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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Enobosarm

    Drug

    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.

  • Semaglutide (Wegovy) weekly injection

    Drug

    Semaglutide for Chronic Weight Management

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Subcutaneous injectable semaglutide and oral enobosarm 3mgExperimental treatment 2 interventions
Group B: Subcutaneous injectable semaglutide and oral PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 476

Secondary outcomes

1

1. The percent change from baseline in total fat mass

1\. The percent change from baseline in total fat mass

Time frame
Day 476

Other outcomes

Sponsors and contacts

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