RecruitingObesity & OverweightMobility DisabilityHOMA-IR

Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss

Eligible age

65–100 yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

The primary objective of this study is to assess the effect of enobosarm on total body weight

Sponsor: Veru Inc.

You may qualify if…

✓ Subjects accepted for this study must:
✓ 1. Provide informed consent from the subject or the subject's legally authorized representative
✓ 2. Be able to communicate effectively with the study personnel
✓ 3. Be ≥65 years of age at the time of screening
✓ 4. For Female Subjects Menopausal status
✓ Be postmenopausal as defined by either:
✓ one year or more of amenorrhea
✓ surgical menopause with bilateral oophorectomy

You may not qualify if…

✕ Any of the following conditions are cause for exclusion from the study:
✕ 1. Known hypersensitivity or allergy to enobosarm or a GLP-1 receptor agonist
✕ 2. 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)
✕ 3. Treatment with any investigational product within \< 5 half-lives for each individual investigational product OR within 30 days prior to randomization
✕ 4. Major surgery (the surgery poses a significant risk to patients life and requires general anesthesia) within 30 days prior to randomization
✕ 5. Planned major surgery during the course of the study or any cosmetic surgery potentially impacting body composition, e.g., liposuction, implants, or removal of any current implants
✕ 6. Testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), myostatin inhibitors, apelin receptor agonists, or antiandrogens (flutamide, bicalutamide, abiraterone, enzalutamide, apalutamide, or darolutamide).
✕ Previous therapy with testosterone and testosterone-like agents is acceptable with a 30-day washout (if previous testosterone therapy was long term depot within the past 6 months, the site should contact the Medical Monitor) or any other androgenic agent.