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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65-100
SponsorVeru Inc.

About this trial

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

Eligibility criteria

Qualifiers

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

Treatments tested in this trial

  • Enobosarm
  • Semaglutide (Wegovy) weekly injection

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

14
Arizona
DM Clinical Research - Phoenix85012, Phoenix United States
Florida
DM Clinical Research - MIA33166, Doral United States
Universal Axon Clinical Research (Rovia - UACR)33166, Doral United States
IMIC Research a Rovia Clinical Research Company33176, Miami United States

Sponsors and collaborators

Veru Inc.

Lead sponsor