Semaglutide Treatment Effect in People With Obesity - STEP TEENS
Contribution To Literature:
The STEP TEENS trial showed that among obese adolescents, semaglutide was associated with greater weight loss compared with placebo.
Description:
The goal of the trial was to evaluate semaglutide compared with placebo among adolescents with obesity. Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue approved for treatment of diabetes and to reduce the risk of cardiovascular events among individuals with diabetes and cardiovascular disease.
Study Design
- Randomized
- Parallel
- Placebo
Obese adolescents were randomized to semaglutide (n = 134) vs. lifestyle intervention (n = 67). Semaglutide was given at a dose of 2.4 mg subcutaneous, once weekly.
- Total number of enrollees: 201
- Duration of follow-up: 68 weeks
- Mean patient age: 16 years
- Percentage female: 63%
Inclusion criteria:
- Age 12 to <18 years of age
- Body mass index (BMI) ≥95th percentile
Exclusion criteria:
- Weight change >5 kg or use of weight loss medication within last 90 days
- Prior bariatric surgery
- Uncontrolled thyroid disease
- Secondary cause of obesity
- Major depressive disorder, severe psychiatric disorder, or bulimia nervosa
- History of suicide attempt
Principal Findings:
The primary outcome, change in BMI, was -16.1% in the semaglutide group vs. 0.6% in the placebo group (p < 0.001).
Secondary outcomes:
- Weight loss ≥5%: 73% in the semaglutide group vs. 18% in the placebo group (p < 0.001)
- Any adverse event: 79% in the semaglutide group vs. 82% in the placebo group (p < 0.001)
Interpretation:
Among adolescents with obesity, semaglutide was associated with greater weight loss compared with placebo. Semaglutide was associated with a higher frequency of adverse events compared with placebo. Obesity is a major public health problem and semaglutide may represent an option for treatment when lifestyle modifications are not successful.
References:
Weghuber D, Barrett T, Barrientos-Pérez M, et al. Once-weekly semaglutide in adolescents with obesity. N Engl J Med 2022;387:2245-57.
Clinical Topics: Cardiovascular Care Team, Congenital Heart Disease and Pediatric Cardiology, Diabetes and Cardiometabolic Disease, Prevention, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Prevention
Keywords: Adolescent, Anti-Obesity Agents, Body Mass Index, Diabetes Mellitus, Glucagon-Like Peptide 1, Hypoglycemic Agents, Life Style, Metabolic Syndrome, Obesity, Pediatric Obesity, Primary Prevention, Weight Loss
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