Last updated 8 days ago
A Study of Brenipatide in Participants With Alcohol Use Disorder
1100 patients around the world
Available in Argentina, United States
Eli Lilly and Company
16Research sites
1100Patients around the world
This study is for people with
Substance Use Disorders
Alcohol Use Disorder
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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.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.Complete the required questionnaires.
- 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.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).
Sites
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Instituto de Investigaciones Clínicas (IIC) - Rosario
Instituto Privado Kremer
Centro Médico Luquez
Globalpsy
Centro de Diagnóstico y Rehabilitación - CEDIR
Resolution Psychopharmacology Research Institute
StudyRENEW-ALC-2
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Alcohol Use Disorder
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07219953
