Yes, Wegovy is FDA approved for weight loss. The FDA approved it in June 2021 specifically for chronic weight management in adults with obesity or overweight. Since then, its approved uses have expanded to include adolescents and cardiovascular risk reduction.
Who Qualifies for Wegovy
The FDA approved Wegovy for adults with a BMI of 30 or greater (obesity) or a BMI of 27 or greater (overweight) who also have at least one weight-related health condition such as high blood pressure, type 2 diabetes, or high cholesterol. It’s approved as a companion to a reduced-calorie diet and increased physical activity, not as a standalone treatment.
In December 2022, the FDA extended approval to adolescents aged 12 and older whose BMI falls at or above the 95th percentile for their age and sex. This made Wegovy one of the first GLP-1 medications approved for pediatric obesity.
How Wegovy Works
Wegovy’s active ingredient is semaglutide, which mimics a hormone your body naturally produces after eating. This hormone signals fullness to your brain, slows how quickly food leaves your stomach, and reduces appetite. The net effect is that you feel satisfied with less food.
It’s given as a once-weekly injection under the skin, typically in the abdomen, thigh, or upper arm. The dose starts low at 0.25 mg per week and increases gradually over 16 weeks to reduce the chance of stomach-related side effects. By week 17, adults reach the maintenance dose of 2.4 mg weekly (or 1.7 mg if the higher dose isn’t tolerated). Adolescents stay at the 2.4 mg dose.
Weight Loss in Clinical Trials
The FDA based its approval largely on the STEP trial program. The pivotal study enrolled nearly 2,000 adults with obesity or overweight (plus at least one related health condition) and tracked them over 68 weeks, roughly a year and a half. Participants taking Wegovy alongside diet and exercise changes lost significantly more weight than those receiving a placebo. Most of the weight loss occurred during the first 60 weeks, with results plateauing after that point.
Weight tends to return after stopping the medication. This is why the FDA approval specifies “chronic weight management,” signaling that Wegovy is intended as a long-term treatment rather than a short course.
The 2024 Heart Health Approval
In March 2024, the FDA approved a second major use for Wegovy: reducing the risk of heart attack, stroke, and cardiovascular death in adults who have established heart disease and either obesity or overweight. This made Wegovy the first weight-loss drug ever approved specifically for heart protection in this population.
The approval came from a trial of more than 17,600 participants. Among those taking Wegovy, 6.5% experienced a major cardiovascular event compared to 8% in the placebo group. That’s a meaningful reduction in absolute terms, particularly for people already at elevated heart risk due to both cardiovascular disease and excess weight.
How Wegovy Differs From Ozempic
Both Wegovy and Ozempic contain semaglutide, but the FDA approved them for different purposes. Ozempic is approved for managing type 2 diabetes and reducing cardiovascular risk in people with type 2 diabetes and heart disease or chronic kidney disease. It is not FDA approved for weight loss. Wegovy is approved for weight management, cardiovascular risk reduction in people with obesity or overweight, and treatment of a specific liver condition called MASH with moderate or advanced scarring.
Wegovy also comes in a higher maximum dose: 2.4 mg per week compared to Ozempic’s 2 mg cap. The higher dose is part of what drives greater weight loss results, and it’s a key reason why the two medications aren’t considered interchangeable despite sharing the same active ingredient.
Side Effects to Expect
The most common side effects are gastrointestinal: nausea, diarrhea, vomiting, and constipation. These tend to be worst during the dose escalation period, which is exactly why the dose ramps up slowly over four months. Most people find the side effects manageable and often improving once the body adjusts to a stable dose.
Wegovy carries a boxed warning, the FDA’s most serious label alert, about thyroid tumors. In animal studies, semaglutide caused thyroid tumors in rodents. It’s unknown whether this translates to humans, but Wegovy should not be used by anyone with a personal or family history of a type of thyroid cancer called medullary thyroid carcinoma or a rare condition called Multiple Endocrine Neoplasia syndrome type 2.
Current Availability
Wegovy was on the FDA’s drug shortage list from 2022 through early 2025 due to surging demand. The FDA officially declared the shortage resolved in February 2025, and as of early 2026, semaglutide injection products no longer appear on the shortage list. All dose strengths are currently available from the manufacturer, though insurance coverage and cost remain significant barriers for many patients. The list price runs over $1,300 per month without insurance, though manufacturer savings programs and insurance plans can lower out-of-pocket costs substantially.