Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07219953

A Study of Brenipatide in Participants With Alcohol Use Disorder

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

1100

Participants Needed

114

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 Alcohol Use Disorder (AUD) and hazardous alcohol use. Participation in this study will last approximately 56 weeks.

CONDITIONS

Official Title

A Study of Brenipatide in Participants With 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 cut down on drinking
  • Willing and able to attend all study visits and follow study procedures, including self-injecting the study drug or receiving assistance from a trained support person
  • Able to store and use the blinded study intervention as directed
  • Willing to maintain electronic and paper study diaries and 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
  • Recent 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 confirmed by prior tests or imaging
  • Participation in another clinical study with active treatment in the past 90 days or 5 half-lives of the treatment (whichever is longer) 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: 114 locations

1

Headlands Research - Scottsdale

Scottsdale, Arizona, United States, 85260

Actively Recruiting

2

Woodland International Research Group

Little Rock, Arkansas, United States, 72211

Not Yet 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

Not Yet Recruiting

19

Adams Clinical Boston

Boston, Massachusetts, United States, 02116

Actively Recruiting

20

Adams Clinical Bronx

The Bronx, New York, United States, 10461

Actively Recruiting

21

North Star Medical Research

Middleburg Heights, Ohio, United States, 44130

Actively Recruiting

22

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

23

K2 Medical Research - East Providence

East Providence, Rhode Island, United States, 02914

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

Tokyo-Eki Center-building Clinic

Chūōku, Japan, 103-0027

Actively Recruiting

70

Ai Sakura Clinic

Fukuoka, Japan, 810-0001

Actively Recruiting

71

Hiro Mental Clinic

Fukuoka, Japan, 810-0004

Actively Recruiting

72

Rainbow and Sea Hospital

Karatsu, Japan, 847-0031

Actively Recruiting

73

Tatsuta Clinic

Kobe, Japan, 651-0097

Actively Recruiting

74

Arata Clinic

Nagasaki, Japan, 852-8137

Actively Recruiting

75

Yokogawa Ekimae Clinic

Nishi, Japan, 733-0011

Actively Recruiting

76

Teine Keijinkai Hospital

Sapporo, Japan, 006-0811

Not Yet Recruiting

77

Hillside Clinic Jingumae

Shibuya City, Japan, 150-0001

Actively Recruiting

78

Samoncho Clinic

Shinjuku, Japan, 160-0017

Actively Recruiting

79

Keiai Clinic

Shinjuku-ku, Japan, 160-0004

Actively Recruiting

80

Higashi Shinjuku Clinic

Shinjuku-ku, Japan, 169-0072

Actively Recruiting

81

Sakurazaka Clinic SophyAnce

Tokyo, Japan, 106-0032

Actively Recruiting

82

Noguchi Naika Clinic

Tokyo, Japan, 165-0031

Actively Recruiting

83

Tsukuba University Hospital

Tsukuba, Japan, 305-8576

Actively Recruiting

84

Maekawa Medical Clinic

Yokohama, Japan, 220-0004

Actively Recruiting

85

National Hospital Organization Hizen Psychiatric Medical Center

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

Actively Recruiting

86

Hallym University Sacred Heart Hospital

Anyang-si, South Korea, 14068

Not Yet Recruiting

87

Pusan National University Yangsan Hospital

Busan, South Korea, 50612

Not Yet Recruiting

88

Chungbuk National University Hospital

Cheongju-si, South Korea, 28644

Not Yet Recruiting

89

Hanyang University Guri Hospital

Guri-si, South Korea, 11923

Not Yet Recruiting

90

Inha University Hospital

Incheon, South Korea, 22332

Not Yet Recruiting

91

Kyungpook National University Hospital

Junggu, South Korea, 41944

Not Yet Recruiting

92

Gachon University Gil Medical Center

Namdong-gu, South Korea, 21565

Not Yet Recruiting

93

Konyang University Hospital

Seogu, South Korea, 35365

Not Yet Recruiting

94

Konyang University Hospital

Seogu, South Korea, 35365

Not Yet Recruiting

95

Seoul National University Bundang Hospital

Seongnam, South Korea, 13620

Not Yet Recruiting

96

Seoul National University Hospital

Seoul, South Korea, 03080

Not Yet Recruiting

97

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Not Yet Recruiting

98

Hanyang University Seoul Hospital

Seoul, South Korea, 04763

Not Yet Recruiting

99

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

Seoul, South Korea, 06591

Not Yet Recruiting

100

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

Uijeongbu-si, South Korea, 11765

Not Yet Recruiting

101

Changhua Christian Hospital

Changhua County, Taiwan, 50006

Not Yet Recruiting

102

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Taiwan, 970

Not Yet Recruiting

103

China Medical University Hospital

Taichung, Taiwan, 404332

Actively Recruiting

104

Mackay Memorial Hospital

Taipei, Taiwan, 10449

Not Yet Recruiting

105

Tri-Service General Hospital

Taipei, Taiwan, 114

Not Yet Recruiting

106

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan, 333

Not Yet Recruiting

107

Layton Medical Centre

Blackpool, United Kingdom, FY3 7EN

Actively Recruiting

108

Queen Elizabeth University Hospital

Glasgow, United Kingdom, G51 4TF

Actively Recruiting

109

Mounts Bay Medical Hub

Hayle, United Kingdom, TR27 5DT

Actively Recruiting

110

HMC Health Group - Meadows Centre for Health

Hounslow, United Kingdom, TW4 7NR

Actively Recruiting

111

Clerkenwell Health - London - Baker Street

London, United Kingdom, W1U 6RP

Actively Recruiting

112

Newquay Health Centre

Newquay, United Kingdom, TR7 1RU

Actively Recruiting

113

Panthera Biopartners - Preston

Preston, United Kingdom, PR2 9QB

Actively Recruiting

114

Wickersley Health Centre - Clifton Medical Centre

Rotherham, United Kingdom, S65 1DA

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 Alcohol Use Disorder | DecenTrialz