From the Guidelines
Semaglutide is FDA approved for the treatment of obesity in adults, as evidenced by its approval in 2021 for this indication. The FDA approval of semaglutide for obesity management is supported by the results of the STEP trials, which demonstrated significant weight loss in individuals with obesity without diabetes, with a mean weight loss of 14.9% and 16.0% in the STEP 1 and STEP 3 trials, respectively, compared to 2.4% and 5.7% with placebo 1. The dosing for semaglutide in this context is once weekly, with a maintenance dose of 2.4 mg. It's worth noting that semaglutide is also FDA approved for other indications, including type 2 diabetes, under different brand names and formulations.
Some key points to consider when prescribing semaglutide for obesity management include:
- The importance of combining semaglutide with lifestyle modifications, such as a reduced-calorie diet and increased physical activity, to achieve optimal weight loss results
- The need for long-term use of semaglutide to maintain weight loss, as evidenced by the significant weight regain observed after cessation of treatment in the STEP trials 1
- The potential benefits of semaglutide in reducing the risk of cardiovascular events in adults with overweight or obesity without diabetes, as demonstrated in a meta-analysis and the SELECT study 1
Overall, semaglutide is a valuable treatment option for adults with obesity, offering significant weight loss and potential cardiovascular benefits when used in conjunction with lifestyle modifications. The most recent and highest quality evidence supports the use of semaglutide for obesity management, with the STEP trials providing strong evidence for its efficacy and safety in this population 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Semaglutide FDA Approval
- Semaglutide, a GLP-1 receptor agonist, has been approved by the FDA for the treatment of type 2 diabetes and for chronic weight management 2.
- The FDA approval of semaglutide for weight loss is based on the results of clinical trials, including the STEP trial, which demonstrated the efficacy of semaglutide in reducing body weight in patients with obesity 2.
- Semaglutide is marketed under the brand name Ozempic for the treatment of type 2 diabetes and under the brand name Wegovy for chronic weight management 2.
- The FDA approval of semaglutide is also supported by studies that have shown its efficacy in improving glycemic control and reducing body weight in patients with type 2 diabetes 3, 4, 5, 6.
Indications and Usage
- Semaglutide is indicated for the treatment of type 2 diabetes in adults as an adjunct to diet and exercise 3, 4, 5, 6.
- Semaglutide is also indicated for chronic weight management in adults with obesity or overweight with at least one weight-related condition 2.
- The recommended dose of semaglutide for type 2 diabetes is 0.5 mg or 1 mg injected subcutaneously once weekly 3, 4, 5, 6.
- The recommended dose of semaglutide for chronic weight management is 2.4 mg injected subcutaneously once weekly 2.
Safety and Efficacy
- Semaglutide has been shown to be effective in improving glycemic control and reducing body weight in patients with type 2 diabetes 3, 4, 5, 6.
- Semaglutide has also been shown to be effective in reducing body weight in patients with obesity or overweight 2.
- The most common adverse reactions associated with semaglutide include nausea, vomiting, diarrhea, and abdominal pain 3, 4, 5, 6.