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Набира участници Фаза 3 NCT07219953

A Study of Brenipatide in Participants With Alcohol Use Disorder

Фаза 3 – широко изпитване преди одобрение
Заболявания: Alcohol Use Disorder

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
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.
Кой може да участва
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 a history of advanced liver disease (including advanced liver fibrosis or cirrhosis), or alcohol associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score. * 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).
Интервенции
LY3537031
DRUG
Placebo
DRUG
Места на провеждане 114
Белгия (5)
ANIMA Research
Diepenbeek
Kormont
Kluisbergen
Gezondheidshuis De Gloed
Machelen
Meclinas
Mechelen
Medisch Centrum Saffrou
Oudenaarde
Китай (27)
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing
Beijing HuiLongGuan Hospital
Beijing
The Second People's Hospital of Hunan Province
Changsha
The Second Xiangya Hospital of Central South University
Changsha
West China Hospital, Sichuan University
Cheng Du Shi
The Fourth People's Hospital of Chengdu
Chengdu
Guangzhou Brain Hospital
Guangzhou
The Seventh People's Hospital of Hangzhou
Hangzhou
Zhejiang Provincial People's Hospital
Hangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou
The Fourth Hospital of Harbin Medical University
Harbin
Hefei No.4 People's Hospital
Hefei
Huzhou Third Municipal Hospital
Huzhou
Shandong Mental Health Center
Jinan
First Affiliated Hospital of Kunming Medical University
Kunming
The Affilicated Kangning Hospital of Ningbo University
Ningbo
Shanghai Mental Health Center
Shanghai
Shenzhen Kangning Hospital
Shenzhen
The First Hospital of Hebei Medical University
Shijiazhuang
The Affiliated hospital of Southwest Medical University
Sichuan
Wuhu Hospital of Beijing Anding hospital
Wuhu
Xi An Mental Health Center
Xi'an
Xiamen Xianyue Hospital
Xiamen
Xianyang Hospital of Yan'an University
Xianyang
Psychiatric Hospital of Henan Province
Xinxiang
Zhenjiang Mental Health Center
Zhenjiang
Zhumadian Psychiatric Hospital
Zhumadian
Германия (7)
FutureMeds GmbH
Berlin
Velocity Clinical Research, Berlin
Berlin
Klinische Forschung Dresden
Dresden
Klinische Forschung Hamburg
Hamburg
Zentralinstitut für Seelische Gesundheit
Mannheim
Dedicated Research Site FutureMeds
Offenbach
Klinische forschung Schwerin GmbH
Schwerin
Япония (17)
Tokyo-Eki Center-building Clinic
Chūōku
Ai Sakura Clinic
Fukuoka
Hiro Mental Clinic
Fukuoka
Rainbow and Sea Hospital
Karatsu
Tatsuta Clinic
Kobe
Arata Clinic
Nagasaki
Yokogawa Ekimae Clinic
Nishi
Teine Keijinkai Hospital
Sapporo
NOT_YET_RECRUITING
Hillside Clinic Jingumae
Shibuya City
Samoncho Clinic
Shinjuku
Keiai Clinic
Shinjuku-ku
Higashi Shinjuku Clinic
Shinjuku-ku
Sakurazaka Clinic SophyAnce
Tokyo
Noguchi Naika Clinic
Tokyo
Tsukuba University Hospital
Tsukuba
Maekawa Medical Clinic
Yokohama
National Hospital Organization Hizen Psychiatric Medical Center
Yoshinogari-cho, Kanzaki-gun
Южна Корея (15)
Hallym University Sacred Heart Hospital
Anyang-si
NOT_YET_RECRUITING
Pusan National University Yangsan Hospital
Busan
NOT_YET_RECRUITING
Chungbuk National University Hospital
Cheongju-si
NOT_YET_RECRUITING
Hanyang University Guri Hospital
Guri-si
NOT_YET_RECRUITING
Inha University Hospital
Incheon
NOT_YET_RECRUITING
Kyungpook National University Hospital
Junggu
NOT_YET_RECRUITING
Gachon University Gil Medical Center
Namdong-gu
NOT_YET_RECRUITING
Konyang University Hospital
Seogu
NOT_YET_RECRUITING
Konyang University Hospital
Seogu
NOT_YET_RECRUITING
Seoul National University Bundang Hospital
Seongnam
NOT_YET_RECRUITING
Seoul National University Hospital
Seoul
NOT_YET_RECRUITING
Severance Hospital, Yonsei University Health System
Seoul
NOT_YET_RECRUITING
Hanyang University Seoul Hospital
Seoul
NOT_YET_RECRUITING
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul
NOT_YET_RECRUITING
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si
NOT_YET_RECRUITING
Taiwan (6)
Changhua Christian Hospital
Changhua County
NOT_YET_RECRUITING
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City
NOT_YET_RECRUITING
China Medical University Hospital
Taichung
NOT_YET_RECRUITING
Mackay Memorial Hospital
Taipei
NOT_YET_RECRUITING
Tri-Service General Hospital
Taipei
NOT_YET_RECRUITING
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
NOT_YET_RECRUITING
Великобритания (8)
Layton Medical Centre
Blackpool
Queen Elizabeth University Hospital
Glasgow
Mounts Bay Medical Hub
Hayle
HMC Health Group - Meadows Centre for Health
Hounslow
Clerkenwell Health - London - Baker Street
London
Newquay Health Centre
Newquay
Panthera Biopartners - Preston
Preston
Wickersley Health Centre - Clifton Medical Centre
Rotherham
САЩ (29)
Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore , Maryland
Adams Clinical Boston
Boston , Massachusetts
Re:Cognition Health - Chicago
Chicago , Illinois
Modern Research Associates, PLLC
Dallas , Texas
Adams Clinical Dallas
DeSoto , Texas
K2 Medical Research - East Providence
East Providence , Rhode Island
Re:Cognition Health
Fairfax , Virginia
Biopharma Informatic, LLC
Houston , Texas
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland , Florida
Innovative Clinical Research
Lauderhill , Florida
NOT_YET_RECRUITING
Woodland International Research Group
Little Rock , Arkansas
NOT_YET_RECRUITING
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles , California
K2 Medical Research - Maitland
Maitland , Florida
K2 Medical Research ORLANDO
Maitland , Florida
Life Arc Research Centers - Miami
Miami , Florida
Wellness Research Center
Miami , Florida
Life Medical Research Group Corp
Miami Gardens , Florida
North Star Medical Research
Middleburg Heights , Ohio
Charter Research - Orlando
Orlando , Florida
Penn Medicine: University of Pennsylvania Health System
Philadelphia , Pennsylvania
Brown University School of Public Health
Providence , Rhode Island
Artemis Institute for Clinical Research
Riverside , California
Maryland Treatment Centers - Avery Road Treatment Center
Rockville , Maryland
NOT_YET_RECRUITING
Artemis Institute for Clinical Research
San Diego , California
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco , California
Headlands Research - Scottsdale
Scottsdale , Arizona
Avera Research Institute - Sioux Falls
Sioux Falls , South Dakota
K2 Medical Research - Tampa
Tampa , Florida
Adams Clinical Bronx
The Bronx , New York
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
16.10.2025
Крайна дата
01.04.2028
Регистрационен номер
NCT07219953
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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