Veru announces FDA clearance of IND application for Phase 2b with enobosarm

Veru announced that the U.S. Food and Drug Administration, FDA, has cleared the company’s Investigational New Drug, IND, application for its Phase 2b clinical study to evaluate enobosarm, an oral novel selective androgen receptor modulator, SARM, to preserve muscle mass and physical function and further increase fat loss in patients receiving a Glucagon-like peptide-1 receptor agonist drug for potentially higher quality weight loss. The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 90 sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness. The primary endpoint is lean body mass, and the key secondary endpoint is total body fat mass at 16 weeks. The clinical study is expected to begin by April 2024 with the topline clinical results from the trial expected in the end of the fourth calendar quarter of 2024.