FDA Approves Higher Dose Semaglutide (Wegovy HD) Injection 7.2 mg for Obesity

The US Food and Drug Administration (FDA) has approved a new higher dose of Novo Nordisk’s semaglutide (Wegovy; Wegovy HD) injection 7.2 mg to be used along with a reduced calorie diet and increased physical activity to help adults with obesity lose weight and keep it off, provided they have tolerated the 2.4 mg dosage for ≥ 4 weeks and additional weight reduction is clinically indicated.1

As described in a March 19, 2026, press release from the Company, the approval is based on the results from the STEP UP trial program. Of note, the new update supplements the existing semaglutide label, which also has distinct indications for semaglutide not offered by any other GLP-1 medication for weight loss.

"Wegovy® HD represents an important new tool in obesity management, allowing clinicians to better tailor treatment strategies and help improve outcomes," W Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham, said in a statement. "The weight loss demonstrated with Wegovy® HD could reshape healthcare professionals' expectations about what outcomes are possible for their patients with Wegovy®."

The FDA initially approved semaglutide 2.4 mg in June 2021 for chronic weight management in adults with obesity or overweight, marking a landmark approval for the GLP-1 RA class. A label expansion in March 2024 added an indication for reduction of cardiovascular risk among adults with obesity or overweight, based on results from the SELECT trial.

Prior to the approval of Wegovy HD, the highest approved dose of semaglutide injectable for weight loss was 2.4 mg, which is also indicated, along with a reduced calorie diet and increased physical activity, to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.

The newest approval is based on the results of the STEP UP trial program. STEP UP was a phase 3b 72-week randomized, double-blinded, placebo-controlled and active-controlled superiority trial designed to evaluate the efficacy and safety of semaglutide injection 7.2 mg compared to semaglutide injection 2.4 mg and placebo as an adjunct to lifestyle intervention. A total of 1407 adults with BMI ≥30 kg/m2 without diabetes were included in the trial.

The primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss after 72 weeks with respect to the percentage change in body weight and the proportion of participants achieving weight loss of ≥ 5%. Select confirmatory secondary endpoints included number of participants achieving ≥10%, 15%, 20% and 25% weight loss, with semaglutide 7.2 mg vs placebo (and for ≥ 20% and 25%, semaglutide 7.2 mg vs semaglutide 2.4 mg).

In total, 1407 participants were randomly assigned in a 5:1:1 ratio to receive once-weekly subcutaneous semaglutide 7.2 mg, 2.4 mg, or placebo, alongside lifestyle intervention, for 72 weeks.

Topline results from the trial were announced in January 2025 and showed statistically significant and superior weight loss at 72 weeks with semaglutide 7.2 mg, compared with placebo, irrespective of treatment adherence.2

As described in the release from Novo Nordisk, for those taking Wegovy HD, 89% achieved ≥ 5% body weight loss versus 38% taking placebo (from a baseline body weight of 248 lbs).

The most common adverse reactions reported with Wegovy HD were nausea, vomiting, dysesthesia, constipation, abdominal pain, fatigue, headache, dizziness, hair loss and flatulence. In clinical trials, dysesthesia was reported at a higher rate with Wegovy HD compared to semaglutide 2.4 mg and placebo.

Events related to a clinical picture of altered skin sensation such as sensitive skin, hyperesthesia, dysesthesia and paresthesia were reported by a greater proportion of participants, and at a higher rate, in the Wegovy HD arm (22%), compared to treatment with semaglutide 2.4 mg (6%) and placebo (0.3%).

As described in the press release from Novo Nordisk, Wegovy HD will be available in April through all channels where patients can access semaglutide, including 70,000 plus pharmacies in the US like CVS and Costco, select telehealth providers, NovoCare Pharmacy, GoodRx, and others.

"We are excited to bring Wegovy® HD injection to adults with obesity who are looking for powerful weight loss, as no other weight loss medicine has been studied to show superiority to Wegovy® HD," said Jamey Millar, executive vice president, US Operations of Novo Nordisk. "In addition to significant weight loss, Wegovy® is the only GLP-1 for adults with obesity that is proven to reduce the risk of events such as stroke, heart attack, or cardiovascular death in those who also have known heart disease. Today's milestone expands the strong clinical profile of Wegovy® that includes multiple indications that no other GLP-1 for weight loss can claim."

References

1. Novo Nordisk. FDA approves Novo Nordisk's new Wegovy® HD injection, delivering the highest weight loss to date for a Wegovy® injection, adding to its already expansive clinical profile. March 19, 2026. Accessed March 19, 2026. https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-new-wegovy-hd-injection-delivering-the-highest-weight-loss-to-date-for-a-wegovy-injection-adding-to-its-already-expansive-clinical-profile-302718982.html

2. Iapoce C. Semaglutide 7.2 mg Displays 20.7% Weight Loss in Phase 3b STEP UP Trial. HCPLive. January 17, 2025. Accessed March 19, 2026. https://www.hcplive.com/view/semaglutide-7-2-mg-displays-20-7-weight-loss-in-phase-3b-step-up-trial