NCT07219953 (RENEW-ALC-2) is a Phase 3 clinical trial of LY3537031 in Alcohol Use Disorder, sponsored by Eli Lilly and Company.

Who is sponsoring NCT07219953?

NCT07219953 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT07219953?

Interventions in NCT07219953: LY3537031, Placebo.

What condition does NCT07219953 study?

NCT07219953 studies Alcohol Use Disorder.

Is NCT07219953 still recruiting?

NCT07219953 is currently recruiting now. Last updated 2 June 2026.

Last reviewed 2026-06-02 · How we verify

NCT07219953: RENEW-ALC-2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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 Alcohol Use Disorder (RENEW-ALC-2)

Recruiting now Phase 3 Last updated 2 June 2026

What this trial tests

Phase 3 trial testing LY3537031 in Alcohol Use Disorder in 1,100 participants. Currently enrolling.

Timeline

16 October 2025

Primary endpoint
1 April 2028

1 April 2028

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,100
Start date	16 October 2025
Primary completion	1 April 2028
Estimated completion	1 April 2028
Sites	119 locations across United States, Belgium, China, Germany, Japan, South Korea, Taiwan, United Kingdom

Drugs / interventions tested

LY3537031 — full drug profile →
Placebo

Conditions studied

Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 75, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Time frame: Up to 56 weeks

Sponsor's own description

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 hazardous alcohol use. Participation in this study will last approximately 56 weeks.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

GLP-1 Receptor Agonists for Treating Alcohol Use Disorder: A Critical Review.
Woo S, Zhu G, Castro C, Phuong A, et al · · 2026 · PMID 42144979 · DOI 10.1111/acer.70312
Glucagon-like peptide 1 receptor agonists in substance use disorders: A systematic review of ClinicalTrials.Gov.
Patil S, Jha N, Jha MK. · · 2026 · PMID 41696398 · DOI 10.1016/j.abrep.2026.100671

Verify or expand the search:

Other trials of LY3537031

Trials testing the same drug.

NCT04648865 — A Study of LY3537031 in Healthy Participants · Phase 1 · completed

Other recruiting trials for Alcohol Use Disorder

Currently open trials in the same condition.

NCT06860607 — Environment and Alcohol: A Pilot Study · Phase 1 · recruiting
NCT07325266 — Human Laboratory Study of Apremilast for Alcohol Use Disorder · Phase 2 · recruiting
NCT07046819 — Tirzepatide in MetALD · Phase 2 · recruiting
NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting
NCT07056894 — Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis · NA · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07219953 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 2 June 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07219953.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing