PLATEAU: Phase 2b Proof-of-Concept Study to Evaluate the Effect on Total Body Weight, Physical Function and Safety of Enobosarm in Patients Treated With Semaglutide, a Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist, for Weight Reduction
Veru Inc.
Summary
The primary objective of this study is to assess the effect of enobosarm on total body weight
Description
This study is a multicenter, randomized, double-blind, and placebo-controlled study. Subjects will be randomized into two treatment arms (subcutaneous injectable semaglutide plus oral enobosarm 3mg dose group or subcutaneous injectable semaglutide plus placebo group) in a 1:1 fashion. All patients randomized into this study will initiate semaglutide subcutaneous injection therapy for weight reduction on Day 1 of this study. The primary efficacy endpoint of the study will be the percent change from baseline in total body weight at 68 weeks (476 days). A safety follow up visit will occur approx…
Eligibility
- Age range
- 65–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Be premenopausal or perimenopausal with a negative pregnancy test. * If subject is of child bearing potential, the subject must agree to use acceptable met…
Interventions
- DrugEnobosarm
Enobosarm 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.
- DrugSemaglutide (Wegovy) weekly injection
Semaglutide for Chronic Weight Management
Locations (10)
- DM Clinical Research - PhoenixPhoenix, Arizona
- DM Clinical Research - MIADoral, Florida
- Universal Axon Clinical Research (Rovia - UACR)Doral, Florida
- Paramo HealthMiami, Florida
- IMIC Research a Rovia Clinical Research CompanyMiami, Florida
- Paramo HealthMiami, Florida