Yes, semaglutide is FDA approved for weight loss, but only under the brand name Wegovy. It was first approved for chronic weight management in June 2021, and it remains the only semaglutide product with that specific approval. The other well-known brand, Ozempic, contains the same active ingredient but is approved only for type 2 diabetes and related conditions.
Wegovy Is the FDA-Approved Version for Weight Loss
Wegovy and Ozempic are both semaglutide, a once-weekly injection that mimics a natural gut hormone called GLP-1. This hormone slows digestion, reduces appetite, and signals fullness to the brain. The two products differ in their approved uses and their maximum doses.
Wegovy is approved at a maximum dose of 2.4 mg per week specifically for weight management. Ozempic tops out at 2 mg and is labeled for managing type 2 diabetes, improving kidney health in people with diabetes and chronic kidney disease, and reducing cardiovascular risk in adults with diabetes and heart disease. Doctors sometimes prescribe Ozempic off-label for weight loss, but that use isn’t part of its official FDA indication.
Who Qualifies for a Prescription
The FDA approved Wegovy for use alongside a reduced-calorie diet and increased physical activity in two groups: adults and children aged 12 and older with obesity (generally a BMI of 30 or higher), and adults with overweight (BMI of 27 or higher) who also have at least one weight-related health condition such as high blood pressure, type 2 diabetes, or high cholesterol.
How Much Weight People Typically Lose
In clinical trials, participants taking the 2.4 mg dose lost significantly more weight than those on a placebo. One large trial in people with obesity and prediabetes found an average body weight reduction of 13.9% over 52 weeks, compared to 2.7% in the placebo group. That translates to roughly an 11-percentage-point difference attributable to the medication itself. For someone weighing 220 pounds, that would mean losing about 30 pounds in a year on semaglutide versus about 6 pounds on placebo.
Results vary from person to person. Some people lose more, some less. The drug works best when paired with dietary changes and regular physical activity, which is why the FDA label specifies those lifestyle components as part of the treatment.
Beyond Weight Loss: Heart Protection
In March 2024, the FDA expanded Wegovy’s approved uses to include reducing the risk of cardiovascular death, heart attack, and stroke in adults who have established heart disease along with obesity or overweight. This made Wegovy the first weight management drug approved specifically for heart protection in this population.
The approval was based on a trial of more than 17,600 participants. Major cardiovascular events occurred in 6.5% of those taking Wegovy compared to 8% in the placebo group. That 1.5-percentage-point difference represents a meaningful reduction in serious, life-threatening events over the study period.
How the Dosing Works
Wegovy isn’t started at full strength. The dose is gradually increased over about 16 to 20 weeks to help your body adjust and reduce side effects. You begin with a low weekly dose and step up every four weeks until reaching the maintenance dose of 2.4 mg per week. Each dose is a single injection you give yourself under the skin of the abdomen, thigh, or upper arm using a pre-filled pen.
Common Side Effects
Gastrointestinal symptoms are by far the most frequent complaints. In clinical trials, 44% of people taking Wegovy experienced nausea, 30% had diarrhea, 24% reported vomiting, 24% had constipation, and 20% experienced abdominal pain. Headache affected about 14% of participants. These side effects tend to be most noticeable during the dose escalation period and often improve as the body adjusts.
The gradual titration schedule exists specifically to ease this transition. Starting at the full 2.4 mg dose would likely cause more severe nausea and vomiting. Most people find the side effects manageable, but for some they’re significant enough to require a slower dose increase or, occasionally, discontinuation.
Supply and Availability
Semaglutide products experienced widespread shortages starting in 2022 as demand surged. During that period, compounding pharmacies stepped in to produce custom versions of semaglutide. As of early 2026, semaglutide no longer appears on the FDA’s official drug shortage list, and the agency has noted that the national supply of GLP-1 medications has begun to stabilize. This means the brand-name products are generally available through standard pharmacies, though cost and insurance coverage remain significant barriers for many people.