High-Dose Wegovy Wins FDA Approval

The FDA approved a higher dose of the GLP-1 receptor agonist semaglutide for weight loss, dubbed Wegovy HD, the agency announced on Thursday.

The once-weekly injectable will come in a 7.2-mg dose — three times the strength of the existing 2.4-mg Wegovy. It is indicated alongside a low-calorie diet and increased physical activity in adults with obesity who have tolerated the 2.4-mg dose for at least 4 weeks and still need to lose more weight.

Injectable semaglutide is also indicated to reduce the risk of major adverse cardiovascular events and to treat metabolic dysfunction-associated steatohepatitis (MASH).

“Wegovy HD represents an important new tool in obesity management, allowing clinicians to better tailor treatment strategies and help improve outcomes,” said STEP UP investigator W. Timothy Garvey, MD, of the Diabetes Research Center at the University of Alabama at Birmingham, in a press release. “The weight loss demonstrated with Wegovy HD could reshape healthcare professionals’ expectations about what outcomes are possible for their patients with Wegovy.”

In the 72-week STEP UP trial, adults without type 2 diabetes who received semaglutide 7.2 mg lost an average 19% of their body weight, regardless of treatment adherence. Participants on the 2.4-mg dose and placebo lost 16% and 3.9% of their body weight, respectively.

Those who remained adherent to 7.2-mg semaglutide lost 21% of their body weight, and 31% lost at least a quarter of their body weight.

The most common adverse reactions reported included nausea, vomiting, dysesthesia, constipation, abdominal pain, fatigue, headache, dizziness, hair loss, and flatulence. Dysesthesia occurred at a higher rate with the 7.2-mg dose compared with the 2.4-mg dose.

Additionally, 22% of those on the 7.2-mg dose experienced events related to altered skin sensation — such as sensitive skin, hyperesthesia, dysesthesia, and paresthesia — compared with 6% of those who received 2.4 mg and virtually none in the placebo group. The FDA said it is currently conducting further investigations into this drug reaction.

The label carries a boxed warning regarding the potential risk of thyroid C-cell tumors. It’s also contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2.

In addition to the injectable, semaglutide for weight loss is also available as a once-daily 25-mg pill, which was approved in December 2025.

Wegovy HD’s approval was granted within 54 days of filing, marking the fourth approval under the FDA Commissioner’s National Priority Voucher pilot program.

Novo Nordisk said Wegovy HD will be available starting in April.