Semaglutide Treatment Effect in People With Obesity - STEP TEENS

Dec 20, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, FACC, MBA
Trial Sponsor:
Novo Nordisk
Date Published:
12/15/2022
Date Updated:
12/20/2022
Original Posted Date:
12/21/2022
References

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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