Enobosarm + Semaglutide for Obesity

(PLATEAU Trial)

Recruiting at 8 trial locations

Overseen By Domingo Rodriguez

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: Veru Inc.

Must be taking: Semaglutide

Must not be taking: Testosterone, Antiandrogens

Disqualifiers: Diabetes, Liver disease, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 68 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Barnette

Principal Investigator

Veru Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I need semaglutide for weight loss as advised by my doctor.

I agree to take semaglutide for up to 476 days.

I am able to swallow pills or oral medications.

Exclusion Criteria

I have high blood pressure that is not well controlled.

I have diabetes and take medication or my HbA1c is 6.5% or higher.

I have had a tendon rupture or take medicines that increase tendon rupture risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide subcutaneous injection plus oral enobosarm or placebo for weight reduction

68 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Enobosarm
• Semaglutide

How Is the Trial Designed?

Group I: Subcutaneous injectable semaglutide and oral enobosarm 3mg Experimental Treatment 2 Interventions

Approximately 100 subjects will be dosed for 476 days with semaglutide subcutaneous injection plus oral enobosarm 3 mg QD

Group II: Subcutaneous injectable semaglutide and oral Placebo Placebo Group 1 Intervention

Approximately 100 subjects will be dosed with semaglutide subcutaneous injection plus matching placebo

Who Is Running the Clinical Trial?

Veru Inc.

Lead Sponsor

Trials

11

Recruited

750+