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The FDA has approved a new higher-dose version of injectable semaglutide (Wegovy HD, Novo Nordisk) for both weight loss and long-term weight-loss maintenance.
The higher dose, 7.2 mg, produced an average weight loss of 21% in adults with obesity who stayed on the drug for 72 weeks and 19% overall in the STEP UP trial
of 1407 adults with BMI of ≥ 30 without diabetes. Corresponding reductions with placebo were just 2% and 4%, respectively.
Weight loss of at least 25% was achieved by 31.2% with the 7.2 mg dose vs 15.3% with 2.4 mg and 0% with placebo.
The higher-dose version is indicated for use along with a reduced calorie diet and increased physical activity in people with obesity who have tolerated the 2.4 mg dose for at least 4 weeks and require further weight loss.
The most common adverse reactions were nausea, vomiting, dysesthesia, constipation, abdominal pain, fatigue, headache, and dizziness. Altered skin sensations were reported by 22% with the 7.2 mg dose vs 6% with semaglutide 2.4 mg and 0.3% placebo.
The approval was granted 54 days after Novo Nordisk’s filing as part of the new FDA commissioner’s National Priority Voucher pilot program, aimed at expediting approval of “applications that address critical national health priorities,” according to an FDA statement. It is the fourth drug approved as part of that program.
Wegovy HD will be available in US pharmacies and pharmacy programs in April 2026, Novo Nordisk said in a statement.
Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker and BlueSky @miriametucker.bsky.social
