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Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Osteoarthritis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Osteoarthritis Pain

NCT05080660•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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.
+11 more criteria

Locations (30)

Synexus- Chandler

Chandler, Arizona, United States

Synexus Clinical Research - Glendale

Glendale, Arizona, United States

Alliance for Multispecialty Research, LLC Tempe

Tempe, Arizona, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

CMR of Greater New Haven

Hamden, Connecticut, United States

VIN-Julie Schwartzbard

Aventura, Florida, United States

Suncoast Research Group

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Key Dates

Start Date

October 12, 2021

Primary Completion Date

June 6, 2022

Completion Date

June 6, 2022

Last Updated

July 17, 2024

Enrollment

160

ACTUAL participants

Conditions

OsteoarthritisOsteo Arthritis Knee

Interventions

LY3526318

DRUG

Placebo

DRUG

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

NCT07153471

Osteoarthritis

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RECRUITINGPHASE1

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

NCT07351968

Moderate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

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