Actively Recruiting
A Phase 3, Randomized, Double-Blind Study Comparing Brenipatide With Placebo for Adults With Moderate-to-Severe Alcohol Use Disorder
Led by Eli Lilly and Company · Updated on 2026-06-03
1100
Participants Needed
123
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating brenipatide, compared to a placebo, in adults with moderate-to-severe Alcohol Use Disorder (AUD). This study aims to assess how brenipatide affects drinking patterns and its safety over a period of approximately 56 weeks. The trial is a phase 3, multicenter, randomized, double-blind study sponsored by Eli Lilly and Company. Participants will receive escalating doses of brenipatide or placebo, administered by subcutaneous injection. The study includes multiple experimental periods where participants receive the study drug or placebo under controlled conditions. The dosing is carefully monitored to assess the drug's effects compared to placebo. During the study, participants will undergo regular assessments including drinking behavior tracked by the Timeline Followback Method, craving levels measured by the Penn Alcohol Craving Scale, and health outcomes collected through questionnaires. Safety will be monitored by evaluating laboratory tests and adverse events. The total participation lasts up to 56 weeks with ongoing monitoring throughout this period.
CONDITIONS
Brief Title
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be at least 20 years old at investigative sites in Japan
- Seeking treatment and motivated to stop or cut down on drinking
- Willing and able to make themselves available for the study duration and attend required visits
- Able and willing to self-inject the study intervention
- Able and willing to store and use the blinded study intervention as directed
- Willing to maintain electronic and paper study diaries as applicable
- Able to complete required questionnaires
You will not qualify if you...
- Evidence of substance use disorder involving illicit or nonprescribed drugs within 180 days prior to screening, except alcohol, nicotine, or caffeine
- Suicidal ideation or behavior within the past 6 months as indicated by the Columbia-Suicide Severity Rating Scale
- History of advanced liver disease or alcohol-associated hepatitis based on histology or imaging
- Participation in another clinical study 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.
Duration - Up to 56 weeks
Participants receive escalating doses of the study drug or placebo administered by subcutaneous injection.
Regular visits for dosing and assessments throughout treatment
Trial Site Locations
Total: 123 locations
1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
Actively Recruiting
2
Headlands Research - Scottsdale
Scottsdale, Arizona, United States, 85260
Actively Recruiting
3
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Actively Recruiting
4
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California, United States, 90095
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
Mountain Mind - Denver
Denver, Colorado, United States, 80202
Actively Recruiting
8
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, United States, 33803
Actively 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
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
25
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
26
Adams Clinical Dallas
DeSoto, Texas, United States, 75115
Actively Recruiting
27
Pillar Clinical Research - Richardson
Richardson, Texas, United States, 75080
Actively Recruiting
28
Alpine Research Organization
Clinton, Utah, United States, 84015
Actively Recruiting
29
Re:Cognition Health
Fairfax, Virginia, United States, 22031
Actively Recruiting
30
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Actively Recruiting
31
ANIMA Research
Diepenbeek, Belgium, 3590
Actively Recruiting
32
Kormont
Kluisbergen, Belgium, 9690
Actively Recruiting
33
Gezondheidshuis De Gloed
Machelen, Belgium, 9870
Actively Recruiting
34
Meclinas
Mechelen, Belgium, 2800
Actively Recruiting
35
Medisch Centrum Saffrou
Oudenaarde, Belgium, 9636
Actively Recruiting
36
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, China, 100088
Actively Recruiting
37
Beijing HuiLongGuan Hospital
Beijing, China, 100096
Actively Recruiting
38
The Second People's Hospital of Hunan Province
Changsha, China, 410007
Actively Recruiting
39
The Second Xiangya Hospital of Central South University
Changsha, China, 410011
Actively Recruiting
40
West China Hospital, Sichuan University
Cheng Du Shi, China, 610041
Actively Recruiting
41
The Fourth People's Hospital of Chengdu
Chengdu, China, 610036
Actively Recruiting
42
Guangzhou Brain Hospital
Guangzhou, China, 510370
Actively Recruiting
43
The Seventh People's Hospital of Hangzhou
Hangzhou, China, 310000
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
Huzhou Third Municipal Hospital
Huzhou, China, 313000
Actively Recruiting
47
Shandong Mental Health Center
Jinan, China, 250012
Actively Recruiting
48
First Affiliated Hospital of Kunming Medical University
Kunming, China, 650032
Actively Recruiting
49
The Third Hospital of Mianyang
Mianyang, China, 621000
Actively Recruiting
50
The First Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Actively Recruiting
51
The Affilicated Kangning Hospital of Ningbo University
Ningbo, China, 315201
Actively Recruiting
52
Shanghai Mental Health Center
Shanghai, China, 200030
Actively Recruiting
53
Shenzhen Kangning Hospital
Shenzhen, China, 518003
Actively Recruiting
54
The First Hospital of Hebei Medical University
Shijiazhuang, China, 050031
Actively Recruiting
55
The Affiliated hospital of Southwest Medical University
Sichuan, China, 646000
Actively Recruiting
56
Tianjin Anding Hospital
Tianjin, China, 300022
Actively Recruiting
57
Wuhu Hospital of Beijing Anding hospital
Wuhu, China, 242407
Actively Recruiting
58
Xi An Mental Health Center
Xi'an, China, 710061
Actively Recruiting
59
Xiamen Xianyue Hospital
Xiamen, China, 361012
Actively Recruiting
60
Xianyang Hospital of Yan'an University
Xianyang, China, 712000
Actively Recruiting
61
Psychiatric Hospital of Henan Province
Xinxiang, China, 453003
Actively Recruiting
62
Zhenjiang Mental Health Center
Zhenjiang, China, 212000
Actively Recruiting
63
FutureMeds GmbH
Berlin, Germany, 10629
Actively Recruiting
64
Velocity Clinical Research, Berlin
Berlin, Germany, 10787
Actively Recruiting
65
Klinische Forschung Dresden
Dresden, Germany, 01069
Actively Recruiting
66
Klinische Forschung Hamburg
Hamburg, Germany, 20253
Actively Recruiting
67
Zentralinstitut für Seelische Gesundheit
Mannheim, Germany, 68159
Actively Recruiting
68
Dedicated Research Site FutureMeds
Offenbach, Germany, 63065
Actively Recruiting
69
Klinische forschung Schwerin GmbH
Schwerin, Germany, 19055
Actively Recruiting
70
Takahashi Psychiatric Clinic
Ashiya, Japan, 659-0093
Not Yet Recruiting
71
Tokyo-Eki Center-building Clinic
Chūōku, Japan, 103-0027
Actively Recruiting
72
Ai Sakura Clinic
Fukuoka, Japan, 810-0001
Actively Recruiting
73
Hiro Mental Clinic
Fukuoka, Japan, 810-0004
Actively Recruiting
74
Kuramitsu Hospital
Fukuoka, Japan, 819-0037
Actively Recruiting
75
Rainbow and Sea Hospital
Karatsu, Japan, 847-0031
Actively Recruiting
76
Kariya Hospital
Kariya, Japan, 448-0851
Actively Recruiting
77
Tatsuta Clinic
Kobe, Japan, 651-0097
Actively Recruiting
78
Arata Clinic
Nagasaki, Japan, 852-8137
Actively Recruiting
79
Yokogawa Ekimae Clinic
Nishi, Japan, 733-0011
Actively Recruiting
80
Teine Keijinkai Hospital
Sapporo, Japan, 006-0811
Not Yet Recruiting
81
Sangenjaya Shinkeika Shinryonaika Clinic
Setagaya City, Japan, 154-0004
Actively Recruiting
82
Hillside Clinic Jingumae
Shibuya City, Japan, 150-0001
Actively Recruiting
83
Kaedenomori Mental Clinic
Shibuya City, Japan, 150-0022
Actively Recruiting
84
Samoncho Clinic
Shinjuku, Japan, 160-0017
Actively Recruiting
85
Keiai Clinic
Shinjuku-ku, Japan, 160-0004
Actively Recruiting
86
Higashi Shinjuku Clinic
Shinjuku-ku, Japan, 169-0072
Actively Recruiting
87
Sakurazaka Clinic SophyAnce
Tokyo, Japan, 106-0032
Actively Recruiting
88
Noguchi Naika Clinic
Tokyo, Japan, 165-0031
Actively Recruiting
89
Tsukuba University Hospital
Tsukuba, Japan, 305-8576
Actively Recruiting
90
Maekawa Medical Clinic
Yokohama, Japan, 220-0004
Actively Recruiting
91
Makoto Kokoro No Clinic
Yokohama, Japan, 231-0032
Not Yet Recruiting
92
National Hospital Organization Hizen Psychiatric Medical Center
Yoshinogari-cho, Kanzaki-gun, Japan, 842-0192
Actively Recruiting
93
Hallym University Sacred Heart Hospital
Anyang-si, South Korea, 14068
Not Yet Recruiting
94
Pusan National University Yangsan Hospital
Busan, South Korea, 50612
Actively Recruiting
95
Chungbuk National University Hospital
Cheongju-si, South Korea, 28644
Actively Recruiting
96
Hanyang University Guri Hospital
Guri-si, South Korea, 11923
Actively Recruiting
97
Inha University Hospital
Incheon, South Korea, 22332
Not Yet Recruiting
98
Kyungpook National University Hospital
Junggu, South Korea, 41944
Actively Recruiting
99
Gachon University Gil Medical Center
Namdong-gu, South Korea, 21565
Actively Recruiting
100
Konyang University Hospital
Seogu, South Korea, 35365
Actively Recruiting
101
Konyang University Hospital
Seogu, South Korea, 35365
Actively Recruiting
102
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
103
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
104
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
105
Hanyang University Seoul Hospital
Seoul, South Korea, 04763
Actively Recruiting
106
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
107
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea, 11765
Not Yet Recruiting
108
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, Taiwan, 970
Actively Recruiting
109
China Medical University Hospital
Taichung, Taiwan, 404332
Actively Recruiting
110
Mackay Memorial Hospital
Taipei, Taiwan, 10449
Actively Recruiting
111
Taipei City Hospital - Songde Branch
Taipei, Taiwan, 110204
Actively Recruiting
112
Tri-Service General Hospital
Taipei, Taiwan, 114
Actively Recruiting
113
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Actively Recruiting
114
Layton Medical Centre
Blackpool, United Kingdom, FY3 7EN
Actively Recruiting
115
St Pancras Clinical Research - Chester
Chester, United Kingdom, CH2 1HX
Not Yet Recruiting
116
St Pancras Clinical Research - Eastbourne
Eastbourne, United Kingdom, BN23 5UZ
Not Yet Recruiting
117
Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA
Actively Recruiting
118
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
119
St Pancras Clinical Research
London, United Kingdom, EC2Y 8EA
Actively Recruiting
120
National Institute for Health Research (NIHR) - King's Clinical Research Facility (CRF)
London, United Kingdom, SE5 9RS
Not Yet Recruiting
121
Clerkenwell Health - London - Baker Street
London, United Kingdom, W1U 6RP
Actively Recruiting
122
Greater Manchester Mental Health NHS Foundation Trust
Manchester, United Kingdom, M25 3BL
Not Yet Recruiting
123
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
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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