Brenipatide for Alcoholism

(RENEW-ALC-1 Trial)

Not yet recruiting at 125 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Substance use disorder, Suicidal ideation, Advanced liver disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment, brenipatide, for individuals with moderate-to-severe Alcohol Use Disorder (AUD). Researchers aim to determine whether brenipatide can reduce or stop alcohol consumption compared to a placebo (inactive substance). The trial includes two experimental groups receiving different doses of brenipatide and one placebo group. Suitable candidates for this trial are those motivated to reduce or stop drinking and committed to attending study visits and completing study tasks. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that brenipatide is likely to be safe for humans?

Research has shown that Brenipatide may help treat alcohol use disorder. In earlier studies, most participants tolerated Brenipatide well, with side effects typically mild, such as headaches or nausea. Serious side effects were rare.

This trial is in a later stage, indicating that Brenipatide has already passed initial safety tests. For those considering joining the trial, this suggests Brenipatide is likely safe for most people. It is important to consult a doctor if there are concerns about side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Brenipatide is unique because it offers a new approach to treating alcoholism by using escalating doses administered subcutaneously. Unlike standard treatments like naltrexone or acamprosate, which are typically taken orally, Brenipatide's delivery method might enhance its effectiveness and patient adherence. It potentially targets alcohol dependence in a novel way, which has researchers excited about its promise to offer more rapid and possibly more robust results in combating alcoholism.

What evidence suggests that brenipatide might be an effective treatment for Alcohol Use Disorder?

Studies have shown that brenipatide may reduce the urge to drink and the amount of alcohol consumed by people with Alcohol Use Disorder (AUD). Research indicates that individuals taking brenipatide reported fewer days of heavy drinking compared to those not taking the drug. Early findings suggest that brenipatide affects brain pathways related to addiction, potentially lowering alcohol use. Although more information is needed, these initial results are promising for those struggling with moderate-to-severe AUD. Participants in this trial will receive either escalating doses of brenipatide, a consistent dose, or a placebo, administered subcutaneously. ^{2 3 6 7 8}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for individuals with moderate-to-severe Alcohol Use Disorder (AUD), who may also be experiencing alcohol-related intimate partner violence. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and cannot have conditions that would interfere with the study.

Inclusion Criteria

I want to reduce or stop my alcohol consumption.

I am committed to attending all study visits, self-injecting medication, and keeping detailed records as required.

Exclusion Criteria

Positive response to specific questions on the Columbia-Suicide Severity Rating Scale within the past 6 months

Evidence of history of any substance use disorder(s) with persistent illicit or nonprescribed substance use, except alcohol, nicotine, or caffeine

I have a history of severe liver disease or alcohol-related liver problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of brenipatide or placebo administered subcutaneously

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brenipatide

Trial Overview The study is testing brenipatide against a placebo to determine its effectiveness and safety in treating AUD. Participants will either receive the experimental drug LY3537031 or a placebo for about 56 weeks to compare outcomes.

How Is the Trial Designed?

Group I: LY3537031 Period 2 Experimental Treatment 2 Interventions

Administered SC

Group II: LY3537031 Period 1 Experimental Treatment 2 Interventions

Escalating doses administered subcutaneously (SC)

Group III: Placebo Placebo Group 1 Intervention

Administered SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07219953

A Study of Brenipatide in Participants With Alcohol Use ... The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with Alcohol Use Disorder (AUD) and ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07219966

UCSF Alcohol Use Trial → Brenipatide in Participants With ... The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe ...

3. patlynk.com patlynk.com/trial/NCT07219953

Brenipatide for Alcohol Use Disorder Treatment The goal is to gather clear evidence on whether brenipatide can be a safe and effective option for treating AUD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12238138/

Investigating Therapeutic Targets for Alcohol Use Disorder Common outcome measures in AUD clinical trials primarily focused on behavioral and physiological indicators of alcohol use. Craving scores were ...

5. withpower.com withpower.com/trial/phase-3-alcoholism-11-2025-47e85

Brenipatide for Alcoholism (RENEW-ALC-1 Trial) The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07219966

NCT07219966 | A Study of Brenipatide in Participants With ... The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe ...

7. tipranks.com tipranks.com/news/company-announcements/eli-lillys-new-study-on-brenipatide-a-potential-game-changer-for-alcohol-use-disorder

Eli Lilly's New Study on Brenipatide: A Potential Game ... The study aims to evaluate the effectiveness and safety of brenipatide in treating adults with Alcohol Use Disorder (AUD) and hazardous alcohol ...

8. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/35641254/eli-lillys-new-phase-3-study-a-potential-game-changer-for-alcohol-use-disorder/

Eli Lilly's New Phase 3 Study: A Potential Game-Changer ... The study aims to evaluate the effectiveness and safety of brenipatide in treating adults with moderate-to-severe Alcohol Use Disorder (AUD), a ...