Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss
brief summary
The primary objective of this study is to assess the effect of enobosarm on total body weight
detailed description
This study is a multicenter, randomized, double-blind, and placebo-controlled study. Subjects will be randomized into two treatment arms (subcutaneous injectable semaglutide plus oral enobosarm 3mg dose group or subcutaneous injectable semaglutide plus placebo group) in a 1:1 fashion. All patients randomized into this study will initiate semaglutide subcutaneous injection therapy for weight reduction on Day 1 of this study.
The primary efficacy endpoint of the study will be the percent change from baseline in total body weight at 68 weeks (476 days). A safety follow up visit will occur approximately 30 days after last dose of study drug.
official title
PLATEAU: Phase 2b Proof-of-Concept Study to Evaluate the Effect on Total Body Weight, Physical Function and Safety of Enobosarm in Patients Treated With Semaglutide, a Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist, for Weight Reduction