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LY2196044

Phase 2

Alcohol Dependence | Small molecule | Psychiatry |Eli Lilly and Company|Last Updated: Sep 24, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment375

FDA Designations

No designations recorded

Clinical trial landscape

LY2196044 · 1 trial · 1 indication

Phase 2 1
NCT00804570A Study for the Treatment of Alcohol DependenceAlcohol Dependence
COMPLETED375 Analytics
PHASE2COMPLETED
A Study for the Treatment of Alcohol Dependence
Alcohol DependenceUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Heavy Drinking Days at Week 16 Endpoint
Week 16

The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment\*visit, gender\*family history, baseline, and baseline\*visit. An unstructured covariance structure was used.

Secondary Endpoints

Change From Baseline in Drinks Per Day at Week 16 Endpoint
Baseline, Week 16
Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint
Baseline, Week 16
Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint
Baseline, Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY2196044EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
LY2196044DRUG250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
placeboDRUGonce daily, orally, 16 weeks
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Have Alcohol Dependence. Subjects must manifest at least the following 3 requirements for their diagnosis of Alcohol Dependence: 1. Be tolerant, as defined by either of the following: 1. A need for markedly increased amounts of alcohol to achieve intoxication or desir...

Countries:United States
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Frequently asked questions about LY2196044

What is LY2196044 used for?

LY2196044 is an investigational small molecule being studied for the treatment of alcohol dependence. It is being developed by Eli Lilly and Company for this psychiatric condition. The drug is currently in Phase 2 clinical development and is not approved for any use.

Who makes LY2196044?

LY2196044 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research on this investigational drug for the treatment of alcohol dependence.

What phase is LY2196044 in?

LY2196044 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial for the treatment of alcohol dependence has been completed, with no active trials currently ongoing.

What clinical trials is LY2196044 in?

LY2196044 has one completed clinical trial registered as NCT00804570, titled "A Study for the Treatment of Alcohol Dependence." This Phase 2 study enrolled 375 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults aged 21 years and older.

Is LY2196044 FDA approved?

LY2196044 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of alcohol dependence. The drug has completed one clinical trial but has not yet received regulatory approval for any indication.