Recently, Veru, a company focused on biopharmaceutical research and development, announced the latest research results of its SARM (Selective Androgen Receptor Modulator) product series. Enobosarm, an investigational drug, has achieved positive topline results in the Phase 2b QUALITY clinical study, which is expected to bring new solutions to problems related to obesity and muscle decline.
QUALITY is a multicenter, double – blind, placebo – controlled, randomized dose – finding Phase 2b study. It aims to evaluate the safety and efficacy of enobosarm (3mg and 6mg) and placebo in 168 elderly patients aged 60 and above who are overweight or obese and are receiving treatment with the GLP – 1 receptor agonist Wegovy (semaglutide). The primary endpoint of the study is the change in total lean body mass from baseline to 16 weeks, and the key secondary endpoints include changes in total fat mass, body weight from baseline to 16 weeks, and physical function assessed by the stair – climbing test.
The results show that the trial successfully reached the primary endpoint. All patients receiving enobosarm in combination with GLP – 1 drugs showed a significant protective effect on total lean body mass at 16 weeks, with a statistically significant advantage compared to the placebo group. In terms of secondary endpoints, the enobosarm plus GLP – 1 drug treatment was also superior to the placebo group in reducing total fat mass at 16 weeks. At the same time, compared with the placebo group, the proportion of subjects in the enobosarm group who lost ≥ 10% of their stair – climbing ability was significantly reduced, and the results are clinically significant.
Enobosarm (also known as ostarine, MK – 2866, GTx – 024, and VERU – 024) is a new type of oral, once – daily SARM. It has been evaluated in 5 clinical studies previously, covering 968 elderly normal men, post – menopausal women, and elderly patients with muscle loss due to advanced cancer. The success of this Phase 2b clinical study further validates the potential of enobosarm in muscle protection and fat loss.
Based on these positive results, Veru plans to apply to the FDA for an end – of – Phase 2 meeting and initiate a Phase 3 clinical trial. If the subsequent research goes smoothly, enobosarm is expected to become the first approved SARM drug for obese or overweight elderly patients to protect muscle mass and reduce fat while receiving GLP – 1 drug treatment. It will bring new hope to relevant patient groups and also bring new changes to the fitness and medical fields.
Post time: Feb-25-2025