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
6 states
Healthy volunteers
No
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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.
- ✕ 7. An abnormal ECG result which, based on the investigator's clinical judgment, would place the subject at increased medical risk. A QTcF \>450 ms for males and \>450 ms for females is also exclusionary from this protocol.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07446998 · last updated 2026-04-22