- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07219953
- Original Trial
A Study of Brenipatide in Participants With Alcohol Use Disorder (RENEW-ALC-2)
A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Alcohol Use Disorder (RENEW-ALC-2)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 1-317-615-4559
- Email: LillyTrials@Lilly.com
Study Contact Backup
- Name: Physicians interested in becoming principal investigators please contact
- Email: clinical_inquiry_hub@lilly.com
Study Locations
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Diepenbeek, Belgium, 3590
- Recruiting
- ANIMA Research
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Principal Investigator:
- Erik Buntinx
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Contact:
- Phone Number: 003211316272
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Kluisbergen, Belgium, 9690
- Recruiting
- Kormont
-
Principal Investigator:
- Klaas Vercruysse
-
Contact:
- Phone Number: 32 496 376259
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Machelen, Belgium, 9870
- Recruiting
- Gezondheidshuis De Gloed
-
Principal Investigator:
- Klaas Vercruysse
-
Contact:
- Phone Number: 32 496 376259
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Mechelen, Belgium, 2800
- Recruiting
- Meclinas
-
Principal Investigator:
- Claudia Cornelis
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Contact:
- Phone Number: 003215792797
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Oudenaarde, Belgium, 9636
- Recruiting
- Medisch Centrum Saffrou
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Principal Investigator:
- Klaas Vercruysse
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Contact:
- Phone Number: 32 496 376259
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Beijing, China, 100096
- Recruiting
- Beijing HuiLongGuan Hospital
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Principal Investigator:
- Yunlong Tan
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Beijing, China, 100088
- Active, not recruiting
- Beijing Anding Hospital - Affiliated Capital University of Medical Science
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Changsha, China, 410011
- Active, not recruiting
- The Second Xiangya Hospital of Central South University
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Changsha, China, 410007
- Active, not recruiting
- The Second People's Hospital of Hunan Province
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Cheng Du Shi, China, 610041
- Active, not recruiting
- West China Hospital, Sichuan University
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Chengdu, China, 610036
- Active, not recruiting
- The Fourth People's Hospital of Chengdu
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Guangzhou, China, 510370
- Active, not recruiting
- Guangzhou Brain Hospital
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Hangzhou, China, 310014
- Active, not recruiting
- Zhejiang Provincial People's Hospital
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Hangzhou, China, 310000
- Active, not recruiting
- The Seventh People's Hospital of Hangzhou
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Hangzhou, China, 310016
- Active, not recruiting
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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Harbin, China, 150001
- Active, not recruiting
- The Fourth Hospital of Harbin Medical University
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Hefei, China, 230061
- Active, not recruiting
- Hefei No.4 People's Hospital
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Huzhou, China, 313000
- Completed
- Huzhou Third Municipal Hospital
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Jinan, China, 250012
- Active, not recruiting
- Shandong Mental Health Center
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Kunming, China, 650032
- Active, not recruiting
- First Affiliated Hospital of Kunming Medical University
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Ningbo, China, 315201
- Active, not recruiting
- The Affilicated Kangning Hospital of Ningbo University
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Shanghai, China, 200030
- Active, not recruiting
- Shanghai Mental Health Center
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Shenzhen, China, 518003
- Active, not recruiting
- Shenzhen Kangning Hospital
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Shijiazhuang, China, 050031
- Active, not recruiting
- The First Hospital of Hebei Medical University
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Sichuan, China, 646000
- Active, not recruiting
- The Affiliated hospital of Southwest Medical University
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Wuhu, China, 242407
- Active, not recruiting
- Wuhu Hospital of Beijing Anding hospital
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Xi'an, China, 710061
- Recruiting
- Xi An Mental Health Center
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Principal Investigator:
- Guibin Li
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Xiamen, China, 361012
- Active, not recruiting
- Xiamen Xianyue Hospital
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Xianyang, China, 712000
- Active, not recruiting
- Xianyang Hospital of Yan'an University
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Xinxiang, China, 453003
- Active, not recruiting
- Psychiatric Hospital of Henan Province
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Zhenjiang, China, 212000
- Active, not recruiting
- Zhenjiang Mental Health Center
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Zhumadian, China, 463000
- Active, not recruiting
- Zhumadian Psychiatric Hospital
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Berlin, Germany, 10787
- Active, not recruiting
- Velocity Clinical Research, Berlin
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Berlin, Germany, 10629
- Active, not recruiting
- FutureMeds Berlin
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Dresden, Germany, 01069
- Active, not recruiting
- Klinische Forschung Dresden
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Hamburg, Germany, 20253
- Active, not recruiting
- Klinische Forschung Hamburg
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Mannheim, Germany, 68159
- Active, not recruiting
- Zentralinstitut für Seelische Gesundheit
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Offenbach, Germany, 63065
- Active, not recruiting
- FutureMeds Offenbach
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Schwerin, Germany, 19055
- Active, not recruiting
- Klinische forschung Schwerin GmbH
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Chūōku, Japan, 103-0027
- Recruiting
- Tokyo-Eki Center-building Clinic
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Arihiro Kiyosue
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Fukuoka, Japan, 810-0001
- Recruiting
- Ai Sakura Clinic
-
Contact:
- Phone Number: 81120023812
-
Principal Investigator:
- Masamiki Kimura
-
Fukuoka, Japan, 810-0004
- Recruiting
- Hiro Mental Clinic
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Hiroaki Furui
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Karatsu, Japan, 847-0031
- Recruiting
- Rainbow and Sea Hospital
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Taro Shindo
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Kobe, Japan, 651-0097
- Recruiting
- Tatsuta Clinic
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Kenji Tatsuta
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Nagasaki, Japan, 852-8137
- Recruiting
- Arata Clinic
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Contact:
- Phone Number: 81120023812
-
Principal Investigator:
- Takatoshi Mori
-
Nakano, Japan, 165-0031
- Recruiting
- Noguchi Naika Clinic
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Yoshimasa Noguchi
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Nishi, Japan, 733-0011
- Recruiting
- Yokogawa Ekimae Clinic
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Contact:
- Phone Number: 81120023812
-
Principal Investigator:
- Ariyuki Kagaya
-
Shibuya City, Japan, 150-0001
- Recruiting
- Hillside Clinic Jingumae
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Contact:
- Phone Number: 81120023812
-
Principal Investigator:
- Masayoshi SONE
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Shinjuku, Japan, 160-0017
- Recruiting
- Samoncho Clinic
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Takahiro Yokoyama
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Shinjuku-ku, Japan, 169-0072
- Recruiting
- Higashi Shinjuku Clinic
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Hiroaki Kondo
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Shinjuku-ku, Japan, 160-0004
- Recruiting
- Keiai Clinic
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Yoshinori Horie
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Tokyo, Japan, 106-0032
- Recruiting
- Sakurazaka Clinic SophyAnce
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Haruhito Muto
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Tsukuba, Japan, 305-8576
- Recruiting
- Tsukuba University Hospital
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Hisashi Yoshimoto
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Yokohama, Japan, 220-0004
- Recruiting
- Maekawa Medical Clinic
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Hiromitsu Maekawa
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Yoshinogari-cho, Kanzaki-gun, Japan, 842-0192
- Recruiting
- National Hospital Organization Hizen Psychiatric Medical Center
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Contact:
- Phone Number: 81120023812
-
Principal Investigator:
- Kazunori Matsuguchi
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-
-
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Anyang-si, South Korea, 14068
- Recruiting
- Hallym University Sacred Heart Hospital
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Principal Investigator:
- Kyung Hee Park
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Busan, South Korea, 50612
- Recruiting
- Pusan National University Yangsan Hospital
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Principal Investigator:
- Sang Yeoup Lee
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Contact:
- Phone Number: 82-55-360-2860
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Cheongju-si, South Korea, 28644
- Recruiting
- Chungbuk National University Hospital
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Principal Investigator:
- Joon Hyung Jung
-
Guri-si, South Korea, 11923
- Recruiting
- Hanyang University Guri Hospital
-
Principal Investigator:
- Sangmo Hong
-
Incheon, South Korea, 22332
- Recruiting
- Inha University Hospital
-
Principal Investigator:
- Yangsik Kim
-
Junggu, South Korea, 41944
- Recruiting
- Kyungpook National University Hospital
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Principal Investigator:
- Hae-Jin Ko
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Namdong-gu, South Korea, 21565
- Recruiting
- Gachon University Gil Medical Center
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Principal Investigator:
- Kyoung-Kon Kim
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Contact:
- Phone Number: +82-32-458-2778
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Seogu, South Korea, 35365
- Recruiting
- Konyang University Hospital
-
Principal Investigator:
- Jee Hyun Kang
-
Principal Investigator:
- Hong Seok Oh
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Seongnam, South Korea, 13620
- Recruiting
- Seoul National University Bundang Hospital
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Principal Investigator:
- Kiheon Lee
-
Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital
-
Principal Investigator:
- BeLong Cho
-
Seoul, South Korea, 03722
- Recruiting
- Severance Hospital, Yonsei University Health System
-
Principal Investigator:
- Byung Wan Lee
-
Seoul, South Korea, 06591
- Recruiting
- The Catholic Univ. of Korea Seoul St. Mary's Hospital
-
Principal Investigator:
- Daijin Kim
-
Seoul, South Korea, 04763
- Recruiting
- Hanyang University Seoul Hospital
-
Principal Investigator:
- Sungwon Roh
-
Uijeongbu-si, South Korea, 11765
- Recruiting
- The Catholic University of Korea, Uijeongbu St. Mary's Hospital
-
Principal Investigator:
- Hae Kook Lee
-
-
-
-
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Changhua County, Taiwan, 50006
- Recruiting
- Changhua Christian Hospital
-
Principal Investigator:
- Hsu Wen-Yu
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Hualien City, Taiwan, 970
- Recruiting
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
-
Principal Investigator:
- Shao-Tsu Chen
-
Taichung, Taiwan, 404332
- Recruiting
- China Medical University Hospital
-
Principal Investigator:
- Wan-Ju Cheng
-
Taipei, Taiwan, 114
- Recruiting
- Tri-Service General Hospital
-
Principal Investigator:
- San-Yuan Huang
-
Taipei, Taiwan, 10449
- Recruiting
- Mackay Memorial Hospital
-
Principal Investigator:
- Chen-Ju Lin
-
Taoyuan, Taiwan, 333
- Active, not recruiting
- Chang Gung Medical Foundation-Linkou Branch
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-
-
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Blackpool, United Kingdom, FY3 7EN
- Recruiting
- Layton Medical Centre
-
Contact:
- Phone Number: 441253951943
-
Principal Investigator:
- Rebecca Clark
-
Doncaster, United Kingdom, DN4 8QN
- Recruiting
- Clerkenwell Health - Doncaster
-
Principal Investigator:
- Ibreez Ajaz
-
Eastbourne, United Kingdom, BN23 5UZ
- Recruiting
- St Pancras Clinical Research - Eastbourne
-
Contact:
- Phone Number: 02038651142
-
Principal Investigator:
- Ward Lawrence
-
Glasgow, United Kingdom, G51 4TF
- Recruiting
- Queen Elizabeth University Hospital
-
Contact:
- Phone Number: (+44) 0141 232 7600
-
Principal Investigator:
- Nagore Penades
-
Hayle, United Kingdom, TR27 5DT
- Recruiting
- Mounts Bay Medical Hub
-
Principal Investigator:
- Richard Burkimsher
-
Hounslow, United Kingdom, TW4 7NR
- Recruiting
- HMC Health Group - Meadows Centre for Health
-
Principal Investigator:
- Ivor Singh
-
Contact:
- Phone Number: 07946732168
-
London, United Kingdom, EC2Y 8EA
- Recruiting
- St Pancras Clinical Research
-
Contact:
- Phone Number: 020 3865 1142
-
Principal Investigator:
- Graham Campbell
-
London, United Kingdom, W1U 6RP
- Recruiting
- Clerkenwell Health - London - Baker Street
-
Principal Investigator:
- Alishah Suleman
-
Newquay, United Kingdom, TR7 1RU
- Recruiting
- Newquay Health Centre
-
Principal Investigator:
- Nicholas Jacobsen
-
Contact:
- Phone Number: 01637 850002
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Preston, United Kingdom, PR2 9QB
- Recruiting
- Panthera Biopartners - Preston
-
Principal Investigator:
- Halah Almahdi
-
Rotherham, United Kingdom, S65 1DA
- Recruiting
- Wickersley Health Centre - Clifton Medical Centre
-
Contact:
- Phone Number: 01709363950
-
Principal Investigator:
- Matthew Capehorn
-
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Arizona
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Scottsdale, Arizona, United States, 85260
- Active, not recruiting
- Headlands Research - Scottsdale
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72211
- Active, not recruiting
- Woodland International Research Group
-
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California
-
Los Angeles, California, United States, 90095
- Active, not recruiting
- UCLA Clinical & Translational Research Center (CTRC)
-
Riverside, California, United States, 92503
- Active, not recruiting
- Artemis Institute for Clinical Research
-
San Diego, California, United States, 92123
- Active, not recruiting
- Artemis Institute for Clinical Research
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San Francisco, California, United States, 94158
- Active, not recruiting
- UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
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Florida
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Lakeland, Florida, United States, 33803
- Active, not recruiting
- Accel Research Sites - Lakeland Clinical Research Unit
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Lauderhill, Florida, United States, 33319
- Active, not recruiting
- Innovative Clinical Research
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Maitland, Florida, United States, 32751
- Active, not recruiting
- K2 Medical Research - Maitland
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Maitland, Florida, United States, 32751
- Active, not recruiting
- K2 Medical Research ORLANDO
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Miami, Florida, United States, 33126
- Active, not recruiting
- Life Arc Research Centers - Miami
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Miami, Florida, United States, 33135
- Active, not recruiting
- Wellness Research Center
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Miami Gardens, Florida, United States, 33014
- Active, not recruiting
- Life Medical Research Group Corp
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Orlando, Florida, United States, 32803
- Active, not recruiting
- Charter Research - Orlando
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Tampa, Florida, United States, 33634
- Active, not recruiting
- K2 Medical Research - Tampa
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Illinois
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Chicago, Illinois, United States, 60611
- Active, not recruiting
- Re:Cognition Health - Chicago
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Maryland
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Baltimore, Maryland, United States, 21229
- Active, not recruiting
- Maryland Treatment Centers - Mountain Manor Treatment Center
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Rockville, Maryland, United States, 20853
- Active, not recruiting
- Maryland Treatment Centers - Avery Road Treatment Center
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Massachusetts
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Boston, Massachusetts, United States, 02116
- Active, not recruiting
- Adams Clinical Boston
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Foxborough, Massachusetts, United States, 02035
- Active, not recruiting
- K2 Medical Research - Foxborough
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New York
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The Bronx, New York, United States, 10461
- Active, not recruiting
- Adams Clinical Bronx
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Active, not recruiting
- Penn Medicine: University of Pennsylvania Health System
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Active, not recruiting
- Brown University School of Public Health
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South Dakota
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Sioux Falls, South Dakota, United States, 57108
- Active, not recruiting
- Avera Research Institute - Sioux Falls
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Texas
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Dallas, Texas, United States, 75231
- Active, not recruiting
- Modern Research Associates, PLLC
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DeSoto, Texas, United States, 75115
- Active, not recruiting
- Adams Clinical Dallas
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Houston, Texas, United States, 77043
- Active, not recruiting
- Biopharma Informatic, LLC
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Virginia
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Fairfax, Virginia, United States, 22031
- Active, not recruiting
- Re:Cognition Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Note: Participants who are not able to perform the injections must receive assistance from a support person trained to administer the 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 or 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LY3537031 Period 1
Escalating doses administered subcutaneously (SC) |
Administered SC Administered SC
Other Names:
|
|
Experimental: LY3537031 Period 2
Administered SC |
Administered SC Administered SC
Other Names:
|
|
Placebo Comparator: Placebo
Administered SC |
Administered SC |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Time Frame: Up to 56 weeks
|
Up to 56 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Daily Alcohol Consumption as Assessed by the TLFB
Time Frame: Up to 56 weeks
|
Up to 56 weeks
|
|
Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)
Time Frame: Baseline up to Week 56
|
Baseline up to Week 56
|
|
Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Time Frame: Baseline up to Week 56
|
Baseline up to Week 56
|
|
Mean Change in Body Weight
Time Frame: Baseline up to Week 56
|
Baseline up to Week 56
|
|
Mean Change in Patient Reported Health Outcomes as Measured by Short Form 36, v2 (SF-36) Acute Form Domain and Component Summary Scores
Time Frame: Baseline up to Week 56
|
Baseline up to Week 56
|
|
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time Frame: Baseline up to Week 56
|
Baseline up to Week 56
|
|
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Time Frame: Baseline up to Week 56
|
Baseline up to Week 56
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 am - 8 pm Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27410
- 2025-522312-16-00 (Ctis)
- J2S-MC-GZMP (Other Identifier: Eli Lilly and Company)
- 2025 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.