Drugs

Study on Enhancing Weight-Loss Drugs

FDA has approved a Veru IND to begin a Phase 2b clinical study to evaluate enobosarm, an oral novel selective androgen receptor modulator (SARM) and its use in preserving muscle mass and physical function and increasing fat loss in patients receiving a Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drug. While GLP-1 RA drugs are very effective in promoting significant weight loss, “studies have shown that up to 50% of the total weight loss comes from muscle which is problematic as muscle is essential for metabolism, strength, and physical function,” the company says.

The Phase 2b dose-finding clinical trial is designed to evaluate 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,” according to Veru. The study is expected to begin in April, and the primary endpoint is lean body mass (muscle), and the key secondary endpoint is total body fat mass at 16 weeks.

“After completing the efficacy dose-finding portion of the Phase 2b clinical trial, participants will then continue into an open label extension trial where all patients will receive 6 mg of enobosarm monotherapy for 12 weeks to determine the ability of enobosarm to rescue, or reverse muscle loss and prevent fat and weight rebound after stopping a GLP-1 RA,” the company says.

Enobosarm has been previously studied in five clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. “Advanced cancer simulates a ‘starvation state’ where there is significant unintentional loss or wasting of both muscle and fat mass similar to what is observed with GLP-1 RA treatment,” Veru says. “The totality of the clinical data from these five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome