First Participants Enrolled in Veru's Phase 2b Trial of Enobosarm-Semaglutide for Optimal Weight Loss

Veru Inc., a biopharmaceutical firm specializing in innovative treatments for muscle preservation, oncology, and respiratory distress syndrome, has recently initiated its Phase 2b clinical trial for enobosarm. This oral medication, a selective androgen receptor modulator, is being tested for its potential to prevent muscle loss and enhance fat reduction when combined with semaglutide, a GLP-1 RA drug. The trial, anticipated to produce results by the end of 2024, has enrolled its first participants.

The company's CEO, Mitchell Steiner, highlighted the significance of this trial in addressing the need for a therapy that can maintain muscle mass during weight loss treatments with GLP-1 drugs. He noted that older patients, particularly those with obesity and low muscle reserves, are prone to muscle weakness and increased risk of injuries such as falls and fractures, which can be exacerbated by weight loss therapies.

Louis Aronne, an obesity medicine specialist and Veru's Chief Medical Advisor, emphasized the importance of improving the quality of weight loss by minimizing the loss of lean mass to better manage obesity-related metabolic issues. The Phase 2b trial is a multicenter, double-blind, placebo-controlled study that will assess the safety and efficacy of enobosarm in approximately 90 patients with sarcopenic obesity or who are elderly and overweight, receiving semaglutide. The primary goal is to measure the difference in total lean body mass, with secondary endpoints focusing on body fat mass and physical function.

Following the initial phase, participants will enter an extension trial where they will discontinue GLP-1 RA treatment but continue with enobosarm or placebo for an additional 12 weeks. This will evaluate enobosarm's ability to sustain muscle mass and prevent weight gain post-discontinuation of GLP-1 RA treatment, with results expected in the second quarter of 2025.

Sarcopenic obesity is a prevalent condition, affecting a significant portion of older adults in the U.S., who are at an increased risk when taking GLP-1 RA drugs due to their already low muscle mass. This can lead to frailty, poor balance, decreased mobility, and higher mortality rates.

Enobosarm has been studied in previous clinical trials involving nearly a thousand participants, demonstrating its ability to increase muscle mass and reduce fat mass while improving physical function. With a robust safety profile and well-tolerated nature, enobosarm shows promise when combined with GLP-1 RA drugs for enhanced weight loss and muscle preservation.

Veru Inc. is also developing sabizabulin for the treatment of viral-induced ARDS and has an FDA-approved product, the FC2 Female Condom®, for protection against unplanned pregnancies and sexually transmitted infections. The company is committed to advancing its drug development program with a focus on metabolic diseases and oncology.