RENEW-ALC-1

RecruitingPhase 3

A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder

A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

117

Recruiting sites

Estimated enrollment

1,100

Study population

Alcohol / substance use

Eligibility highlights

Primary endpoint

•Drinking Patterns in Alcohol Use Disorder (AUD)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07219966

Org study ID27346

Secondary ID2025

Secondary ID2025-522313-38-00

Secondary IDJ2S-MC-GZMEEli Lilly and Company

Timeline

Milestones

Study start2025-10-15actual

Study first posted2025-10-22actual

Last update posted2026-10-07actual

Primary completion2028-04estimated (month precision)

Study completion2028-04estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

Alcohol / substance use

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participant must be a minimum of 20 years of age for the investigative sites in Japan.

•Are seeking treatment and are motivated to stop or cut down on drinking.

•Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as

-self-inject study intervention

-store and use the provided blinded study intervention, as directed

-maintain electronic and paper study diaries, as applicable, and

-complete the required questionnaires.

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 as indicated by clinical interview, 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

•Have either of the following:

-history of advanced liver disease, including advanced liver fibrosis [Stage 3] or cirrhosis [Stage 4], based on prior biomarkers, imaging or liver biopsy, OR

-history of acute alcohol-associated hepatitis based on prior liver biopsy.

•Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Weight & body composition

Patient-reported / QoL

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Mean Change in Body Weight

Time frame:Baseline up to Week 56

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Mean Change in Patient Reported Health Outcomes as Measured by Short Form 36, v2 (SF-36) Acute Form Domain and Component Summary Scores

Time frame:Baseline up to Week 56

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

Time frame:Baseline up to Week 56

concentration, descriptive

Secondary/protocol endpoint

Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA)

Time frame:Baseline up to Week 56

event count, event

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)

Time frame:Up to 56 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Daily Alcohol Consumption as Assessed by the TLFB

Time frame:Up to 56 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)

Time frame:Baseline up to Week 56

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score

Time frame:Baseline up to Week 56

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.