Written By: Pharmacally Medical News Desk
Novo Nordisk has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a higher 7.2 mg dose of Wegovy® (Semaglutide injection), aimed at chronic weight management in adults with obesity alongside diet and exercise. This filing leverages the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program, accelerating review to 1-2 months post-acceptance due to obesity’s status as a national health priority. The application builds on prior user interest in semaglutide’s effects beyond weight loss, such as benefits in Cardiovascular Health and MASH.
STEP UP Phase 3 Trial Design
The sNDA incorporates data from the STEP UP trial (NCT05646706), a 72-week, randomized, double-blind, placebo- and active-controlled superiority study involving 1,407 adults with obesity (BMI ≥30 kg/m²). Participants received once-weekly Semaglutide 7.2 mg, 2.4 mg (current max dose), or placebo as an adjunct to lifestyle intervention. The trial assessed weight loss efficacy and safety, with primary endpoints focused on percentage body weight reduction.
Key Efficacy Results
Adults who adhered to the treatment regimen and received Semaglutide 7.2 mg experienced an average body weight reduction of 20.7% over 72 weeks, which was higher than the 17.5% weight loss seen with the 2.4 mg dose and the 2.4% loss observed with placebo.
When considering all participants regardless of treatment adherence (treatment-policy estimand), those on Semaglutide 7.2 mg showed an average weight reduction of 18.7%, compared to 15.6% for the 2.4 mg dose and 3.9% for placebo.
About 90.7% of patients treated with Semaglutide 7.2 mg achieved at least 5% weight loss, closely comparable to 89.9% in the 2.4 mg group but substantially higher than the 36.8% in the placebo group.
A significant 33.2% of adults on the 7.2 mg dose achieved a weight loss of 25% or more, nearly double the 16.7% rate seen with 2.4 mg and none in the placebo group.
These results demonstrate that Semaglutide 7.2 mg provides a superior level of weight loss compared to the currently approved 2.4 mg dose and placebo, offering a more effective option for patients needing greater weight reduction.
Gastrointestinal adverse events were more common with 7.2 mg than lower doses or placebo, alongside higher dysesthesia rates; serious adverse events occurred in 6.8% of 7.2 mg participants vs. 10.9% (2.4 mg) and 5.5% (placebo). The overall safety profile aligns with known Semaglutide effects at lower doses. No new safety signals emerged that would halt pursuit of approval.
Novo Nordisk’s senior VP, Anna Windle, highlighted that their expanding pipeline addresses obesity needs, and the expedited FDA submission for Semaglutide 7.2 mg represents a major advancement. If approved, this higher dose will offer patients and healthcare professionals a new option for greater weight loss potential, reinforcing the proven efficacy of Semaglutide.
The 7.2 mg dose is already under EMA review, with an EU decision expected in Q1 2026, alongside filings in the UK and other regions. FDA acceptance could yield a decision by early 2026, potentially expanding Wegovy’s labeling amid rising obesity treatment demand. This aligns with Novo Nordisk’s pipeline focus on obesity innovations.
Reference
Novo Nordisk files for FDA approval of a higher dose of Wegovy® injection 7.2 mg, Novo Nordisk, 26 November 2025, https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916464
Higher-Dose Semaglutide Achieves Historic 21% Weight Loss in Landmark STEPUP Trial, Pharmacally, 16 October 2025, https://pharmacally.com/higher-dose-semaglutide-achieves-historic-21-weight-loss-in-landmark-step-up-trial/