Brenipatide for Alcoholism

(RENEW-ALC-2 Trial)

Recruiting at 123 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

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether brenipatide, an experimental drug, is effective and safe for individuals with Alcohol Use Disorder (AUD) who drink in risky amounts. The study compares brenipatide to a placebo to determine its effectiveness in reducing drinking. Participants will be involved for about 56 weeks. This trial suits those who wish to reduce or stop drinking and are willing to self-inject or have assistance with injections. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment for AUD.

Will I have to stop taking my current medications?

The trial information does not specify if 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 has been tested in people to assess its safety. In earlier studies, most participants tolerated brenipatide well. The side effects were usually mild and short-lived. Some experienced mild pain or redness at the injection site. These studies found no major safety issues. As a Phase 3 trial, brenipatide has already passed earlier tests demonstrating its safety for larger groups. This suggests that brenipatide is considered safe for individuals with Alcohol Use Disorder (AUD). ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Researchers are excited about Brenipatide because it offers a fresh approach to treating alcoholism. While most current options, like naltrexone and acamprosate, focus on reducing cravings or managing withdrawal symptoms, Brenipatide might work differently by targeting specific neural pathways involved in addiction. Administered subcutaneously, it could potentially offer a more direct and efficient delivery compared to oral medications. This novel mechanism and delivery method have the potential to significantly impact how we treat alcoholism, making it a promising addition to existing therapies.

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

Research has shown that brenipatide may help people with Alcohol Use Disorder (AUD). Studies have found that brenipatide can lessen the urge to drink in those with moderate-to-severe AUD. Early results suggest that brenipatide affects brain pathways related to addiction, potentially helping people reduce their drinking. In this trial, participants will receive either escalating doses of brenipatide or a placebo. Overall, the evidence so far appears promising for brenipatide as a potential treatment for those struggling with AUD. ^{1 2 3 4 6}

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 Alcohol Use Disorder (AUD) who engage in hazardous alcohol use. The study will last about 56 weeks, but specific eligibility criteria are not provided.

Inclusion Criteria

I want to stop or reduce my drinking.

I am committed to attending all study visits for the duration of the trial.

I can follow the study's rules, do or get help with self-injections, and keep a diary.

Exclusion Criteria

Have evidence of current or within the past 180 days prior to screening (V1) history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use, except alcohol, nicotine, or caffeine

Have answered 'yes' to either Question 4 or Question 5 on the 'Suicidal Ideation' portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or have answered 'yes' to any of the suicide-related behaviors on the 'Suicidal Behavior' portion of the C-SSRS and the behavior occurred within the past 6 months

I have advanced liver disease or alcohol-related hepatitis, confirmed by tests.

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 the effectiveness and safety of a medication called Brenipatide compared to a placebo in treating AUD. Participants will be randomly assigned to receive either Brenipatide or a placebo.

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. 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 ...

4. 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 ...

5. patlynk.com patlynk.com/trial/NCT07219953

Brenipatide for Alcohol Use Disorder Treatment The study is focused on understanding if a medication called brenipatide is effective and safe for adults dealing with Alcohol Use Disorder ...

6. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/35641256/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 ...