Alcohol Use Disorder study: LY3537031
Official title A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder
ClinicalTrials.gov ID: NCT07219966
What this study is testing
What is LY3537031?
This is an investigational injectable medicine being studied to see if it helps people with moderate-to-severe Alcohol Use Disorder.
Also referred to as Brenipatide.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if brenipatide is effective and safe compared to a placebo for treating moderate‑to‑severe alcohol use disorder.
- Who it's for
- Adults who have moderate‑to‑severe alcohol use disorder.
- What's involved
- Participants will receive either brenipatide or a placebo and attend scheduled study visits over the course of the trial.
- Time commitment
- The study lasts about 56 weeks, with regular visits as scheduled.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- self-inject study intervention
- store and use the provided blinded study intervention, as directed
You likely can't join if
- 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...
- 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...
- history of advanced liver disease, including advanced liver fibrosis [Stage 3] or cirrhosis [Stage 4], based on prior biomarkers, imaging or liver...
- history of acute 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...
See the full eligibility 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
- store and use the provided blinded study intervention, as directed
- maintain electronic and paper study diaries, as applicable, and
- 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...
- 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"...
- 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 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Rockville, Maryland, United States
- Dallas, Texas, United States
- Seongnam, South Korea
- Uijeongbu-si, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Rockville, Maryland, United States; Dallas, Texas, United States; Seongnam, South Korea; Uijeongbu-si, South Korea. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.