Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Phase 3

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

NCT07219966 · tracked via the Priya Life Science Taiwan tracker
Phase
Phase 3
Started
2025-10-15
Last updated
2026-10-07

Condition(s) studied

Alcohol Use Disorder

Investigational drug(s) / intervention(s)

LY3537031 →Placebo

LY3537031: Administered SC

Placebo: Administered SC

Study summary

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 Disorder (AUD). Participation in this study will last approximately 56 weeks.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

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

Trial sites (117)

FacilityCityRegionStatus
Parkway Medical Center Birmingham Alabama Completed
Headlands Research - Scottsdale Scottsdale Arizona Active Not Recruiting
Woodland International Research Group Little Rock Arkansas Completed
UCLA Clinical & Translational Research Center (CTRC) Los Angeles California Active Not Recruiting
Artemis Institute for Clinical Research San Diego California Active Not Recruiting
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay San Francisco California Active Not Recruiting
Mountain Mind - Denver Denver Colorado Active Not Recruiting
Accel Research Sites - Lakeland Clinical Research Unit Lakeland Florida Active Not Recruiting
K2 Medical Research - Maitland Maitland Florida Active Not Recruiting
K2 Medical Research ORLANDO Maitland Florida Active Not Recruiting
Life Arc Research Centers - Miami Miami Florida Active Not Recruiting
Wellness Research Center Miami Florida Active Not Recruiting
Life Medical Research Group Corp Miami Gardens Florida Active Not Recruiting
Charter Research - Orlando Orlando Florida Active Not Recruiting
K2 Medical Research - Tampa Tampa Florida Active Not Recruiting
Re:Cognition Health - Chicago Chicago Illinois Active Not Recruiting
Maryland Treatment Centers - Mountain Manor Treatment Center Baltimore Maryland Active Not Recruiting
Maryland Treatment Centers - Avery Road Treatment Center Rockville Maryland Recruiting
Adams Clinical Boston Boston Massachusetts Active Not Recruiting
K2 Medical Research - Foxborough Foxborough Massachusetts Active Not Recruiting
Adams Clinical Bronx The Bronx New York Active Not Recruiting
North Star Medical Research Middleburg Heights Ohio Completed
Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania Active Not Recruiting
Avera Research Institute - Sioux Falls Sioux Falls South Dakota Active Not Recruiting
UT Southwestern Medical Center Dallas Texas Recruiting
Adams Clinical Dallas DeSoto Texas Active Not Recruiting
Pillar Clinical Research - Richardson Richardson Texas Active Not Recruiting
Alpine Research Organization Clinton Utah Active Not Recruiting
Re:Cognition Health Fairfax Virginia Active Not Recruiting
University of Washington Medical Center - Montlake Seattle Washington Active Not Recruiting
ANIMA Research Diepenbeek Belgium Active Not Recruiting
Kormont Kluisbergen Belgium Active Not Recruiting
Gezondheidshuis De Gloed Machelen Belgium Active Not Recruiting
Meclinas Mechelen Belgium Active Not Recruiting
Medisch Centrum Saffrou Oudenaarde Belgium Active Not Recruiting
Beijing Anding Hospital - Affiliated Capital University of Medical Science Beijing China Active Not Recruiting
Beijing HuiLongGuan Hospital Beijing China Active Not Recruiting
The Second People's Hospital of Hunan Province Changsha China Active Not Recruiting
The Second Xiangya Hospital of Central South University Changsha China Active Not Recruiting
West China Hospital, Sichuan University Cheng Du Shi China Active Not Recruiting

+ 77 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07219966 on ClinicalTrials.gov ↗ ← All trials in Taiwan