Enobosarm, an oral selective androgen receptor modulator, has been shown to increase lean mass and reduce fat mass. A new analysis is particularly relevant for patients using glucagon-like peptide-1 (GLP-1) receptor agonists for weight loss. The comprehensive pooled analysis of four randomized clinical trials was conducted to assess the safety profile of enobosarm. The findings were presented in a late-breaking poster session at the American Diabetes Association Scientific Sessions in Orlando, Florida.
Methods
The analysis included data from phase 2 and phase 3 placebo-controlled clinical trials involving enobosarm. The study population was comprised of males over age 60 and 48 postmenopausal women in a phase 2 study, 651 patients with advanced lung cancer in two phase 3 studies, and 328 patients in a phase 2 study looking at stress urinary incontinence.
Results
The treatment-emergent adverse events observed with enobosarm were largely similar to those in the placebo group. The most common adverse events in patients taking enobosarm included nausea (26.6% vs. 26.0% in the placebo group), anemia (25.6% vs. 23.9%), and vomiting (14.8% vs. 14.6%). Patients who received enobosarm did not show an increased risk of gastrointestinal adverse events or drug-induced liver injury compared to those who received placebo. Additionally, the incidence of deep vein thrombosis was lower in the enobosarm group (1%) compared to the placebo group (3.3%).
Conclusion
The pooled analysis including 1,027 older men, postmenopausal women, and patients with advanced cancer–associated muscle loss demonstrated that enobosarm was well tolerated, with an adverse event profile comparable to that of placebo. Ongoing research, including a phase 2b randomized trial, aims to further evaluate the efficacy of enobosarm in older patients using GLP-1 receptor agonists for weight loss.
Jeffrey Crawford reported advisory roles with Pfizer Inc., BioAtla, G1 Therapeutics, Enzychem, and Jazz, consulting for Actimed and Faraday, and research support from Pfizer Inc., AstraZeneca, and Helsinn. Adrian S. Dobs disclosed involvement in the speaker’s bureau for Halozyme. Carla Prado reported roles in speaker’s bureaus for Abbott Nutrition, Nestlé Health Science, Nutricia, and Amra Medical, and an advisory role with Pfizer Inc. Domingo Rodriguez and Itay Shalev are employees of Veru. Mitchell Steiner is a stock/shareholder in Veru, Inc. William J. Evans and K. Gary Barnette reported no disclosures.