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Background: Enobosarm is a novel oral selective androgen receptor modulator shown to increase lean mass and decrease fat mass. Enobosarm may benefit patients on GLP-1 RA for weight loss by preserving muscle while augmenting fat loss. A pooled analysis was conducted from 4 randomized clinical trials (RCT) to evaluate the safety profile of enobosarm. Methods: The pooled safety analysis of enobosarm (3mg) included: Ph2 study in older males (60 yo) and postmenopausal women (n=48), two Ph3 studies in patients with advanced lung cancer (n=651), and a Ph2 stress urinary incontinence study (n=328). Results: TEAEs observed with enobosarm were comparable to the placebo group. Most common AEs for enobosarm were nausea (26.6% vs 26.0% in placebo), anemia (25.6% vs 23.9% in placebo), and vomiting (14.8% vs 14.6% in placebo), which were similar to the placebo groups. Notably, there was no increase in gastrointestinal AEs and no evidence of drug induced liver injury with enobosarm compared to placebo treatment. The incidence of deep vein thrombosis was higher (3.3%) in placebo compared to the enobosarm group (1%). Conclusion: In pooled analysis of 1027 older men, postmenopausal women, and older patients with muscle loss from advanced cancer, enobosarm was well tolerated with an AE profile comparable to the control patients. A Ph2b randomized trial is underway to evaluate enobosarm in older patients on a GLP-1 RA for weight loss. Disclosure J. Crawford: Advisory Panel; Pfizer Inc. Research Support; Pfizer Inc., AstraZeneca, helsinn. Advisory Panel; BioAtla. Consultant; Actimed. Advisory Panel; G1 Therapeutics, Enzychem. Consultant; Faraday. Advisory Panel; Jazz. A.S. Dobs: Speaker's Bureau; Halozyme. W.J. Evans: None. C. Prado: Speaker's Bureau; Abbott Nutrition, Nestlé Health Science, Nutricia, Amra medical. Advisory Panel; Pfizer Inc. D. Rodriguez: Employee; Veru. I. Shalev: Employee; Veru. K. Barnette: None. M. Steiner: Stock/Shareholder; Veru, Inc.
Crawford et al. (Fri,) studied this question.