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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,100
Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Time frame: Up to 56 weeks
Change in Daily Alcohol Consumption as Assessed by the TLFB
Time frame: Up to 56 weeks
Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)
Time frame: Baseline up to Week 56
Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Time frame: Baseline up to Week 56
Mean Change in Body Weight
Time frame: 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
Time frame: Baseline up to Week 56
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Baseline up to Week 56
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Time frame: Baseline up to Week 56
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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