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

CompletedPhase 2NCT05080660
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of this study is to test safety and efficacy of study drug LY3526318 in for the treatment of knee pain due to with osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.

Study details

Official title
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Osteoarthritis Pain
Interventions
Sponsor
Eli Lilly and Company
Start date
2021-10-12
Primary completion
2022-06-06
Sex
All
Age range
from 40 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Puerto Rico, United States
Total sites listed
30

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening. * Have a history of daily pain for at least 12 weeks based on participant report or medical history. * Have a body mass index \<40 kilograms per meter squared (kg/m²) (inclusive). * Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation. * Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study. * Have presence of index knee pain for \>12 weeks at screening. * Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee. * Are men, or women able to abide by reproductive and contraceptive requirements. Exclusion Criteria: * 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). * Have surgery planned during the study for any reason, related or not to the disease state under evaluation. * Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation. * Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision. * Have fibromyalgia * Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association). * Have a positive human immunodeficiency virus (HIV) test result at screening. * Are in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide. * Have an intolerance to acetaminophen or paracetamol or any of its excipients. * Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening. * Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare. * Have presence of surgical hardware or other foreign body in the index knee. * Have an unstable index joint (such as a torn anterior cruciate ligament). * Have had a surgical procedure o…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05080660