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.


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)


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.


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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