Dataset Information

A phase 3 randomized clinical trial using a once-weekly glucagon-like peptide-1 receptor agonist in adolescents and young adults with hypothalamic obesity.

ABSTRACT:

Aim

To evaluate the efficacy, safety and tolerability of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in patients with hypothalamic obesity (HO).

Materials and methods

A two-arm, randomized, multicentre, double-blind, placebo-controlled trial was conducted in 10- to 25-year-olds with hypothalamic injury following intracranial tumour and HO. Participants were randomized to once-weekly subcutaneous injections of a GLP-1 RA exenatide 2 mg (ExQW) or placebo for 36?weeks. The primary efficacy endpoint was 36-week % change in body mass index (BMI). Secondary outcomes included change in body composition (by dual energy x-ray absorptiometry).

Results

Forty-two participants were randomized to ExQW (n = 23) or placebo (n = 19). Participants were 5 ±?2?years (mean?±?SD) postdiagnosis and development of HO (BMI 37.3 ±?7.1 kg/m² ). In intention-to-treat analysis, the effect of 36-week ExQW vs. placebo on % ? BMI was not significant (estimated treatment difference -1.7 ± 1.8%, 95% CI -4.1 to 0.6%, P = .40); however, total body fat mass was reduced (estimated treatment difference?-3.1 ±?1.4 kg, 95% CI -5.7 to -0.4 kg, P =?.02). There was a significant reduction in waist circumference (estimated effect of treatment -3.5 [95% CI -5.5 to -1.6] cm, P =?.004). All patients treated with placebo increased % of adipose tissue, while 50% treated with ExQW had reductions (P ConclusionsGLP-1 RAs are a promising and safe treatment to improve or stabilize HO in children and young adults.

SUBMITTER: Roth CL

PROVIDER: S-EPMC7821019 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

A phase 3 randomized clinical trial using a once-weekly glucagon-like peptide-1 receptor agonist in adolescents and young adults with hypothalamic obesity.

Roth Christian L CL Perez Francisco A FA Whitlock Kathryn B KB Elfers Clinton C Yanovski Jack A JA Shoemaker Ashley H AH Abuzzahab M Jennifer MJ

Diabetes, obesity & metabolism 20201025 2

<h4>Aim</h4>To evaluate the efficacy, safety and tolerability of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in patients with hypothalamic obesity (HO).<h4>Materials and methods</h4>A two-arm, randomized, multicentre, double-blind, placebo-controlled trial was conducted in 10- to 25-year-olds with hypothalamic injury following intracranial tumour and HO. Participants were randomized to once-weekly subcutaneous injections of a GLP-1 RA exenatide 2 mg (ExQW) or placebo for 36 weeks. The ...[more]

PMID: 33026160

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Dataset Information

A phase 3 randomized clinical trial using a once-weekly glucagon-like peptide-1 receptor agonist in adolescents and young adults with hypothalamic obesity.

Aim

Materials and methods

Results

Publications

A phase 3 randomized clinical trial using a once-weekly glucagon-like peptide-1 receptor agonist in adolescents and young adults with hypothalamic obesity.

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