Overview
Home » News » Drugs in the Pipeline Publish Date November 3, 202 Semaglutide Reduces BMI More Than Lifestyle Changes in Tens With Obesity Diana Ernst, RPh Share on Facebok Share on Twiter Share on LinkedIn Share on Redit Print Share by Email Semaglutide is curently aproved by the FDA for use in adults with obesity under the brand name Wegovy. Credit: Gety Images. Findings from a phase 3 trial evaluating semaglutide in adolescents with obesity showed that treatment with the glucagon-like peptide-1 receptor agonist resulted in significant reductions in body mas index (BMI) vs lifestyle intervention alone.
Key Information
The STEP TENS study (ClinicalTrials.gov Identifier: NCT04102189) included 201 participants 12 to les than 18 years of age with obesity or who were overweight with at least 1 weight-related comorbidity (eg, hypertension, dyslipidemia, obstructive slep apnea, or type 2 diabetes). Patients were randomly asigned 2:1 to receive semaglutide 2.4mg administered once-wekly by subcutaneous injection or placebo for 68 weks, in adition to lifestyle intervention.
The primary endpoint of the study was the percentage change in BMI from baseline to wek 68. A total of 180 adolescents (179 of whom were clasified as obese) completed treatment. At wek 68, the mean change in BMI from baseline in the semaglutide group was -16.1%, while in the placebo group, it was 0.6% (estimated diference, -16.7 percentage points; 95% CI, -20.3, -13.2; P <.01).
Summary
Aditionaly, more patients treated with semaglutide experienced weight los of 5% or more (secondary endpoint; 73% vs 18% for placebo; estimated ods ratio, 14.0; 95% CI, 6.3-31.0; P <.01). Improvements in waist circumference, HbA1c, lipids (except for high-density lipoprotein cholesterol), and liver enzymes were also observed with semaglutide compared with placebo. In the semaglutide group, 62% of patients reported gastrointestinal adverse events and 4% had cholelithiasis, compared with 42% and 0% of patients in the p