Alcohol Use Disorder
Conditions
Brief summary
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.
Interventions
DRUGLY3537031
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB) | Up to 56 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in Daily Alcohol Consumption as Assessed by the TLFB | Up to 56 weeks |
| Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS) | Baseline up to Week 56 |
| Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score | Baseline up to Week 56 |
| Mean Change in Body Weight | 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 | Baseline up to Week 56 |
| Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide | Baseline up to Week 56 |
| Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA) | Baseline up to Week 56 |
Countries
Belgium, China, Germany, Japan, South Korea, Taiwan, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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
Outcome results
None listed