Kyle LaHucik May
Associate Editor

A few months after the FDA approved the weight loss drug Wegovy for adolescents, researchers are out with a post-hoc look at the late-stage data, this time finding that 45% of the teens taking Novo Nordisk’s drug dipped below the clinical cutoff for obesity.
The analysis, presented by University of Minnesota pediatrics professor Aaron Kelly at this week’s European Congress on Obesity in Dublin, gives new insight into the popular drug, which is part of the ballooning obesity R&D field that has Novo and Eli Lilly in the lead and biopharmas like Amgen and Boehringer Ingelheim racing to catch up.
The results from the same study, the STEP TEENS trial, were published in the New England Journal of Medicine last December, shortly before the FDA expanded the original 2021 label for adults to include teens 12 years old and older.
Almost three-quarters (74%) of teens taking the drug moved into a different body mass index category, Kelly reported. In the placebo group, 19% of participants experienced that BMI change. The clinical trial included 134 people on once-weekly Wegovy (2.4 mg of the injection) and 67 on placebo for 68 weeks. Participants were also provided “lifestyle counseling.”
Aaron Kelly
At the time of randomization, all but one participant was considered to have obesity, defined as having BMI in the highest 5% of their age and sex. The researchers looked at three levels of obesity, with the first class being above the 95th percentile cutoff, the second class having BMI 20% higher than that cutoff, and the third class having 40% more than the threshold, based on the Centers for Disease Control and Prevention’s BMI ranges.
Overall, 45% of those on Wegovy had enough of a reduction in BMI to enter “overweight” or “normal weight” groups, as compared to 12% of people in the placebo portion.
The secondary analysis was led by Kelly, co-director of the University of Minnesota’s Center for Pediatric Obesity Medicine. Kelly has done unpaid consulting and educational activities for Novo, Boehringer, Lilly and Vivus.
In the recorded press conference, Kelly said he often gets asked, “Is this going to solve the obesity problem, and should we give it to everybody?”
“No, and no,” he said. Anti-obesity medications, he said, are part of a broader, comprehensive approach that includes lifestyle therapy, sometimes bariatric surgery and other measures.
The new look at the Phase IIIa data comes as Novo said it would restrict starter doses earlier this month because of the “all-time high levels” of demand as people rush to get the GLP-1 drug.