STEP UP: High-dose semaglutide led to 21% weight loss for adults with obesity
Key takeaways:
- Treatment with once-weekly semaglutide 7.2 mg conferred a 20.7% weight reduction vs. a 17.5% weight loss with semaglutide 2.4 mg.
- The safety profile of semaglutide 7.2 mg is similar to other GLP-1s.
Adults with obesity receiving once-weekly semaglutide 7.2 mg lost a higher proportion of their body weight at 72 weeks than adults receiving semaglutide 2.4 mg, according to top-line results from the STEP UP phase 3b trial.
The trial enrolled 1,407 adults with a BMI of 30 kg/m2 or higher and without diabetes. Participants were randomly assigned to once-weekly semaglutide 7.2 mg, once-weekly semaglutide 2.4 mg (Wegovy, Novo Nordisk) or placebo along with lifestyle intervention for 72 weeks. The trial’s primary outcome was superiority in weight loss with semaglutide 7.2 mg vs. placebo.
In the trial product estimand, adults receiving semaglutide 7.2 mg had a 20.7% weight loss at 72 weeks compared with a 17.5% weight reduction with semaglutide 2.4 mg and a 2.4% weight loss with placebo. A weight loss of 25% or more was achieved by 33.2% of the semaglutide 7.2 mg group compared with 16.7% of those receiving semaglutide 2.4 mg.
Semaglutide 7.2 mg had a safety profile consistent with other GLP-1 receptor agonists, according to the press release. The most common adverse events were gastrointestinal and were mild or moderate in nature.
More detailed results from the STEP UP trial are expected to be presented at a scientific conference in 2025.
“Results from STEP UP further strengthen the clinical profile of semaglutide for the treatment of obesity, in addition to the health benefits already established with Wegovy, including cardiovascular risk reduction as seen in SELECT,” Martin Holst Lange, MD, PhD, executive vice president for development at Novo Nordisk, said in a press release.
Steven B. Heymsfield, MD, FTOS, professor in the department of metabolism and body composition at Pennington Biomedical Research Center at Louisiana State University, said the top-line results released by Novo Nordisk indicate modestly greater weight loss with semaglutide 7.2 mg compared with semaglutide 2.4 mg, but the weight reduction with semaglutide 7.2 mg appears to be less than what was observed with tirzepatide 15 mg (Mounjaro, Eli Lilly) in the SURMOUNT-1 trial. Additionally, Heymsfield said more data are needed on whether the safety profile of semaglutide 7.2 mg differs from the 2.4 mg dose.
“The question is if that extra weight loss is worth the added side effects,” Heymsfield told Healio. “It is always a concern when [increasing] drug doses that you enter territory with risks that are unmasked and that were not seen at lower doses.”
Semaglutide 7.2 mg is also being assessed in adults with obesity and type 2 diabetes in the STEP UP T2D trial. Top-line results from STEP UP T2D are expected in the next few months, according to Novo Nordisk.
For more information:
Steven B. Heymsfield, MD, FTOS, can be reached at steven.heymsfield@pbrc.edu.
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