A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Recruiting · NCT07641517 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
LY4065967Placebo
What this trial is about
The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to 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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Have presence of index knee pain for more than 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
- Have a body mass index ≤40 kilograms per meter squared (kg/m²) (inclusive)
- Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening
Exclusion criteria
- Are pregnant or breastfeeding
- Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to screening
- Have presence of surgical hardware or other foreign body in the index knee
- Have ongoing complex regional pain syndrome or other concurrent medical condition that could interfere with the evaluation of pain in the index knee.
- Have had any joint replacement of the lower extremity, such as hip, knee or ankle, in the 6 months prior to screening
- Have an abnormal blood pressure (BP) (systolic BP greater than 140 millimeters mercury (\>140 mm Hg) and diastolic BP\>90 mm Hg) at screening
- Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator
Where it is running
37 locations listed across 18 US states.
- Central Research Associates - Birmingham, Alabama, United States
- Synexus Clinical Research US, Inc. - Phoenix, Arizona, United States
- Arizona Research Center - Phoenix, Arizona, United States
- Desert Oasis Healthcare Medical Group - Palm Springs, California, 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
- Bradenton Research Center, Inc. - Bradenton, Florida, United States
- Accel Research Sites - DeLand Clinical Research Unit - DeLand, Florida, United States
- K2 MEDICAL Research THE VILLAGES - Lady Lake, Florida, United States
- K2 Medical Research ORLANDO - Maitland, Florida, United States
- Merritt Island Medical Research, LLC - Merritt Island, Florida, United States
- Suncoast Research Group - Miami, Florida, United States
- New Horizon Research Center - Miami, Florida, United States
- Suncoast Clinical Research, Inc. - New Port Richey, Florida, United States
- Renstar Medical Research - Ocala, Florida, United States
- Precision Clinical Research - Sunrise, Florida, United States
- Charter Research - Lady Lake - The Villages, Florida, United States
- Conquest Research - Winter Park, Florida, United States
- North Georgia Clinical Research - Woodstock, Georgia, United States
- Northwestern University - Chicago, Illinois, United States
- DelRicht Research - New Orleans, Louisiana, United States
- Lucida Clinical Trials - New Bedford, Massachusetts, United States
- MedVadis Research Corporation - Waltham, Massachusetts, United States
- Great Lakes Research Group, Inc. - Bay City, Michigan, United States
- StudyMetrix Research - City of Saint Peters, Missouri, United States
- Clinvest Research LLC - Springfield, Missouri, United States
- Rochester Clinical Research, LLC - Rochester, New York, United States
- Lillestol Research - Fargo, North Dakota, United States
- META Medical Research Institute - Dayton, Ohio, United States
- DelRicht Research - Tulsa, Oklahoma, United States
- Altoona Center For Clinical Research - Duncansville, Pennsylvania, United States
- FutureSearch Trials of Neurology - Austin, Texas, United States
- Re:Cognition Health - Fort Worth - Fort Worth, Texas, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Rainier Clinical Research Center - Renton, Washington, United States
- Ponce Medical School Foundation Inc. - Ponce, Puerto Rico