Diabetes Drugs For Weight Loss – FDA approves anti-obesity drug that helped some people lose 15% of weight In studies funded by the company, participants who took Novo Nordisk Wegovy lost an average of about 34 pounds. In the comparison group that received sham injections, the average loss was less than 6 pounds.
This image, provided by Novo Nordisk, shows a package of the company’s semaglutide drug, called Wegovy. On Friday, the FDA announced that this new version of a popular diabetes drug could be marketed as a weight loss drug. Cristian Mihaila/AP hide caption
Diabetes Drugs For Weight Loss
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This image, provided by Novo Nordisk, shows a package of the company’s semaglutide drug, called Wegovy. On Friday, the FDA announced that this new version of a popular diabetes drug could be marketed as a weight loss drug.
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A new version of a popular diabetes drug could be sold as a weight-loss drug in the U.S., regulators said Friday.
The Food and Drug Administration has approved Wegovy, a higher-dose version of Novo Nordisk’s diabetes drug semaglutide, for long-term weight management.
In studies funded by the company, participants who took Wegovy lost an average of 15% of their weight, about 34 pounds (15.3 kilograms). Participants lost weight steadily for 16 months before reaching a plateau. In the comparison group that received sham injections, the average weight loss was about 2.5%, or just under 6 pounds.
“With existing drugs, you’ll achieve maybe a 5 to 10 percent reduction in body weight, sometimes not even that much,” said Dr. Harold Bays, medical director of the Louisville Metabolic and Atherosclerosis Research Center. Bays, who is also the chief scientific officer of the Association for Obesity Medicine, helped lead studies of the drug.
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Losing even 5% of body weight can bring health benefits, such as improved energy, blood pressure, blood sugar and cholesterol levels, but that amount often doesn’t satisfy patients focused on weight loss, Bays said.
Bays said Wegovy appears to be much safer than previous obesity drugs that have “fired” due to safety concerns. The most common side effects of Wegovy were gastrointestinal problems, including nausea, diarrhea and vomiting. They usually subsided, but about 5% of study participants stopped taking the drug.
The drug poses a potential risk for a type of thyroid tumor, so it should not be taken by people with a personal or family history of certain thyroid tumors and endocrine tumors. Wegovy also has a risk of depression and inflammation of the pancreas.
Wegovy (pronounced wee-GOH’-vee) is a synthesized version of a gut hormone that suppresses appetite. Patients inject it weekly under the skin. Like other weight loss medications, it should be used along with exercise, a healthy diet, and other steps like keeping a food diary.
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The Danish company did not disclose Wegovy’s price, but said it would be similar to Saxenda, an 11-year-old weight-loss drug that is injected daily and now typically costs more than $1,300 a month without insurance.
Dr. Archana Sudhu, director of the diabetes program at Houston Methodist Hospital, said Wegovy’s utility “all depends on what the price is going to be.” She noted that patients’ health insurance plans sometimes don’t cover weight-loss treatments, putting expensive drugs out of reach.
Sudhu, which is not affiliated with Novo Nordisk, plans to switch patients who are obese and have type 2 diabetes to Wegovy. This makes patients feel full sooner and increases the release of insulin from the pancreas to control blood sugar, she said. Patients would then be more likely to be motivated to exercise and eat healthier, she added.
Wegovy builds on a trend in which makers of relatively new diabetes drugs are testing drugs to treat other conditions common to diabetics. For example, the popular diabetes drugs Jardiance and Novo Nordisk’s Victoza are now approved to reduce the risk of heart attack, stroke and death in heart patients.
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Phylander Pannell, 49, of Largo, Maryland, joined the study of patients after cycles of losing and then regaining weight. She said she took Wegovy, exercised several times a week and lost 65 pounds in 16 months.
“It helped reduce my appetite and made me feel full faster,” Pannell said. “It set me on the right path.”
Shortly after she finished the study and stopped receiving Wegovy, she regained about half her weight. She has since lost a lot of it, started working out and bought home exercise equipment. He is considering returning to Wegovy after it is approved. Another Weight Loss Trial Win for Weekly GLP-1 Drug – Effective in Diabetics with BMIs up to 27
When combined with lifestyle control, once-weekly semaglutide (Ozempic) produced significant weight loss in overweight adults with type 2 diabetes, the Effect of Semaglutide Treatment in People with Obesity (STEP) 2 study, sponsored by manufacturer.
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In trial III. superiority phase in more than 1,200 adults with a body mass index (BMI) of at least 27, those taking 2.4 mg subcutaneous semaglutide weekly lost an average of 9.6% of baseline body weight after 68 weeks of treatment, compared with 3.4% . % for those taking only placebo and lifestyle intervention (treatment difference -6.2 percentage points, 95% CI -7.3 to -5.2,
The study, published online in The Lancet, also included a third group of patients who received 1.0 mg of semaglutide once a week – a dose already approved for type 2 diabetes (such as a 0.5 mg dose). After 68 weeks of treatment, this group had an average reduction in baseline body weight of 7%.
By week 68, patients taking semaglutide 2.4 mg weekly were almost five times more likely to achieve at least a 5% reduction in body weight compared with placebo (OR 4.88, 95% CI 3.58- 6.64,
Overall, about 69% of those who took 2.4 mg of semaglutide were able to lose at least 5% of their baseline body weight—which met the trial’s other co-primary endpoint—compared to only 29% of those who took the lifestyle intervention alone . About 57% of those receiving the 1 mg dose achieved at least a 5% reduction in body weight.
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In addition to weight loss benefits, those taking 2.4 mg of semaglutide also saw significant improvements in waist circumference, systolic blood pressure, lipid profile, inflammatory markers and physical function, the researchers reported.
In addition, and unsurprisingly, significant improvements were also seen in blood glucose, with 68% of those taking the higher dose achieving an HbA1c of 6.5% or less, while 79% managed to achieve a value below 7 %.
These findings are based on the recently reported STEP 1 trial, which tested semaglutide in a population of adults with obesity (BMI 30+) but without type 2 diabetes.
In this similar 68-week trial, adults who took 2.4 mg of semaglutide weekly lost an average of 14.9% of their baseline body weight, compared with only 2.4% in those who received only placebo and lifestyle intervention (treatment difference -12.4%, 95% CI -13.4 to -11.5,
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“This is the first trial to show that in overweight or obese adults with type 2 diabetes, subcutaneous semaglutide at a dose of 2.4 mg once weekly produces clinically significant weight reduction,” Lingvay’s group wrote. “The magnitude of weight loss achieved with semaglutide 2.4 mg in STEP 2 was greater than that seen with liraglutide and other approved antiobesity agents in similar patient populations.”
Liraglutide (Saxenda) was approved in December 2014 at a dose of 3 mg/day for chronic weight management in adults with a BMI of 30 or greater or a BMI of 27 or greater and at least one weight-related medical condition.
In an accompanying commentary, Roberto Latini, MD, and Lidia Staszewsky, MD, both of the Mario Negri IRCCS Institute for Pharmacological Research in Milan, Italy, pointed out that two major advantages of semaglutide are its once-weekly dosing — rather than once-daily with liraglutide — and a stronger effect on weight loss.
The STEP 2 trial enrolled 1,210 adults from 149 clinics across North America, Europe, South America, the Middle East, South Africa, and Asia. To be included, all participants had to have a BMI of at least 27 and an HbA1c of 7-10% with a diagnosis of type 2 diabetes at least 180 days prior to screening.
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However, patients on insulin were excluded, which Latini and Staszewsky called “an issue that should be considered in future studies, given the widespread use of insulin.”
Participants were randomized 1:1:1 — 404 received 2.4 mg semaglutide, 403 received 1 mg semaglutide, and 403 received placebo.
Treatment was initiated at a dose of 0.25 mg per week and titrated in a fixed-dose regimen every 4 weeks until the target dose was reached. All participants also underwent a lifestyle intervention that included 150 minutes of physical exercise per week and a 500 kcal deficit per day.
Adverse events in the STEP clinical program were generally consistent with those previously observed with other GLP-1 receptor agonists, with gastrointestinal adverse events being the most common.
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About 64% of those taking the higher dose of semaglutide experienced gastrointestinal side effects, including nausea, vomiting, diarrhea, and constipation, which were mostly mild to moderate. Approximately one-third of patients taking 1 mg of semaglutide experienced gastrointestinal side effects.
In December 2020, Novo Nordisk submitted a US marketing authorization application under the STEP program for semaglutide 2.4 mg for chronic weight management in adults with obesity or overweight and at least one weight-related comorbidity.
Source reference: Davies M, et al. “Semaglutide 2.4 mg once weekly in overweight or obese adults with type 2 diabetes (STEP 2): a randomized, double-blind, double-blind trial,
