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LY2979165

Phase 1

Bipolar Disorder | Small molecule | Psychiatry |Eli Lilly and Company|Trials Updated: Jun 14, 2012

LY2979165 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Nov 2010

LY2979165 target and mechanism

Molecular targetGRM2
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment127

FDA Designations

No designations recorded

LY2979165 clinical trials

LY2979165 · 2 trials · 1 indication

Phase 1 2
NCT01383967A Study of LY2979165 in Healthy SubjectsBipolar Disorder
COMPLETED102 Analytics
NCT01248052A First Human Dose Study to Investigate Safety and Tolerability of LY2979165 in Healthy VolunteersBipolar Disorder
COMPLETED25 Analytics
PHASE1COMPLETED
A Study of LY2979165 in Healthy Subjects
Bipolar DisorderUnlock trial analytics
PHASE1COMPLETED
A First Human Dose Study to Investigate Safety and Tolerability of LY2979165 in Healthy Volunteers
Bipolar DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with clinically significant effects
Baseline to study completion (estimate of 5 months, study ran for 11 months)

Secondary Endpoints

Pharmacokinetics, area under the concentration curve (AUC): Part A
predose, up to 24 hours on day 1, predose and 4 hours on day 3, predose, up to 24 hours on day 7, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose,up to 48 hours on and after day 14
Pharmacokinetics, maximum concentration (Cmax): Part A
predose, up 24 hours on day 1, predose and 4 hours on day 3, predose, up to 24 hours on day 7, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose, up to 48 hours on and after day 14
Pharmacokinetics, area under the concentration curve (AUC): Part B
predose, up to 24 hours on day 1, predose and 4 hours on day 3, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose, up to 48 hours on and after day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY2979165 Part A, Cohort 1EXPERIMENTAL20 mg LY2979165 administered orally, daily for 14 days
LY2979165 Part A, Cohort 2EXPERIMENTAL60 mg LY2979165 administered orally, daily for 14 days
LY2979165 Part A, Cohort 3EXPERIMENTAL100 mg LY2979165 administered, orally daily for 14 days
LY2979165 Part A, Cohort 4EXPERIMENTAL150 mg LY2979165 administered orally, daily for 14 days
LY2979165 Part B, Cohort 5EXPERIMENTALDose to be determined by safety review of doses administered in Part A, administered, orally daily for 14 days
PlaceboPLACEBO_COMPARATORAdministered orally, daily for 14 days in a ratio of 3:1 in each Cohort of Part A
LY2979165 Part A, Cohort 6EXPERIMENTAL250 mg LY2979165 administered orally, daily for 14 days
LY2979165 Part A, Cohort 7EXPERIMENTAL400 mg LY2979165 administered orally, daily for 14 days
LY2979165 (Part A)EXPERIMENTALsingle oral doses at dose levels ranging from 20 to 1000 mg
Placebo (Part A)PLACEBO_COMPARATORsingle oral dose
LY2979165 - low dose (Part B)EXPERIMENTALsingle oral low dose of LY297165 (dose to be determined by Part A)
LY2979165 - high dose (Part B)EXPERIMENTALsingle oral high dose of LY2979165 (dose determined from Part A)
Placebo - Part BPLACEBO_COMPARATORsingle oral dose

Interventions

NameTypeDescription
LY2979165DRUGAdministered orally
placeboDRUGAdministered orally
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination. Female subjects for Part B (if performed) are at the site's discretion. * Male subjects: Agree to use a reliable method of birth control during the study * Female subjects: Women n...

Countries:Singapore
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Frequently asked questions about LY2979165

What is LY2979165?

LY2979165 is an investigational small molecule developed by Eli Lilly and Company for bipolar disorder. It is a Phase 1 clinical candidate and has not been approved for any indication. Both of its recorded clinical trials have been completed, and no trials are currently active.

What does LY2979165 target?

LY2979165 targets GRM2, also known as the metabotropic glutamate receptor 2. It acts as an agonist at this receptor. GRM2 agonism is the mechanism under study for its development in bipolar disorder, though the compound remains in early-stage clinical testing.

Who makes LY2979165?

LY2979165 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating the compound in bipolar disorder.

What phase is LY2979165 in?

LY2979165 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. Two Phase 1 trials have been completed, and there are no active trials of LY2979165 at this time.

What clinical trials is LY2979165 in?

Two completed Phase 1 trials have evaluated LY2979165: NCT01383967, which enrolled 102 healthy subjects, and NCT01248052, a first-in-human dose study that enrolled 25 healthy volunteers. Both were conducted in Singapore. Together they enrolled 127 participants, and both were randomized, double-blind, and placebo-controlled.

Is LY2979165 tested in healthy volunteers?

Yes. Both completed Phase 1 trials of LY2979165, NCT01383967 and NCT01248052, enrolled healthy volunteers rather than patients with bipolar disorder. Participants were 21 years of age or older, and the studies took place in Singapore. The trials assessed safety and tolerability of the compound.