Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Osteoarthritis

H0P-MC-OA02 -

The purpose of this study is to test safety or efficacy of study drug LY3526318 in participants with osteoarthritis (OA) knee pain. This trial is part of the chronic pain master protocol (H0P-MC-CPMP) which is a protocol to accelerate the development of new treatments for chronic pain.

Trial Summary

Age Range
≥40 years
Conditions the trial is for
Arthritis
What the trial is testing?
LY356318
Could I receive a Placebo?
Yes
Enrollment Goal
160
Trial Dates
Oct 12, 2021 - Jun 6, 2022
How long will I be in the trial?
Your participation could last about 8 weeks and may include up to 5 visits to the study center.
Trial Phase
II

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have a body mass index <40 kilograms per meter squared (kg/m²)

  • Participants must be willing to maintain any non-drug pain relieving therapies (for example, physical therapy) and not start any new non-drug pain-relieving therapies during the study

  • Participants must be willing to stop all pain medications for osteoarthritis, except for rescue medication allowed in the study

  • Participants must have index knee pain for at least 12 weeks

Participants Must Not:

  • Participants must not have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques)

  • Participants must not have surgery planned during the study for any reason

  • Participants must not have had cancer within 2 years, except for certain types of skin cancer (cutaneous basal cell or squamous cell carcinoma) surgically removed

  • Participants must not have an intolerance to acetaminophen or paracetamol

  • Participants must not have an unstable index joint (such as a torn anterior cruciate ligament), surgical hardware or have had a surgical procedure or therapeutic injection in the affected knee within 3 months

  • Participants must not have had any joint replacement such as knee of the lower extremity, such as hip, knee or ankle, in the past 6 months

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