Veru Names Steven B. Heymsfield M.D. Lead Investigator for Enobosarm Phase 2b High Quality Weight Loss Trial

Veru Inc., a biopharmaceutical company based in Miami, Florida, has named Dr. Steven B. Heymsfield as the Principal Investigator for its Phase 2b clinical trial of enobosarm. This trial aims to evaluate enobosarm's ability to preserve muscle mass while promoting fat loss in patients using GLP-1 receptor agonists (GLP-1 RA) for weight loss. Dr. Heymsfield, a Professor and Director of the Body Composition-Metabolism Laboratory at Pennington Biomedical Research Center, is a prominent expert in body composition and obesity.

Dr. Heymsfield's extensive background includes a degree in medicine from Mount Sinai School of Medicine and advanced training in pharmacology at Emory University. His professional journey spans multiple prestigious institutions, including Columbia University, where he served as Professor of Medicine and Deputy Director of the New York Obesity Research Center. He also held senior positions at Merck & Co., contributing significantly to obesity research and scientific affairs. With over 600 peer-reviewed publications, Dr. Heymsfield is recognized for his contributions to obesity, malnutrition, cachexia, and body composition studies.

In his new role, Dr. Heymsfield will oversee the clinical trial sites, participate in the study analysis, and report results to the FDA and scientific communities. He expressed enthusiasm about leading this critical trial, highlighting enobosarm's potential to enhance the quality of weight loss by preserving muscle mass in patients undergoing GLP-1 RA therapy.

Mitchell Steiner, M.D., the CEO of Veru Inc., emphasized Dr. Heymsfield's expertise and the significant unmet medical need addressed by this trial. Steiner noted that muscle loss is a critical issue for patients using GLP-1 RAs for weight loss, and enobosarm could potentially improve their weight loss journey by preserving muscle mass.

The Phase 2b clinical trial is a multicenter, double-blind, placebo-controlled, randomized study designed to assess the safety and efficacy of enobosarm at two dosage levels (3mg and 6mg) compared to a placebo. It will involve approximately 90 patients with sarcopenic obesity or elderly individuals over 60 years old who are taking semaglutide (Wegovy®). The primary endpoint is the difference in total lean body mass, with secondary endpoints including differences in total body fat mass and physical function, measured by a stair climb test at 16 weeks. The trial is currently enrolling patients across up to 15 sites in the United States, with initial results expected by the end of 2024.

Upon completing the initial phase, participants will enter a blinded extension trial, continuing their assigned treatment without GLP-1 RA for an additional 12 weeks. This extension aims to determine whether enobosarm can maintain muscle mass and prevent fat regain after discontinuing GLP-1 RA therapy. Topline results from this extension trial are anticipated in the second quarter of 2025.

Sarcopenic obesity, characterized by low muscle mass in obese individuals, poses significant health risks, especially for older adults. The CDC indicates that 41.5% of older adults in the U.S. are obese, with up to 34.4% of those over 60 suffering from sarcopenic obesity. This condition exacerbates the negative effects of GLP-1 RA-induced muscle loss, leading to increased frailty, mobility issues, and higher mortality rates.

Enobosarm, also known by various names including ostarine and MK-2866, is a selective androgen receptor modulator (SARM) previously studied in multiple clinical trials. These studies have shown enobosarm's potential to increase muscle mass and physical function while reducing fat mass, providing a strong rationale for its use alongside GLP-1 RA therapy.

Veru Inc. is dedicated to advancing enobosarm and other novel treatments for metabolic diseases, oncology, and acute respiratory distress syndrome (ARDS). The company is also developing sabizabulin, a microtubule disruptor, for treating viral-induced ARDS, pending additional funding. Veru's commercial portfolio includes the FDA-approved FC2 Female Condom® for dual protection against unplanned pregnancy and sexually transmitted infections.