From the Guidelines
No, Ozempic (semaglutide) is not FDA approved specifically for weight loss, but a different formulation of semaglutide called Wegovy is FDA approved for chronic weight management in adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related condition. Ozempic is FDA approved for the treatment of type 2 diabetes. According to the most recent study 1, semaglutide works by mimicking a hormone called GLP-1 that targets areas of the brain that regulate appetite and food intake, helping people feel fuller longer and consume fewer calories. The study also highlights that subcutaneous semaglutide was FDA approved to treat obesity in 2021 and is dosed once weekly.
Some key points to consider when prescribing semaglutide for weight loss include:
- The medication should be used in conjunction with a reduced-calorie diet and increased physical activity 1
- The majority of studies incorporated lifestyle intervention of a hypocaloric diet (500-kcal daily deficit) along with 150 minutes of physical activity per week 1
- Common side effects include nausea, vomiting, diarrhea, and constipation 1
- The medication should be used with caution in patients with a history of pancreatitis, cholelithiasis, or medullary thyroid cancer 1
It's also important to note that while some healthcare providers may prescribe Ozempic "off-label" for weight loss, this use is not officially approved by the FDA. However, the FDA-approved formulation of semaglutide, Wegovy, contains the same active ingredient as Ozempic but at a higher maximum dose (2.4 mg versus 2 mg for Ozempic) and is specifically indicated for weight management 1.
From the Research
Ozempic FDA Approval for Weight Loss
- Ozempic, also known as semaglutide, is a glucagon-like peptide-1 (GLP-1) receptor agonist that has been approved by the FDA for the treatment of type 2 diabetes 2, 3.
- While Ozempic has been shown to be effective in promoting weight loss in patients with type 2 diabetes, its FDA approval is specifically for the treatment of type 2 diabetes, not for weight loss alone 2, 3.
- However, a systematic review and meta-analysis of semaglutide for type 2 diabetes mellitus found that semaglutide had a beneficial effect on body weight, with a mean difference vs placebo of -4.11 kg 2.
- Another study compared the effectiveness of semaglutide, liraglutide, orlistat, and phentermine for weight loss in obese individuals and found that semaglutide was effective in managing weight loss among obese individuals 4.
- It's worth noting that the FDA has approved a higher-dose version of semaglutide, called Wegovy, specifically for the treatment of obesity in adults with a body mass index (BMI) of 30 or higher, or adults with a BMI of 27 or higher who have at least one weight-related condition 4.
Key Findings
- Semaglutide has been shown to be effective in promoting weight loss in patients with type 2 diabetes 2, 3.
- Semaglutide has a beneficial effect on body weight, with a mean difference vs placebo of -4.11 kg 2.
- The FDA has approved a higher-dose version of semaglutide, called Wegovy, specifically for the treatment of obesity in adults 4.
Studies
- A systematic review and meta-analysis of semaglutide for type 2 diabetes mellitus found that semaglutide had a beneficial effect on body weight 2.
- A study comparing the effectiveness of semaglutide, liraglutide, orlistat, and phentermine for weight loss in obese individuals found that semaglutide was effective in managing weight loss among obese individuals 4.
- A multicentre, prospective, randomized, open-label, parallel-group comparison study found that switching from liraglutide or dulaglutide to once-weekly semaglutide improved glycaemic control and treatment satisfaction in patients with type 2 diabetes 5.