The FDA has approved a higher 7.2 mg dose of Novo Nordisk’s Wegovy (Wegovy HD) for chronic weight management in adults with obesity.
The new dose showed greater weight loss in a large clinical trial compared with both placebo and the existing 2.4 mg dose.
Wegovy remains the only GLP-1 weight-loss drug also proven to reduce major cardiovascular risks such as heart attack and stroke in certain patients.
The U.S. Food and Drug Administration has given a green light to a higher-dose version of Novo Nordisk’s weight loss drug Wegovy, to help obese patients shed pounds at a faster rate.
The newly approved formulation, Wegovy HD (semaglutide) injection 7.2 mg, is intended for adults with obesity who have already tried the currently available 2.4 mg dose and require additional weight reduction. The medication is not a standalone tool, but is to be used with a reduced-calorie diet and increased physical activity.
The approval is based on results from the STEP UP clinical trial program, including a 72-week study involving 1,407 adults with obesity but without diabetes. Participants receiving the 7.2 mg dose achieved greater weight loss compared with those taking the 2.4 mg dose or a placebo.
“This milestone expands the strong clinical profile of Wegovy,” said Jamey Millar, executive vice president of U.S. operations at Novo Nordisk. He added that no other weight-loss medication has demonstrated superiority over Wegovy HD in clinical studies.
Previous dose limited to 2.4 mg
Until now, the highest approved dose of Wegovy for weight loss was 2.4 mg. That dose also carries an additional indication: reducing the risk of major cardiovascular events — including heart attack, stroke, or death — in adults with obesity or overweight who have established heart disease. Novo Nordisk emphasized that this dual benefit remains unique among GLP-1 drugs for weight management.
The use of GLP-1 drugs has dramatically increased in the last 12 months. Medical experts say the higher dose could reshape expectations for obesity treatment.
Side effects
Like other GLP-1 therapies, Wegovy HD carries side effects. The most commonly reported include nausea, vomiting, constipation, abdominal pain, fatigue, headaches, and dizziness.
The higher dose was also associated with a greater incidence of altered skin sensations — such as tingling or sensitivity — reported in about 22% of patients, compared with 6% for the 2.4 mg dose and less than 1% for placebo.
Novo Nordisk said Wegovy HD will be available starting in April through more than 70,000 U.S. pharmacies, as well as telehealth providers and its NovoCare pharmacy service. Pricing, insurance coverage, and savings programs for eligible patients are expected to be announced at launch.
The approval comes as demand for GLP-1 weight-loss drugs continues to surge, intensifying competition among drugmakers racing to develop more effective obesity treatments.