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Selective Androgen Receptor Modulator
Semaglutide and Enobosarm 3 mg QD by mouth (E3G) daily for Muscle Atrophy
Phase 2
Recruiting
Research Sponsored by Veru Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 112 and day 196
Awards & highlights
Study Summary
This trial aims to see if enobosarm can increase muscle mass in patients who are already taking GLP-1 receptor agonists.
Who is the study for?
This trial is for men and women aged 60 or older who are experiencing muscle loss while managing chronic weight with a GLP-1 receptor agonist. Women must be postmenopausal, either naturally or through surgery. Participants must use effective contraception if there's any chance of pregnancy in their partners.Check my eligibility
What is being tested?
The study is testing the effects of Enobosarm on body composition, specifically lean muscle mass, in patients already taking Semaglutide for weight management. The effectiveness will be measured using DEXA scans to track changes in lean mass.See study design
What are the potential side effects?
While specific side effects aren't listed here, Enobosarm may cause symptoms like headache, nausea, fatigue, and hormonal imbalances. Semaglutide can lead to digestive issues such as nausea and diarrhea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 112 and day 196
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 112 and day 196
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days.
Secondary outcome measures
The percent change from baseline in total fat mass
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide and Enobosarm 6 mg QD by mouth (E6G) dailyExperimental Treatment2 Interventions
Approximately 30 subjects will be dosed with semaglutide injected once-weekly and enobosarm 6 mg QD by mouth (E3G) daily for approximately 112 days. Semaglutide dose escalation will occur as follows:
Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg
From Day 112 to Day 196, patients will continue to receive 6 mg enobosarm QD by mouth and will discontinue the semaglutide.
Group II: Semaglutide and Enobosarm 3 mg QD by mouth (E3G) dailyExperimental Treatment2 Interventions
Approximately 30 subjects will be dosed with semaglutide injected once-weekly and enobosarm 3 mg QD by mouth (E3G) daily for approximately 112 days. Semaglutide dose escalation will occur as follows:
Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg
From Day 112 to Day 196, patients will continue to receive 3 mg enobosarm QD by mouth and will discontinue the semaglutide.
Group III: GLP-1 receptor agonist and Placebo QD by mouth (PG) dailyPlacebo Group1 Intervention
Approximately 30 subjects will be dosed with semaglutide injected once-weekly and placebo QD by mouth (PG) daily for approximately 112 days. Semaglutide dose escalation will occur as follows:
Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg
From Day 112 to Day 196, patients will continue to receive placebo QD by mouth (PG) and will discontinue the semaglutide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160
Enobosarm
2017
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Veru Inc.Lead Sponsor
10 Previous Clinical Trials
602 Total Patients Enrolled
BarnetteStudy ChairVeru Inc.
9 Previous Clinical Trials
578 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many different medical centers can patients access this clinical trial?
"Nine patient enrollment locations for this study include Velocity Clinical Research in Los Angeles, Cullman Clinical Trials in Cullman, and Artemis Institute for Clinical Research in San Diego, among several others."
Answered by AI
Is it possible for me to participate in this medical study?
"- One year or longer duration of amenorrhea "
Answered by AI
Is the enrollment phase of this medical study currently ongoing?
"As per the details on clinicaltrials.gov, patient recruitment for this particular study is not ongoing. The trial was first listed on April 29th, 2024 and last modified on April 4th, 2024. Despite the closure of this trial to participants, there are currently over a thousand other studies actively seeking patients for enrollment."
Answered by AI
Is there an age restriction for participation in this study?
"The inclusion criteria for this trial mandate participants to be over 60 years old but under the age of 100."
Answered by AI
What are the potential risks associated with taking Semaglutide and Enobosarm at a dose of 3 mg by mouth once daily for patients?
"As this is a Phase 2 trial, the safety score for the oral administration of Semaglutide and Enobosarm at 3 mg daily has been rated as 2 by our team due to existing safety data but lacking efficacy evidence."
Answered by AI
Who else is applying?
What site did they apply to?
DelRicht Research - New Orleans
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I'm on the weekly semaglutide shot. I want to try the pills. No adverse reactions to non-medical current treatment for 3 months. Obesity only. No diabetes, but suspected insulin resistance and menopause. Glucose 100 routinely fasting.
PatientReceived 2+ prior treatments
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