A Study of LY2940094 in Participants With Alcohol Dependency

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01798303

Enrollment

Registered

2013-02-25

Start date

2013-07-31

Completion date

2014-06-30

Last updated

2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

Brief summary

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.

Interventions

DRUGLY2940094

Administered orally

DRUGPlacebo

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026