ODP350 Safety and Efficacy of Tesomet over 48 Weeks of Treatment: Results From a 24-Week Phase 2, Randomized, Double-Blind Study With 24 Week Open-Label Extension in Adults With Hypothalamic Obesity

ABSTRACT: Abstract

Objective

To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.

Research Design and Methods

Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period. On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet. The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition. Trial NCT03845075.

Results

The most common adverse events following the 24-wee

SUBMITTER:  

PROVIDER: S-EPMC9625380 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature