Health TrialsbyHealthPanel

A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder

ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY3537031

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

1,100 Participants
are divided into 3 treatment groups
Group A: LY3537031 Period 1Experimental treatment 2 interventions
Group B: LY3537031 Period 2Experimental treatment 2 interventions
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)

Time frame
Up to 56 weeks

Secondary outcomes

1

Change in Daily Alcohol Consumption as Assessed by the TLFB

Time frame
Up to 56 weeks
2

Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)

Time frame
Baseline up to Week 56
3

Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score

Time frame
Baseline up to Week 56
4

Mean Change in Body Weight

Time frame
Baseline up to Week 56

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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