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LY686017

Phase 2

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

LY686017 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Sep 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment375

FDA Designations

No designations recorded

LY686017 clinical trials

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 being developed by Eli Lilly and Company for use in psychiatry. The drug is currently in Phase 2 clinical development and is not approved by the FDA.

What does LY686017 target?

LY686017 is a small molecule developed by Eli Lilly and Company. Its specific molecular target has not been disclosed in available information. The drug is being investigated for its effects on alcohol dependence and social phobia, but the exact 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 New York Stock Exchange 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 is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 2 trials have been completed, one for social phobia and one for alcohol dependence, but the drug is not yet available commercially.

What clinical trials is LY686017 in?

LY686017 has been studied in two completed Phase 2 clinical trials. NCT00191022 compared LY686017 with a marketed drug in 185 patients with social phobia in the United States. NCT00805441 studied LY686017 in 190 patients with alcohol dependence in the United States. Both trials were randomized, double-blind, and placebo-controlled.

Is LY686017 the same as any other drug?

LY686017 is an investigational compound with no alternative names listed in available information. It is being developed by Eli Lilly and Company for alcohol dependence and social phobia. As a Phase 2 investigational drug, it is not yet marketed under any brand name.