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New treatment option for Alcohol Use Disorder
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?
LY3537031 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for 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 purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.
- 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...
- 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...
- 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"...
- 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 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's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Lakeland, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Rockville, Maryland, United States
- Boston, Massachusetts, United States
- Foxborough, Massachusetts, United States
- The Bronx, New York, United States
- Middleburg Heights, Ohio, United States
+ 81 more site(s).
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 - 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?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States and 95 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.