Enobosarm for Muscle Atrophy

(QUALITY Trial)

No longer recruiting at 15 trial locations

Overseen By Steven Geller, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Veru Inc.

Must be taking: GLP-1 receptor agonists

Must not be taking: Testosterone, Antiandrogens

Disqualifiers: Diabetes, Liver disease, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how enobosarm, a new treatment classified as a selective androgen receptor modulator, affects muscle mass in individuals using GLP-1 receptor agonists, commonly prescribed for weight management. The study will test two different doses of enobosarm alongside semaglutide, a common GLP-1 receptor agonist, and compare them with a placebo. It seeks participants with obesity (BMI of 30 or more, or 27 with conditions like high blood pressure or type 2 diabetes), who are medically advised to use a GLP-1 receptor agonist, and can complete a stair climb test. Participants should not have recently used GLP-1 receptor agonists or have certain health conditions, such as severe liver disease or recent major surgery. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must not be on certain medications like testosterone or GLP-1 receptor agonists before joining. If you were on testosterone, a 30-day period without it is required before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that enobosarm is generally safe for people. One study combined enobosarm with semaglutide and found it had a good safety profile, with most participants not experiencing serious side effects. Another review analyzed data from four different studies and found that enobosarm is well-tolerated.

Most side effects were not serious. Although some participants experienced worsening of existing cancers, this was rare. Overall, enobosarm appears safe for most people in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for muscle atrophy, which often involve physical therapy and nutritional support, Enobosarm is unique because it targets androgen receptors to stimulate muscle growth directly. This selective androgen receptor modulator (SARM) is taken orally, potentially offering a more convenient alternative to injectable therapies. Researchers are excited about Enobosarm because it promises a targeted approach that could enhance muscle mass and function with fewer side effects compared to traditional anabolic steroids.

What evidence suggests that this trial's treatments could be effective for muscle atrophy?

Research has shown that enobosarm can increase muscle mass. In several studies, participants taking enobosarm gained about 1.5 kg more muscle than those on a placebo, marking a significant difference. This trial will test enobosarm combined with semaglutide, with participants receiving either 3 mg or 6 mg of enobosarm daily. This treatment also avoids the harmful side effects often seen with similar drugs. Enobosarm has been tested in older men and women, showing promising results in building muscle and reducing fat. Overall, these findings suggest that enobosarm could effectively treat muscle loss. ^{1 6 7 8 9}

Who Is on the Research Team?

Barnette

Principal Investigator

Veru Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Documented evidence of obesity (BMI ≥30 or ≥27 with the presence of at least one weight-related comorbid condition)

Maximum weight at screening of 300lbs as per DEXA requirements

Complete a valid OSA assessment

Exclusion Criteria

I do not have any health issues that prevent me from using semaglutide.

Baseline total bilirubin levels > upper limit of normal

Concurrently participating in any other interventional or treatment clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide and enobosarm or placebo for approximately 16 weeks with dose escalation of semaglutide

16 weeks

Weekly visits for semaglutide dose escalation

Monotherapy Treatment

Participants continue enobosarm or placebo monotherapy from Day 112 to Day 196 after discontinuation of semaglutide

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 safety follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Enobosarm

Trial Overview 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.

How Is the Trial Designed?

Group I: Semaglutide and Enobosarm 6 mg QD by mouth (E6G) daily Experimental Treatment 2 Interventions

Approximately 50 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) daily Experimental Treatment 2 Interventions

Approximately 50 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) daily Placebo Group 1 Intervention

Approximately 50 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.

Who Is Running the Clinical Trial?

Veru Inc.

Lead Sponsor

Trials

11

Recruited

750+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4898053/

Effects of enobosarm on muscle wasting and physical function ... Our results provide evidence that a targeted anabolic agent can increase lean body mass in conjunction with improved physical function and quality of life ...

2. ir.verupharma.com ir.verupharma.com/news-events/press-releases/detail/189/veru-reports-muscle-data-from-5-clinical-studies-of

Press Releases Enobosarm treatment in elderly men and postmenopausal women with and without active muscle wasting consistently resulted in the reduction in fat ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23499390/

Effects of enobosarm on muscle wasting and physical function ... Our data suggest that use of enobosarm might lead to improvements in lean body mass, without the toxic effects associated with androgens and progestational ...

4. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/2066-LB/155756/2066-LB-Potential-to-Optimize-Weight-Loss-with

2066-LB: Potential to Optimize Weight Loss with Enobosarm ... Results: At Day 84, DXA scan showed an absolute increase in lean mass of 1.5 kg in enobosarm treated vs placebo (p=0.00004) and % change in lean ...

5. ir.verupharma.com ir.verupharma.com/news-events/press-releases/detail/222/veru-announces-meta-analysis-of-body-composition-data-from

Veru Announces Meta-analysis of Body Composition Data ... Meta-analysis shows in older subjects with obesity that enobosarm 3mg daily treatment resulted in DEXA body composition changes of greater total weight loss by ...

6. ir.verupharma.com ir.verupharma.com/news-events/press-releases/detail/234/veru-reports-positive-safety-results-from-phase-2b-quality

Enobosarm Added to Semaglutide Led to Greater Fat Loss ... Phase 2b QUALITY clinical study topline safety data shows that the enobosarm + semaglutide combination had a positive safety profile ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3177038/

The selective androgen receptor modulator GTx-024 ... Muscle wasting is associated with cancer, sarcopenia, chronic obstructive pulmonary disease, end-stage renal disease, and other chronic conditions and results ...

8. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/2067-LB/155755/2067-LB-Pooled-Safety-Analysis-of-Enobosarm-from

2067-LB: Pooled Safety Analysis of Enobosarm from Phase 2 ... A pooled analysis was conducted from 4 randomized clinical trials (RCT) to evaluate the safety profile of enobosarm. Methods: The pooled safety ...

9. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00004-4/fulltext

Activity and safety of enobosarm, a novel, oral, selective ... Our results show that enobosarm, an oral SARM, results in clinical benefit and a progression-free survival that is acceptable for the line of ...