About this trial
The primary objective of this study is to assess the effect of enobosarm on total body weight
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide informed consent from the subject or the subject's legally authorized representative
Be able to communicate effectively with the study personnel
Be ≥65 years of age at the time of screening
For Female Subjects Menopausal status
Disqualifiers
Known hypersensitivity or allergy to enobosarm or a GLP-1 receptor agonist
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as measured using the chronic kidney disease-epidemiology collaboration (CKD-EPI) calculation (patients with mild and moderate renal failure are not excluded from participation in this study)
Treatment with any investigational product within < 5 half-lives for each individual investigational product OR within 30 days prior to randomization
Major surgery (the surgery poses a significant risk to patients life and requires general anesthesia) within 30 days prior to randomization
Trial design
Parallel
Treatments tested in this trial
Enobosarm
DrugEnobosarm is an oral, new chemical entity class, SARM, that has demonstrated tissue-selective, dose-dependent improvement in body composition with increases in muscle mass and reduces fat mass, improves insulin resistance, has no masculinizing effects in women, has neutral prostate effects in men, and no increases in hematocrit. Increases in muscle mass have resulted in improvements in muscle strength and physical function.
Semaglutide (Wegovy) weekly injection
DrugSemaglutide for Chronic Weight Management
Treatment groups
Trial outcomes
Primary outcomes
To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.
To determine the effect of enobosarm in combination with semaglutide on total body weight compared to semaglutide alone.
Secondary outcomes
1. The percent change from baseline in total fat mass
1\. The percent change from baseline in total fat mass