In the STEP UP phase 3 trial, adults with obesity taking semaglutide 7.2 mg as directed lost an average of 20.7% body weight
Novo Nordisk has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for a higher 7.2 mg dose of semaglutide injection. This medication is intended to support chronic weight management in adults living with obesity when combined with a reduced-calorie diet and increased physical activity. The submission is part of the FDA’s CNPV expedited review program, which is expected to provide a response within one to two months following acceptance.
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Anna Windle, PhD, senior vice president of Clinical Development, Medical and Regulatory Affairs at Novo Nordisk, stated that the company’s expanding pipeline reflects a commitment to addressing the needs of individuals living with obesity. She added that the expedited review submission represents a meaningful step forward and that if approved, semaglutide 7.2 mg could offer patients and healthcare providers a new option with greater potential for weight loss, further demonstrating the effectiveness of the semaglutide molecule. Novo Nordisk looks forward to working closely with the FDA to make this option available to the obesity community as quickly as possible.
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The sNDA submission is supported by data from the STEP UP trial, a 72-week phase 3, randomized, double-blind, placebo-controlled and active-controlled study that examined the efficacy and safety of once-weekly semaglutide 7.2 mg in 1,407 adults with obesity. Participants with diabetes were excluded. The trial compared semaglutide 7.2 mg to placebo and the currently approved 2.4 mg dose, with all participants following lifestyle interventions alongside treatment.
Results from the STEP UP trial showed that from a mean baseline body weight of 249 pounds, participants taking semaglutide 7.2 mg experienced an average weight loss of 20.7 percent after 72 weeks compared with 17.5 percent for the 2.4 mg dose and 2.4 percent for placebo among those who adhered to treatment. Among those receiving semaglutide 7.2 mg, 33.2 percent achieved weight loss of 25 percent or more, while only 16.7 percent on 2.4 mg and none on placebo reached this milestone. When analyzed including participants who discontinued treatment, weight reduction was 18.7 percent for semaglutide 7.2 mg, 15.6 percent for 2.4 mg, and 3.9 percent for placebo. Ninety point seven percent of participants on 7.2 mg achieved at least a five percent reduction in body weight compared with 89.9 percent on 2.4 mg and 36.8 percent on placebo.
The safety profile indicated that gastrointestinal events were more frequent with semaglutide 7.2 mg compared with the 2.4 mg dose or placebo. Dysaesthesia was also reported more often. Serious adverse events occurred in 6.8 percent of participants on semaglutide 7.2 mg, 10.9 percent on 2.4 mg, and 5.5 percent on placebo. The higher 7.2 mg dose of Wegovy is also under review by the European Medicines Agency, the United Kingdom, and several other countries, with Novo Nordisk anticipating a regulatory decision in the European Union in the first quarter of 2026.
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