NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Alcohol Use Disorder
Date of first enrollment	06/02/2026
Target sample size	1100
Countries of recruitment	United States,Japan,Argentina,Japan,Belgium,Japan,China,Japan,Germany,Japan,South Korea,Japan,Taiwan,Japan,United Kingdom,Japan
Study type	Interventional
Intervention(s)	DRUG: LY3537031(Other Name: Brenipatide) Administered SC DRUG: Placebo Administered SC (Study Arms) Experimental: LY3537031 Period 1 Escalating doses administered subcutaneously (SC) Interventions: Drug: LY3537031 Drug: Placebo Experimental: LY3537031 Period 2 Administered SC Interventions: Drug: LY3537031 Drug: Placebo Placebo Comparator: Placebo Administered SC Interventions: Drug: Placebo

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 75age old
Gender	Both
Include criteria	- 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.
Exclude 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 a history of advanced liver disease (including advanced liver fibrosis or cirrhosis), or alcohol-associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score. - 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).