass instead.

If the trial is not set up with [either DEXA or magnetic resonance imagingMRI] modalities in advance, lean mass and fat mass cannot be assessed, Harris said. Altimmune is developing a dual-action therapeutic, pemvidutide, that, in Phase II trials,reduced appetite and preserved lean muscle mass.

As the FDA notes, weight loss involves the loss of both fat and muscle mass, regardless of whether the loss occurs through pharmacotherapy, bariatric surgery or lifestyle changes.

A reduction in fat-free mass can occur because, with lower fat mass, there is less weight acting on skeletal muscle (leading to reduction in bone and muscle mass), reduced organ size (liver, kidneys and pancreas), and reduced body water weight. These changes in body composition are not considered adverse, the FDA spokesperson reiterated.

So far, the spokesperson continued, Safety data from clinical trials of approved weight loss drugs have not demonstrated adverse effects . . . such as increased incidence of falls, or muscle or tendon injuries, that would be related to loss of lean body mass. Nor have patient-reported outcomes.

But if they arent included among the endpoints, are they being tracked?

The next wave of innovation will be around muscle preservation, Mamtani predicted.

Measuring changes in lean mass is critical for assessing the quality of weight loss, Harris stressed.At Altimmune, we believe the quality of weight loss is as important as the quantity. Thus, we took steps to incorporate this into MOMENTUM, our recently completed Phase II obesity trial.

Additionally, Mamtani called for endpoints to measure weight regain and physical function. Currently, almost two-thirds of the weight lost comes back when patients quit GLP-1 therapies. Likewise, he continued, If youve gone from 250 to 200 pounds, has your quality of life improved?

Several biopharmaceutical companies are building such additional endpoints into their clinical trials for GLP-1 combination therapies.

For example, the percentage change in lean body mass after 112 days is the primary endpoint for Verus Phase II dose-finding study of enobosarm, which conserves muscle mass, combined with GLP-1 receptor agonist semaglutide for weight loss.A series of late-stage trials for enobosarm alone indicates significant improvements in muscle mass compared to placebo.

At Regeneron, a small Phase II study for trevogrumab, which builds muscle mass, was enrolling in March. It will be followed by a larger, four-arm study mid-year to compare outcomes for the combination of trevogrumab and semaglutide. That combination will then be compared to outcomes with or without garetosmab, also developed by Regeneron, which preserves muscle. Primary endpoints include the percent change in both total fat mass and body weight. Secondary endpoints include changes in body weight, lean mass, waist circumference and the total lean mass to fat ratio.

Part C of that trial will evaluate patients weight maintenance and function. Once patients cease taking semaglutide, Roughly half will continue on high-dose trevogrumab to see if the weight can stay off, Ryan Crowe, senior vice president of investor relations and strategic analysis at Regeneron, said at the Barclays Global Healthcare Conference in March. Regeneron did not respond to BioSpaces requests for updates. Qualitative endpoints will include how well people can complete day-to-day tasks, such as a stand-and-sit test, he added. That will probably inform what we do next in terms of measuring functional muscle.

AsMamtani put it, Its the Wild West right now for obesity drugs, and having all this clinical data is going to be important. The future of weight loss drugs may not depend on having the best GLP-1 receptor agonist, he said, but rather a combination of therapeutics that cause weight loss while building or conserving muscle or that improve metabolic health or maintain weight loss.

Almost every serious company in this space is trying to work on that shift, Mamtani said.

Gail Dutton is a freelance science writer who has covered the biopharma industry since soon after its inception. She can be reached at gaildutton@gmail.com. Follow her on LinkedIn or see more of her work on MuckRack.

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Measuring Muscle Loss in the Wild West of Weight Loss Drugs - BioSpace

Sorry, Ozempic users.

Bariatric surgery leads to more weight loss that lasts longer, compared to drugs like Ozempic and Wegovy and behavioral changes such as diet and exercise, new research finds.

Metabolic and bariatric surgery remains the most effective and durable treatment for severe obesity. Unfortunately, it also remains among the most underutilized, said study co-author and bariatric surgeon Dr. Marina Kurian of NYU Langone Health.

Researchers reviewed data from approximately 20,000 weight-loss patients who participated in clinical studies and trials in the last few years.

They found that obesity drugs and weight-loss surgery proved far superior to diet and exercise, which resulted in an average weight loss of 7.4% those pounds were typically regained within four years.

Five months of weekly injections of semaglutide the active ingredient in Ozempic and Wegovy led to a weight loss of 10.6%. These drugs mimic GLP-1 the hormone the body naturally produces after eating to make people feel full, reducing their cravings.

Nine months of tirzepatide sold under the brand names Mounjaro and Zepbound produced weight loss of 21.1%.

But the researchers found that once these treatments stopped, within a year, patients regained about half the weight they had lost.

Tirzepatide patients who continued with the injections tended to plateau at 17 to 18 months with 22.5% of their weight lost. Patients on semaglutide hit a roadblock at 14.9% weight loss during the same period.

Two popular surgical procedures, meanwhile, produced a weight loss around 30% one year after the operation. Patients maintained a 25% weight loss up to 10 years after surgery, the researchers found.

Surgery needs to play a bigger role in obesity treatment and be considered earlier in the disease process, Kurian added. It is no longer a treatment of last resort and should not be withheld until more severe disease develops. There is no medical reason for this.

The research was presented Tuesday at the American Society for Metabolic and Bariatric Surgery 2024 Annual Scientific Meeting.

The society reports that nearly 280,000 weight-loss procedures were performed in the US in 2022, representing only about 1% of those who are eligible for them based on their weight and height.

Gastric bypass and sleeve gastrectomy are two types of weight-loss surgeries that reduce the size of the stomach. Some people may be hesitant to opt for surgery because recovery can take weeks.

There are potential drawbacks to obesity meds as well, including various unpleasant side effects. In a July 2023 survey, 4% of adults admitted to taking a prescription drug to lose weight.

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All the while, obesity rates continue to rise, affectingmore than 42% of Americans, according to the Centers for Disease Control and Prevention.

The serious condition has been shown to weaken the bodys immune system, cause chronic inflammation and increase the risk of cardiovascular disease, stroke, Type 2 diabetes and certain cancers.

A recent study warned that uncontrolled high blood pressure, diabetes and obesity will lead to at least six in 10 US adults being diagnosed with cardiovascular disease within the next 30 years.

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Weight loss surgery more effective than obesity drugs: study - New York Post

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