A Phase 3 interventional study of LY3537031 and Placebo in Alcohol Use Disorder, sponsored by Eli Lilly and Company. Recruiting at 116 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
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
Exclusion Criteria:
Have either of the following:
Escalating doses administered subcutaneously (SC)
Drug: LY3537031 · Drug: Placebo
Administered SC
Drug: LY3537031 · Drug: Placebo
Administered SC
Drug: Placebo
Administered SC
Also known as: Brenipatide
Administered SC
Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Time frame: Up to 56 weeks
Change in Daily Alcohol Consumption as Assessed by the TLFB
Time frame: Up to 56 weeks
Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)
Time frame: Baseline up to Week 56
Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Time frame: Baseline up to Week 56
Mean Change in Body Weight
Time frame: Baseline up to Week 56
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
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Baseline up to Week 56
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Time frame: Baseline up to Week 56
Showing the first 100 of 116 sites across 8 countries.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
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Eli Lilly and Company