A 6-month randomized, double-blind, placebo-controlled trial of weekly exenatide in adolescents with obesity.

Abstract

BACKGROUND:

Pharmacological treatment options for adolescents with obesity are very limited. Glucagon-like-peptide-1 (GLP-1) receptor agonist could be a treatment option for adolescent obesity.

OBJECTIVE:

To investigate the effect of exenatide extended release on body mass index (BMI)-SDS as primary outcome, and glucose metabolism, cardiometabolic risk factors, liver steatosis, and other BMI metrics as secondary outcomes, and its safety and tolerability in adolescents with obesity.

METHODS:

Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m2 according to WHO were included. Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly. Oral glucose tolerance tests (OGTT) were conducted at the beginning and end of the intervention.

RESULTS:

Exenatide reduced (P < .05) BMI-SDS (-0.09; -0.18, 0.00), % BMI 95th percentile (-2.9%; -5.4, -0.3), weight (-3 kg; -5.8, -0.1), waist circumference (-3.2 cm; -5.8, -0.7), subcutaneous adipose tissue (-552 cm3 ; -989, -114), 2-hour-glucose during OGTT (-15.3 mg/dL; -27.5, -3.1), total cholesterol (11.6 mg/dL; -21.7, -1.5), and BMI (-0.83 kg/m2 ; -1.68, 0.01) without significant change in liver fat content (-1.36; -3.12, 0.4; P = .06) in comparison to placebo. Safety and tolerability profiles were comparable to placebo with the exception of mild adverse events being more frequent in exenatide-treated patients.

CONCLUSIONS:

Treatment of adolescents with severe obesity with extended-release exenatide is generally well tolerated and leads to a modest reduction in BMI metrics and improvement in glucose tolerance and cholesterol. The study indicates that the treatment provides additional beneficial effects beyond BMI reduction for the patient group.

• Authors: D Weghuber, A Forslund, H Ahlström, A Alderborn, K Bergström, S Brunner, J Cadamuro, I Ciba, M Dahlbom, V Heu, J Hofmann, H Kristinsson, J Kullberg, A Ladinger, F B Lagler, M Lidström, H Manell, M Meirik, K Mörwald, K Roomp, R Schneider, H Vilén, K Widhalm, F Zsoldos, P Bergsten
• Journal: Pediatric obesity (Pediatr Obes) Vol. 15 Issue 7 Pg. e12624 (07 2020) ISSN: 2047-6310 [Electronic] England
• PMID: 32062862 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2020 The Authors. Pediatric Obesity published by John Wiley & Sons Ltd on behalf of World Obesity Federation.

Chemical References

• Anti-Obesity Agents
• Exenatide

Topics

• Adolescent
• Anti-Obesity Agents (therapeutic use)
• Body Mass Index
• Child
• Double-Blind Method
• Exenatide (therapeutic use)
• Female
• Glucose Tolerance Test
• Humans
• Male
• Pediatric Obesity (drug therapy, metabolism)