A Study of LY2940094 in Participants With Alcohol Dependency

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce alcohol drinking in these participants. The study will last for 8 weeks.

Official Title
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Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial in Patients With Alcohol Dependence

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: LY2940094
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present with alcohol dependence (AD) defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR 303.9) Must have 3 to 6 heavy drinking days per week as assessed by the Timeline Follow Back (TLFB) scale at screening and baseline (heavy drinking is defined as greater than 4 drinks per day for females and greater than 5 drinks per day for males) Have a body mass index (BMI) between 18 and 35 kilograms per square meter (kg/m^2) Exclusion Criteria: Have had prior seizures or other condition that would place the participant at increased risk of seizures, and participants taking anticonvulsants for seizure control Have any other clinically significant medical condition or circumstance prior to randomization that, in the opinion of the investigator, could affect participant safety Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-IV) Axis I criteria for a lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar I disorder, or other psychoses

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2940094<br>40 mg LY2940094 oral tablet, QD for 8 weeks | Drug: LY2940094<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Identically matched placebo oral tablet, QD for 8 weeks | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 8 in the Average Number of Drinks per Day (NDD) Measured Over 28 Days |  | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 8 in Gammaglutamyl Transferase (GGT) |  | Baseline, Week 8 | 
| Percentage of Heavy Drinking Days per Month |  | Baseline and Week 8 | 
| Percentage of Days Abstinent per Month |  | Baseline and Week 8 | 
| Percentage of Participants with No (0) Heavy Drinking Days per Month |  | Baseline and Week 8 |