Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07219966

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

Led by Eli Lilly and Company · Updated on 2026-05-14

1100

Participants Needed

119

Research Sites

128 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant must be a minimum of 20 years of age for the investigative sites in Japan.
  • Seeking treatment and motivated to stop or reduce drinking.
  • Willing and able to attend all study visits and follow study procedures.
  • Able to self-inject the study medication.
  • Able to store and use the blinded study medication as directed.
  • Willing to maintain electronic and paper diaries.
  • Able to complete required questionnaires.
Not Eligible

You will not qualify if you...

  • Current or recent (within 180 days) substance use disorder other than alcohol, nicotine, or caffeine.
  • Suicidal thoughts or behaviors 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 medical history 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

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Trial Site Locations

Total: 119 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

Not Yet 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

Not Yet Recruiting

19

Adams Clinical Boston

Boston, Massachusetts, United States, 02116

Actively Recruiting

20

K2 Medical Research - East Providence

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

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

Kuramitsu Hospital

Fukuoka, Japan, 819-0037

Actively Recruiting

74

Rainbow and Sea Hospital

Karatsu, Japan, 847-0031

Actively Recruiting

75

Kariya Hospital

Kariya, Japan, 448-0851

Actively Recruiting

76

Tatsuta Clinic

Kobe, Japan, 651-0097

Actively Recruiting

77

Arata Clinic

Nagasaki, Japan, 852-8137

Actively Recruiting

78

Yokogawa Ekimae Clinic

Nishi, Japan, 733-0011

Actively Recruiting

79

Teine Keijinkai Hospital

Sapporo, Japan, 006-0811

Not Yet Recruiting

80

Sangenjaya Shinkeika Shinryonaika Clinic

Setagaya City, Japan, 154-0004

Actively Recruiting

81

Hillside Clinic Jingumae

Shibuya City, Japan, 150-0001

Actively Recruiting

82

Kaedenomori Mental Clinic

Shibuya City, Japan, 150-0022

Actively Recruiting

83

Samoncho Clinic

Shinjuku, Japan, 160-0017

Actively Recruiting

84

Keiai Clinic

Shinjuku-ku, Japan, 160-0004

Actively Recruiting

85

Higashi Shinjuku Clinic

Shinjuku-ku, Japan, 169-0072

Actively Recruiting

86

Sakurazaka Clinic SophyAnce

Tokyo, Japan, 106-0032

Actively Recruiting

87

Noguchi Naika Clinic

Tokyo, Japan, 165-0031

Actively Recruiting

88

Tsukuba University Hospital

Tsukuba, Japan, 305-8576

Actively Recruiting

89

Maekawa Medical Clinic

Yokohama, Japan, 220-0004

Actively Recruiting

90

National Hospital Organization Hizen Psychiatric Medical Center

Yoshinogari-cho, Kanzaki-gun, Japan, 842-0192

Actively Recruiting

91

Hallym University Sacred Heart Hospital

Anyang-si, South Korea, 14068

Not Yet Recruiting

92

Pusan National University Yangsan Hospital

Busan, South Korea, 50612

Not Yet Recruiting

93

Chungbuk National University Hospital

Cheongju-si, South Korea, 28644

Not Yet Recruiting

94

Hanyang University Guri Hospital

Guri-si, South Korea, 11923

Actively Recruiting

95

Inha University Hospital

Incheon, South Korea, 22332

Not Yet Recruiting

96

Kyungpook National University Hospital

Junggu, South Korea, 41944

Not Yet Recruiting

97

Gachon University Gil Medical Center

Namdong-gu, South Korea, 21565

Actively Recruiting

98

Konyang University Hospital

Seogu, South Korea, 35365

Actively Recruiting

99

Konyang University Hospital

Seogu, South Korea, 35365

Actively Recruiting

100

Seoul National University Bundang Hospital

Seongnam, South Korea, 13620

Not Yet Recruiting

101

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

102

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

103

Hanyang University Seoul Hospital

Seoul, South Korea, 04763

Not Yet Recruiting

104

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, South Korea, 06591

Not Yet Recruiting

105

The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea, 11765

Not Yet Recruiting

106

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Taiwan, 970

Not Yet Recruiting

107

China Medical University Hospital

Taichung, Taiwan, 404332

Actively Recruiting

108

Mackay Memorial Hospital

Taipei, Taiwan, 10449

Not Yet Recruiting

109

Taipei City Hospital - Songde Branch

Taipei, Taiwan, 110204

Not Yet Recruiting

110

Tri-Service General Hospital

Taipei, Taiwan, 114

Not Yet Recruiting

111

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan, 333

Actively Recruiting

112

Layton Medical Centre

Blackpool, United Kingdom, FY3 7EN

Not Yet Recruiting

113

Edinburgh Royal Infirmary

Edinburgh, United Kingdom, EH16 4SA

Not Yet Recruiting

114

Queen Elizabeth University Hospital

Glasgow, United Kingdom, G51 4TF

Actively Recruiting

115

St Pancras Clinical Research

London, United Kingdom, EC2Y 8EA

Actively Recruiting

116

National Institute for Health Research (NIHR) - King's Clinical Research Facility (CRF)

London, United Kingdom, SE5 9RS

Not Yet Recruiting

117

Clerkenwell Health - London - Baker Street

London, United Kingdom, W1U 6RP

Actively Recruiting

118

Salford Royal Hospital

Salford, United Kingdom, M6 8HD

Not Yet Recruiting

119

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Actively Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

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