Actively Recruiting
A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for Adult Participants With Alcohol Use Disorder
Led by Eli Lilly and Company · Updated on 2026-06-03
1100
Participants Needed
119
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. The study aims to assess the drug's effect on drinking patterns and its safety. This phase 3, randomized, double-blind trial is sponsored by Eli Lilly and Company and will last about 56 weeks. Participants receive escalating doses of brenipatide or placebo, administered as subcutaneous injections. The study includes a multi-period design with two experimental periods for brenipatide dosing and a placebo group. Participants or trained support persons will perform self-injections, and the study medication is blinded to ensure unbiased results. Throughout the trial, participants will attend regular visits for assessments including drinking behavior using the Timeline Followback Method, alcohol craving scales, health questionnaires, and body weight measurements. Blood samples will be taken to analyze drug levels and immune response. Participants will keep diaries and complete questionnaires to monitor adherence and effects. Safety and tolerability will be closely monitored during the 56-week participation period.
CONDITIONS
Brief Title
A Study of Brenipatide in Participants With Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be at least 20 years old for sites in Japan
- Seeking treatment and motivated to stop or reduce drinking
- Willing and able to self-inject study medication or have trained support to help
- Able to attend all required study visits and follow study procedures including diaries and questionnaires
You will not qualify if you...
- History or current substance use disorder other than alcohol, nicotine, or caffeine within 180 days before screening
- Suicidal thoughts or behaviors within the last 6 months based on Columbia-Suicide Severity Rating Scale
- History of advanced liver disease or alcohol-related hepatitis
- Participation in another clinical trial with active treatment within 90 days or 5 half-lives before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 56 weeks
Participants receive escalating doses of the study drug or placebo administered subcutaneously.
Regular visits for dosing and assessments during treatment period
Trial Site Locations
Total: 119 locations
1
Headlands Research - Scottsdale
Scottsdale, Arizona, United States, 85260
Actively Recruiting
2
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California, United States, 90095
Actively Recruiting
4
Artemis Institute for Clinical Research
Riverside, California, United States, 92503
Actively Recruiting
5
Artemis Institute for Clinical Research
San Diego, California, United States, 92123
Actively Recruiting
6
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
7
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, United States, 33803
Actively Recruiting
8
Innovative Clinical Research
Lauderhill, Florida, United States, 33319
Not Yet Recruiting
9
K2 Medical Research - Maitland
Maitland, Florida, United States, 32751
Actively Recruiting
10
K2 Medical Research ORLANDO
Maitland, Florida, United States, 32751
Actively Recruiting
11
Life Arc Research Centers - Miami
Miami, Florida, United States, 33126
Actively Recruiting
12
Wellness Research Center
Miami, Florida, United States, 33135
Actively Recruiting
13
Life Medical Research Group Corp
Miami Gardens, Florida, United States, 33014
Actively Recruiting
14
Charter Research - Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
15
K2 Medical Research - Tampa
Tampa, Florida, United States, 33634
Actively Recruiting
16
Re:Cognition Health - Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
17
Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland, United States, 21229
Actively Recruiting
18
Maryland Treatment Centers - Avery Road Treatment Center
Rockville, Maryland, United States, 20853
Actively Recruiting
19
Adams Clinical Boston
Boston, Massachusetts, United States, 02116
Actively Recruiting
20
K2 Medical Research - Foxborough
Foxborough, Massachusetts, United States, 02035
Actively Recruiting
21
Adams Clinical Bronx
The Bronx, New York, United States, 10461
Actively Recruiting
22
North Star Medical Research
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
23
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
24
Brown University School of Public Health
Providence, Rhode Island, United States, 02903
Actively Recruiting
25
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
26
Modern Research Associates, PLLC
Dallas, Texas, United States, 75231
Actively Recruiting
27
Adams Clinical Dallas
DeSoto, Texas, United States, 75115
Actively Recruiting
28
Biopharma Informatic, LLC
Houston, Texas, United States, 77043
Actively Recruiting
29
Re:Cognition Health
Fairfax, Virginia, United States, 22031
Actively Recruiting
30
ANIMA Research
Diepenbeek, Belgium, 3590
Actively Recruiting
31
Kormont
Kluisbergen, Belgium, 9690
Actively Recruiting
32
Gezondheidshuis De Gloed
Machelen, Belgium, 9870
Actively Recruiting
33
Meclinas
Mechelen, Belgium, 2800
Actively Recruiting
34
Medisch Centrum Saffrou
Oudenaarde, Belgium, 9636
Actively Recruiting
35
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, China, 100088
Actively Recruiting
36
Beijing HuiLongGuan Hospital
Beijing, China, 100096
Actively Recruiting
37
The Second People's Hospital of Hunan Province
Changsha, China, 410007
Actively Recruiting
38
The Second Xiangya Hospital of Central South University
Changsha, China, 410011
Actively Recruiting
39
West China Hospital, Sichuan University
Cheng Du Shi, China, 610041
Actively Recruiting
40
The Fourth People's Hospital of Chengdu
Chengdu, China, 610036
Actively Recruiting
41
Guangzhou Brain Hospital
Guangzhou, China, 510370
Actively Recruiting
42
The Seventh People's Hospital of Hangzhou
Hangzhou, China, 310000
Actively Recruiting
43
Zhejiang Provincial People's Hospital
Hangzhou, China, 310014
Actively Recruiting
44
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, China, 310016
Actively Recruiting
45
The Fourth Hospital of Harbin Medical University
Harbin, China, 150001
Actively Recruiting
46
Hefei No.4 People's Hospital
Hefei, China, 230061
Actively Recruiting
47
Huzhou Third Municipal Hospital
Huzhou, China, 313000
Actively Recruiting
48
Shandong Mental Health Center
Jinan, China, 250012
Actively Recruiting
49
First Affiliated Hospital of Kunming Medical University
Kunming, China, 650032
Actively Recruiting
50
The Affilicated Kangning Hospital of Ningbo University
Ningbo, China, 315201
Actively Recruiting
51
Shanghai Mental Health Center
Shanghai, China, 200030
Actively Recruiting
52
Shenzhen Kangning Hospital
Shenzhen, China, 518003
Actively Recruiting
53
The First Hospital of Hebei Medical University
Shijiazhuang, China, 050031
Actively Recruiting
54
The Affiliated hospital of Southwest Medical University
Sichuan, China, 646000
Actively Recruiting
55
Wuhu Hospital of Beijing Anding hospital
Wuhu, China, 242407
Actively Recruiting
56
Xi An Mental Health Center
Xi'an, China, 710061
Actively Recruiting
57
Xiamen Xianyue Hospital
Xiamen, China, 361012
Actively Recruiting
58
Xianyang Hospital of Yan'an University
Xianyang, China, 712000
Actively Recruiting
59
Psychiatric Hospital of Henan Province
Xinxiang, China, 453003
Actively Recruiting
60
Zhenjiang Mental Health Center
Zhenjiang, China, 212000
Actively Recruiting
61
Zhumadian Psychiatric Hospital
Zhumadian, China, 463000
Actively Recruiting
62
FutureMeds GmbH
Berlin, Germany, 10629
Actively Recruiting
63
Velocity Clinical Research, Berlin
Berlin, Germany, 10787
Actively Recruiting
64
Klinische Forschung Dresden
Dresden, Germany, 01069
Actively Recruiting
65
Klinische Forschung Hamburg
Hamburg, Germany, 20253
Actively Recruiting
66
Zentralinstitut für Seelische Gesundheit
Mannheim, Germany, 68159
Actively Recruiting
67
Dedicated Research Site FutureMeds
Offenbach, Germany, 63065
Actively Recruiting
68
Klinische forschung Schwerin GmbH
Schwerin, Germany, 19055
Actively Recruiting
69
Takahashi Psychiatric Clinic
Ashiya, Japan, 659-0093
Not Yet Recruiting
70
Tokyo-Eki Center-building Clinic
Chūōku, Japan, 103-0027
Actively Recruiting
71
Ai Sakura Clinic
Fukuoka, Japan, 810-0001
Actively Recruiting
72
Hiro Mental Clinic
Fukuoka, Japan, 810-0004
Actively Recruiting
73
Rainbow and Sea Hospital
Karatsu, Japan, 847-0031
Actively Recruiting
74
Tatsuta Clinic
Kobe, Japan, 651-0097
Actively Recruiting
75
Arata Clinic
Nagasaki, Japan, 852-8137
Actively Recruiting
76
Yokogawa Ekimae Clinic
Nishi, Japan, 733-0011
Actively Recruiting
77
Teine Keijinkai Hospital
Sapporo, Japan, 006-0811
Not Yet Recruiting
78
Hillside Clinic Jingumae
Shibuya City, Japan, 150-0001
Actively Recruiting
79
Samoncho Clinic
Shinjuku, Japan, 160-0017
Actively Recruiting
80
Keiai Clinic
Shinjuku-ku, Japan, 160-0004
Actively Recruiting
81
Higashi Shinjuku Clinic
Shinjuku-ku, Japan, 169-0072
Actively Recruiting
82
Sakurazaka Clinic SophyAnce
Tokyo, Japan, 106-0032
Actively Recruiting
83
Noguchi Naika Clinic
Tokyo, Japan, 165-0031
Actively Recruiting
84
Tsukuba University Hospital
Tsukuba, Japan, 305-8576
Actively Recruiting
85
Maekawa Medical Clinic
Yokohama, Japan, 220-0004
Actively Recruiting
86
Makoto Kokoro No Clinic
Yokohama, Japan, 231-0032
Not Yet Recruiting
87
National Hospital Organization Hizen Psychiatric Medical Center
Yoshinogari-cho, Kanzaki-gun, Japan, 842-0192
Actively Recruiting
88
Hallym University Sacred Heart Hospital
Anyang-si, South Korea, 14068
Not Yet Recruiting
89
Pusan National University Yangsan Hospital
Busan, South Korea, 50612
Not Yet Recruiting
90
Chungbuk National University Hospital
Cheongju-si, South Korea, 28644
Not Yet Recruiting
91
Hanyang University Guri Hospital
Guri-si, South Korea, 11923
Not Yet Recruiting
92
Inha University Hospital
Incheon, South Korea, 22332
Not Yet Recruiting
93
Kyungpook National University Hospital
Junggu, South Korea, 41944
Not Yet Recruiting
94
Gachon University Gil Medical Center
Namdong-gu, South Korea, 21565
Not Yet Recruiting
95
Konyang University Hospital
Seogu, South Korea, 35365
Not Yet Recruiting
96
Konyang University Hospital
Seogu, South Korea, 35365
Not Yet Recruiting
97
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Not Yet Recruiting
98
Seoul National University Hospital
Seoul, South Korea, 03080
Not Yet Recruiting
99
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Not Yet Recruiting
100
Hanyang University Seoul Hospital
Seoul, South Korea, 04763
Not Yet Recruiting
101
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Not Yet Recruiting
102
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea, 11765
Not Yet Recruiting
103
Changhua Christian Hospital
Changhua County, Taiwan, 50006
Not Yet Recruiting
104
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, Taiwan, 970
Not Yet Recruiting
105
China Medical University Hospital
Taichung, Taiwan, 404332
Actively Recruiting
106
Mackay Memorial Hospital
Taipei, Taiwan, 10449
Actively Recruiting
107
Tri-Service General Hospital
Taipei, Taiwan, 114
Not Yet Recruiting
108
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Not Yet Recruiting
109
Layton Medical Centre
Blackpool, United Kingdom, FY3 7EN
Actively Recruiting
110
Clerkenwell Health - Doncaster
Doncaster, United Kingdom, DN4 8QN
Not Yet Recruiting
111
St Pancras Clinical Research - Eastbourne
Eastbourne, United Kingdom, BN23 5UZ
Not Yet Recruiting
112
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
113
Mounts Bay Medical Hub
Hayle, United Kingdom, TR27 5DT
Actively Recruiting
114
HMC Health Group - Meadows Centre for Health
Hounslow, United Kingdom, TW4 7NR
Actively Recruiting
115
St Pancras Clinical Research
London, United Kingdom, EC2Y 8EA
Not Yet Recruiting
116
Clerkenwell Health - London - Baker Street
London, United Kingdom, W1U 6RP
Actively Recruiting
117
Newquay Health Centre
Newquay, United Kingdom, TR7 1RU
Actively Recruiting
118
Panthera Biopartners - Preston
Preston, United Kingdom, PR2 9QB
Actively Recruiting
119
Wickersley Health Centre - Clifton Medical Centre
Rotherham, United Kingdom, S65 1DA
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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