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LY3537031

Phase 3

Alcohol Use Disorder | Small molecule | Other |Eli Lilly and Company|Last Updated: Jun 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment2,200
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07219953A Study of Brenipatide in Participants With Alcohol Use DisorderPHASE3 RECRUITING 1,100Oct 16, 2025Apr 1, 2028Jun 3, 2026119 United States, Belgium +6
NCT07219966A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use DisorderPHASE3 RECRUITING 1,100Oct 15, 2025Apr 1, 2028Jun 3, 2026123 United States, Belgium +6
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Study Endpoints
Primary Endpoints
Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Up to 56 weeks
Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3537031 Period 1EXPERIMENTALEscalating doses administered subcutaneously (SC)
LY3537031 Period 2EXPERIMENTALAdministered SC
PlaceboPLACEBO_COMPARATORAdministered SC
Interventions
NameTypeDescription
LY3537031DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites119

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 vis...

Countries:United StatesBelgiumChinaGermanyJapanSouth KoreaTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 3, 2026NCT07219953lastUpdatePostDate: changed
LOWJun 3, 2026NCT07219966lastUpdatePostDate: changed
LOWJun 3, 2026NCT07219953lastUpdatePostDate: changed
LOWJun 3, 2026NCT07219966lastUpdatePostDate: changed
LOWMay 26, 2026NCT07219953primaryCompletionDate: changed
LOWMay 26, 2026NCT07219966primaryCompletionDate: changed
LOWMay 24, 2026NCT07219953studyFirstPostDate: changed
LOWMay 24, 2026NCT07219966studyFirstPostDate: changed