Veru Inc. has announced positive topline results from its Phase 2b QUALITY clinical study, revealing that its investigational drug, enobosarm, significantly preserves lean mass in older patients taking Novo Nordisk's Wegovy (semaglutide) for weight loss. The study addresses a critical issue associated with GLP-1 receptor agonists: the loss of lean mass, which can lead to frailty and functional decline, especially in older adults.
The Phase 2b trial, a placebo-controlled dose-finding study, involved 168 patients over 60 years of age who were overweight or obese. Participants were administered either 3mg or 6mg of enobosarm, or a placebo, in conjunction with Wegovy. The primary endpoint was the change in total lean body mass from baseline to 16 weeks.
Key Findings from the QUALITY Trial
The study met its primary endpoint, demonstrating a statistically significant benefit in the preservation of total lean body mass in patients receiving enobosarm plus semaglutide compared to those receiving placebo plus semaglutide at 16 weeks. Specifically, patients taking enobosarm in addition to Wegovy lost an average of 1.2% of their lean mass, while those on Wegovy alone lost 4.1% (p=0.002).
Secondary endpoints also revealed positive outcomes:
- Fat Mass Reduction: Enobosarm plus semaglutide treatment resulted in a greater reduction in total fat mass compared to placebo plus semaglutide at 16 weeks.
- Physical Function: A statistically significant and clinically meaningful reduction was observed in the proportion of subjects experiencing a 10% or greater decline in stair climb power in the enobosarm plus semaglutide groups compared to the placebo plus semaglutide group. Only 19.4% of patients on enobosarm experienced this decline, compared to 42.6% in the placebo arm.
According to Veru, the blinded safety data from the ongoing clinical study has not shown significant differences compared to previous enobosarm studies.
Addressing Unmet Needs in Obesity Treatment
Veru's CEO, Mitchell Steiner, emphasized the importance of preserving lean mass during weight loss, particularly in older patients. He noted that GLP-1 receptor agonists like Wegovy can cause significant lean mass loss, potentially leading to mobility issues, balance problems, and increased risk of disability. Enobosarm, a selective androgen receptor modulator (SARM), aims to mitigate this issue by improving body composition during weight loss.
Future Directions for Enobosarm
Veru plans to meet with the FDA to discuss the path forward for enobosarm, with a focus on designing a Phase 3 program. The company envisions a similar trial design to the Phase 2b study, but with approximately 470 patients and a 52-week duration. Stair-climb power is expected to be the primary endpoint in the Phase 3 trial.
The development of enobosarm comes as the biopharmaceutical industry increasingly focuses on improving the quality of weight loss, aiming to help patients lose fat mass while preserving muscle mass. Other companies, such as Regeneron and Altimmune, are also exploring strategies to address this unmet need in obesity treatment.
