Recent Updates
Recently added Catalysts

LY2828360

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about LY2828360

What is LY2828360 used for?

LY2828360 is an investigational small molecule being studied for the treatment of osteoarthritis of the knee. It was evaluated in a Phase 2 clinical trial for patients with osteoarthritic knee pain. The drug is not approved and remains in clinical development.

Who makes LY2828360?

LY2828360 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company conducted a Phase 2 trial of the drug in patients with osteoarthritic knee pain.

What phase is LY2828360 in?

LY2828360 is in Phase 2 clinical development. A Phase 2 trial of the drug for osteoarthritic knee pain has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is LY2828360 in?

LY2828360 has one completed clinical trial, registered as NCT01319929, titled "A Study of LY2828360 in Patients With Osteoarthritic Knee Pain." This Phase 2 study enrolled 39 participants in Denmark and was a randomized, double-blind, controlled trial.

How does LY2828360 work?

LY2828360 is a small molecule, but its specific molecular target has not been disclosed in available information. Therefore, its mechanism of action is not described here.