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LY686017

Phase 2

Alcohol Dependence | Small molecule | Psychiatry |Eli Lilly and Company|Last Updated: Sep 17, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment190

FDA Designations

No designations recorded

Clinical trial landscape

LY686017 · 2 trials · 2 indications

Phase 2 2
NCT00805441A Study in the Treatment of Alcohol Dependence.Alcohol Dependence
COMPLETED190 Analytics
NCT00191022Comparison of LY686017 With a Marketed Drug in the Treatment of Social Anxiety DisorderSocial Phobia
COMPLETED185 Analytics
PHASE2COMPLETED
A Study in the Treatment of Alcohol Dependence.
Alcohol DependenceUnlock trial analytics
PHASE2COMPLETED
Comparison of LY686017 With a Marketed Drug in the Treatment of Social Anxiety Disorder
Social PhobiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Heavy Drinking Days
Baseline, Weeks 4 and 8 and 12 and 16

The Alcohol Timeline Followback (TLFB) is used in calculating the percent reduction in heavy drinking days. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day during last 4 weeks. One standard drink on the TLFB was defined as: 12 ounce (oz) beer \[5% alcohol by volume (abv)\], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.

Superiority is defined as a statistically greater reduction of the mean change from baseline to endpoint (after 12 weeks of treatment) in the Liebowitz Social Anxiety Scale (LSAS) total score.

Secondary Endpoints

Percent Days Abstinent Per Month
Baseline and Weeks 4 and 8 and 12 and 16.
Number of Drinks Per Drinking Day During a Month
Baseline and Weeks 4 and 8 and12 and 16
Time to First Heavy Drinking Day
Baseline up to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
LY686017EXPERIMENTAL -

Interventions

NameTypeDescription
LY686017DRUG50 milligrams (mg) daily by oral route for 12 weeks
PlaceboDRUGDaily by oral route for 12 weeks
paroxetineDRUG -
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Have Alcohol Dependence. * Are men or women who are ambulatory outpatients between 21 to 65 years of age (inclusive) showing evidence of living in a non-custodial stable residence and with no plans to move during the next 5 months. * Females of childbearing potential (not surg...

Countries:United States
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Frequently asked questions about LY686017

What is LY686017 used for?

LY686017 is an investigational small molecule being studied for the treatment of alcohol dependence and social phobia, also known as social anxiety disorder. It is in Phase 2 clinical development and has not been approved by the FDA.

What does LY686017 target?

The specific molecular target of LY686017 has not been disclosed in available information. It is a small molecule being investigated for its effects on alcohol dependence and social phobia, but its mechanism of action is not publicly detailed.

Who makes LY686017?

LY686017 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is currently in Phase 2 clinical trials for alcohol dependence and social phobia.

What phase is LY686017 in?

LY686017 is in Phase 2 clinical development. It has completed two Phase 2 trials, one for social phobia and one for alcohol dependence, but it is not yet approved and remains investigational.

What clinical trials is LY686017 in?

LY686017 has been studied in two completed Phase 2 trials. NCT00191022 compared it with a marketed drug in 185 patients with social phobia, and NCT00805441 studied it in 190 patients with alcohol dependence. Both trials were conducted in the United States.

Is LY686017 the same as any other drug?

No alternative names for LY686017 have been disclosed. It is identified solely by its investigational code LY686017 in clinical trial registries and available information.