Semaglutide 2.4 mg cut BMI 16.1% in adolescents in STEP TEENS trial
The randomized trial found weekly semaglutide 2.4 mg lowered BMI in teenagers with obesity, with gastrointestinal side effects and gallstones more common than on placebo.
Once-weekly semaglutide 2.4 mg lowered body-mass index by 16.1% in adolescents with obesity over 68 weeks, while BMI rose slightly in those taking placebo, according to results from the STEP TEENS trial published on November 2, 2022 [1].
The trial enrolled 201 adolescents between 12 and under 18 years old. Participants had obesity, defined as a BMI at or above the 95th percentile, or overweight, defined as a BMI at or above the 85th percentile, plus at least one weight-related coexisting condition. All but one of the participants had obesity [1].
Participants were randomly assigned in a 2:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks. Everyone in both groups also received a lifestyle intervention. Of the 201 adolescents who underwent randomization, 180 (90%) completed treatment [1].
BMI fell by a mean of 16.1% from baseline to week 68 in the semaglutide group and rose by 0.6% in the placebo group, an estimated difference of 16.7 percentage points (95% confidence interval, -20.3 to -13.2; P<0.001) [1].
At week 68, 95 of 131 participants (73%) taking semaglutide had lost at least 5% of their body weight, compared with 11 of 62 participants (18%) taking placebo (estimated odds ratio, 14.0; 95% CI, 6.3 to 31.0; P<0.001) [1].
Reductions in body weight and improvements in cardiometabolic risk factors were greater with semaglutide than with placebo. Those measures included waist circumference, glycated hemoglobin, lipids (except HDL cholesterol) and alanine aminotransferase [1].
Gastrointestinal adverse events were more common with semaglutide than with placebo, reported in 62% of participants taking the drug versus 42% taking placebo. Five participants (4%) in the semaglutide group had cholelithiasis, or gallstones, and none in the placebo group did. Serious adverse events were reported in 15 of 133 participants (11%) taking semaglutide and 6 of 67 participants (9%) taking placebo [1]. The study was funded by Novo Nordisk and registered as NCT04102189 [1].
Why it matters for patients
Before this trial, the 2.4-mg subcutaneous dose of semaglutide was used to treat obesity in adults, but assessment of the drug in adolescents had been lacking [1]. The results give families and clinicians randomized data on how the drug performed in teenagers over 68 weeks, rather than evidence carried over from adult studies.
The trial tested semaglutide together with a lifestyle intervention, and that combination is what was compared with a lifestyle intervention plus placebo, so the results reflect the two together rather than the drug alone [1].
The teenagers in the trial were 12 or older. How the drug behaves in children younger than 12 has not been reported [1]. The trial included a follow-up period after participants stopped taking semaglutide or placebo, but the published results do not report what happened to BMI or weight during that period, so whether weight was regained after treatment ended is not yet known [1].
Side effects matter for this age group: gastrointestinal symptoms affected a majority of those taking semaglutide, and gallstones occurred in five of them and none of the participants on placebo [1].
What happens next
The New England Journal of Medicine published three letters about the trial on March 23, 2023, along with a reply from the trial authors [1]. Longer-term results from STEP TEENS, including what happened to participants after treatment stopped, have not been reported in the published record [1].
Sources
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