Workflow
Next generation obesity drugs
icon
Search documents
Veru Enrolls First Patient in Phase 2b PLATEAU Clinical Trial of Enobosarm and Semaglutide Combination for High Quality Weight Loss
Globenewswire· 2026-03-09 12:30
Core Viewpoint - Veru Inc. has initiated the Phase 2b PLATEAU clinical trial for enobosarm, aimed at enhancing weight loss quality and quantity in older patients with obesity when combined with semaglutide [1][2] Group 1: Clinical Trial Details - The Phase 2b PLATEAU trial is a double-blind, placebo-controlled study involving approximately 200 older patients (age ≥ 65 years) with obesity (BMI ≥ 35) starting semaglutide treatment [3] - The primary efficacy endpoint is the percent change from baseline in total body weight at 68 weeks, with an interim analysis at 34 weeks to assess changes in lean body mass and fat mass [3][6] - Key secondary endpoints include total fat mass, total lean mass, physical function, bone mineral density, and patient-reported outcomes [3] Group 2: Drug Development Strategy - Enobosarm is an oral selective androgen receptor modulator (SARM) being developed to work in conjunction with GLP-1 receptor agonists like semaglutide to maximize fat loss while preserving lean mass and physical function [2][4] - The combination therapy aims to address the weight loss plateau experienced by many patients on current therapies, particularly those with clinical obesity [2][4] - The Phase 2b PLATEAU study builds on previous positive results from the Phase 2 QUALITY clinical study, which demonstrated the efficacy of enobosarm in combination with semaglutide [4][8] Group 3: Expected Outcomes and Timeline - An interim analysis for the PLATEAU trial is expected in the first quarter of 2027, with final topline clinical data anticipated in the fourth quarter of 2027 [1][6] - The trial aims to provide critical clinical information that will inform the design of future Phase 3 studies for combination therapies [2][3]