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LY2828360

Phase 2

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Eli Lilly and Company|Trials Updated: May 19, 2020

LY2828360 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2011

LY2828360 target and mechanism

Molecular targetCNR2
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

LY2828360 clinical trials

LY2828360 · 1 trial · 1 indication

Phase 2 1
NCT01319929A Study of LY2828360 in Patients With Osteoarthritic Knee PainOsteoarthritis, Knee
COMPLETED39 Analytics
PHASE2COMPLETED
A Study of LY2828360 in Patients With Osteoarthritic Knee Pain
Osteoarthritis, KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline to 4 Week Endpoint in Weekly Mean of Daily 24-Hour Average Pain Scores (APS)
Baseline, 4 weeks

The weekly mean of the 24-Hour APS was calculated from participants' daily entries for 24-hour average pain rating on an 11-point scale with scores from 0 (no pain) to 10 (worst possible pain). Data were recorded twice a day at approximately the same time each day, preferably first thing in the morning and in the afternoon.

Secondary Endpoints

Pharmacokinetics (PK) of LY2828360: Maximal Concentration (Cmax)
Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period)
Pharmacokinetics (PK) of LY2828360: Area Under the Concentration-Time Curve (AUC)
Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period)
Change From Baseline to 4 Week Endpoint in Weekly Mean of Night Pain and Worst Daily Pain Scores
Baseline, 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
LY2828360 then PlaceboEXPERIMENTAL80 milligrams (mg) of LY2828360 daily by mouth for 4 weeks: placebo daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments.
Placebo then LY2828360EXPERIMENTALPlacebo daily by mouth for 4 weeks: LY2828360 daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments.

Interventions

NameTypeDescription
LY2828360DRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Are male or female participants with osteoarthritis (OA), as determined by medical history and physical examination. Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the...

Countries:Denmark
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Competitive Landscape -Osteoarthritis 143 trials (matched to "Osteoarthritis, Knee")

Frequently asked questions about LY2828360

What is LY2828360 used for?

LY2828360 was studied for the treatment of knee osteoarthritis pain. It is an investigational small molecule developed by Eli Lilly and Company and has been evaluated in a Phase 2 clinical trial in patients with osteoarthritic knee pain. It is not described as an approved therapy.

What does LY2828360 target?

LY2828360 targets CNR2, the cannabinoid receptor 2, and acts as an agonist at this receptor. CNR2 is a G protein-coupled receptor, and LY2828360 was designed to activate it as a small molecule drug candidate.

Who makes LY2828360?

LY2828360 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 this compound.

What phase is LY2828360 in?

LY2828360 reached Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently listed as active. The compound is investigational and has not been described as approved for any indication.

What clinical trials is LY2828360 in?

LY2828360 was evaluated in the Phase 2 trial NCT01319929, titled A Study of LY2828360 in Patients With Osteoarthritic Knee Pain. The trial enrolled 39 patients, was randomized, double blind, and controlled, and was conducted in Denmark. It is now completed.