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LY2940094

Phase 2

Alcoholism | Small molecule | Psychiatry |Neumora Therapeutics, Inc.|Last Updated: Feb 3, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

LY2940094 · 4 trials · 3 indications

Phase 2 2Phase 1 2
NCT01798303A Study of LY2940094 in Participants With Alcohol DependencyAlcoholism
COMPLETED88 Analytics
NCT01724112Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)Major Depressive Disorder
COMPLETED136 Analytics
PHASE2COMPLETED
A Study of LY2940094 in Participants With Alcohol Dependency
AlcoholismUnlock trial analytics
PHASE2COMPLETED
Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline to Week 8 in the Average Number of Drinks per Day (NDD) Measured Over 28 Days
Baseline, Week 8
Change from Baseline to Week 8 on the GRID Hamilton Depression Rating Scale 17 Item Version (GRID-HAMD17) Total Score
Baseline, Week 8
Change from Baseline in Nociceptin/Orphanin FQ Peptide (NOP) Receptor Occupancy at Day 2
Baseline, Day 2 (occurs 1-4 weeks after baseline)
Number of participants with clinically significant effects
Baseline to study completion

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY2940094EXPERIMENTAL40 mg LY2940094 oral tablet, QD for 8 weeks
PlaceboPLACEBO_COMPARATORIdentically matched placebo oral tablet, QD for 8 weeks
Cohort 1: 40 milligram (mg) LY2940094EXPERIMENTAL40 mg LY2940094 was administered orally, one time only (it was originally expected that 100 mg LY2940094 would be administered). If the receptor occupancy (RO) for a given dose is lower than 50%, (time to maximum concentration \[tmax\] or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts.
Cohort 2: 10 mg LY2940094EXPERIMENTALThe dose levels for subjects in Cohort 2 will be defined based on the results of the receptor occupancy (RO) data of previous cohort and the ongoing review of safety data. This dose was determined to be 10 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts.
Cohort 3: 4 mg LY2940094EXPERIMENTALThe dose levels for subjects in Cohort 3 will be defined based on the results of the receptor occupancy (RO) data of previous cohort(s) and the ongoing review of safety data. This dose was determined to be 4 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts.
Cohort 4: 20 mg LY2940094EXPERIMENTALThe dose levels for subjects in Cohort 4 will be defined based on the results of the receptor occupancy (RO) data of previous cohort(s) and the ongoing review of safety data. This dose was determined to be 20 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts.
LY2940094 - single doseEXPERIMENTALSingle oral dose of 2-800 milligram (mg) LY2940094
LY2940094 - multiple doseEXPERIMENTALDaily oral dose of 2-200 mg LY2940094 for 14 days

Interventions

NameTypeDescription
LY2940094DRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

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 base...

Countries:United StatesCanada
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Frequently asked questions about LY2940094

What is LY2940094 used for?

LY2940094 is an investigational small molecule being studied for major depressive disorder, depression, and alcoholism. It has been evaluated in Phase 2 clinical trials for major depressive disorder and alcohol dependency. The drug is not approved and remains in clinical development.

Who makes LY2940094?

LY2940094 is being developed by Neumora Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NMRA. The drug has completed clinical trials in Canada and the United States.

What phase is LY2940094 in?

LY2940094 has completed Phase 2 clinical trials. It is an investigational drug and has not received FDA approval. The development program includes completed Phase 1 and Phase 2 studies in major depressive disorder, depression, and alcoholism.

What clinical trials is LY2940094 in?

LY2940094 has completed four clinical trials. These include NCT01263236 and NCT01404091, Phase 1 studies in healthy subjects, and NCT01724112 and NCT01798303, Phase 2 studies in major depressive disorder and alcohol dependency. All trials are completed.

Is LY2940094 the same as other drugs?

LY2940094 is the primary name for this investigational compound. No alternative names have been established in the clinical trial data. The drug is identified by this designation across all registered studies.