FDA
FDA OK's higher dose Wegovy injection for weight loss
On March 19, 2026, FDA approved Wegovy HD (semaglutide), a high dose (7.2 mg), once-weekly injectable formulation, indicated to reduce excess body weight and maintain weight reduction long-term in adults who are obese or overweight with at least one weight-related comorbid condition. Specifically, the high dose formulation is for adults who've tolerated the 2.4 mg dose for at least 4 weeks and for whom additional weight reduction is clinically indicated.
Efficacy
Approval was based on results from two randomized, double-blind, parallel group phase 3b studies which included adults with a body mass index of at least 30 kg/m2, with or without diabetes (STEP UP T2D and STEP UP, respectively). In both studies, participants were randomized to receive a once-weekly subcutaneous injection of semaglutide 7.2 mg, semaglutide 2.4 mg, or placebo, alongside lifestyle intervention. The studies included a dose escalation period of 20 weeks, followed by maintenance dosing until 72 weeks. Co-primary endpoints were relative percent change in body weight from baseline to week 72 and proportion of participants who achieved body weight reduction of at least 5% from baseline to week 72, for semaglutide 7.2 mg vs. placebo.
Results from the treatment-regimen estimand (treatment effect regardless of treatment adherence) showed semaglutide 7.2 mg led to greater reductions in body weight compared with placebo (STEP UP: 18.8% vs. 3.9%; STEP UP T2D: 13.2% vs. 3.8%). Additionally, a greater proportion of patients in the semaglutide 7.2-mg group reported a weight loss of at least 5% vs. those in the placebo group (STEP UP: 88.7% vs. 38.3%; STEP UP T2D: 83.7% vs. 34%).
Safety
Most common adverse reactions (≥2% and greater than placebo) were nausea, vomiting, dysesthesia, constipation, abdominal pain, fatigue, headache, dizziness, hair loss, and flatulence. Of note, dysesthesia, and related events of altered skin sensations including paresthesia, hyperesthesia, burning sensation, allodynia, skin burning sensation, pain of skin, and sensitive skin, were reported more frequently in the semaglutide 7.2 mg arm (22%) compared with the semaglutide 2.4 mg and placebo arms (6% and 0%, respectively). FDA is currently conducting further investigations regarding this drug reaction.
Sources:
(2026, March 19). Novo Nordisk A/S: Wegovy HD (semaglutide 7.2 mg) approved in the US, providing 20.7% mean weight loss. [Press release]. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html
(2026, March 19). FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide. [News release]. https://www.fda.gov/news-events/press-announcements/fda-approves-fourth-product-under-national-priority-voucher-program-higher-dose-semaglutide
Wegovy (semaglutide). [Package insert]. Novo Nordisk Inc. https://www.novo-pi.com/wegovy.pdf Revised March 2026.
