A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Purpose
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.
Conditions
- Osteoarthritis, Knee
- Chronic Pain
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental LY4065967 |
LY4065967 administered orally. |
|
|
Placebo Comparator Placebo |
Placebo administered orally. |
|
Recruiting Locations
Synexus Clinical Research US, Inc.
Phoenix, Arizona 85020
Phoenix, Arizona 85020
Arizona Research Center
Phoenix, Arizona 85053
Phoenix, Arizona 85053
Desert Oasis Healthcare Medical Group
Palm Springs, California 92262
Palm Springs, California 92262
Artemis Institute for Clinical Research
Riverside, California 92503
Riverside, California 92503
Artemis Institute for Clinical Research
San Diego, California 92123
San Diego, California 92123
CMR of Greater New Haven
Hamden, Connecticut 06517
Hamden, Connecticut 06517
Bradenton Research Center, Inc.
Bradenton, Florida 34205
Bradenton, Florida 34205
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida 32720
DeLand, Florida 32720
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida 32159
Lady Lake, Florida 32159
K2 Medical Research ORLANDO
Maitland, Florida 32751
Maitland, Florida 32751
Merritt Island Medical Research, LLC
Merritt Island, Florida 32952
Merritt Island, Florida 32952
Suncoast Research Group
Miami, Florida 33135
Miami, Florida 33135
New Horizon Research Center
Miami, Florida 33165
Miami, Florida 33165
Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652
New Port Richey, Florida 34652
Renstar Medical Research
Ocala, Florida 34470
Ocala, Florida 34470
Precision Clinical Research
Sunrise, Florida 33351
Sunrise, Florida 33351
Charter Research - Lady Lake
The Villages, Florida 32162
The Villages, Florida 32162
Conquest Research
Winter Park, Florida 32789
Winter Park, Florida 32789
North Georgia Clinical Research
Woodstock, Georgia 30189
Woodstock, Georgia 30189
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
DelRicht Research
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
Lucida Clinical Trials
New Bedford, Massachusetts 02740
New Bedford, Massachusetts 02740
MedVadis Research Corporation
Waltham, Massachusetts 02451
Waltham, Massachusetts 02451
Great Lakes Research Group, Inc.
Bay City, Michigan 48706
Bay City, Michigan 48706
StudyMetrix Research
City of Saint Peters, Missouri 63303
City of Saint Peters, Missouri 63303
Clinvest Research LLC
Springfield, Missouri 65807
Springfield, Missouri 65807
Rochester Clinical Research, LLC
Rochester, New York 14609
Rochester, New York 14609
Lillestol Research
Fargo, North Dakota 58104
Fargo, North Dakota 58104
META Medical Research Institute
Dayton, Ohio 45432
Dayton, Ohio 45432
DelRicht Research
Tulsa, Oklahoma 74133
Tulsa, Oklahoma 74133
Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635
Duncansville, Pennsylvania 16635
FutureSearch Trials of Neurology
Austin, Texas 78731
Austin, Texas 78731
Re:Cognition Health - Fort Worth
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Northwest Clinical Research Center
Bellevue, Washington 98007
Bellevue, Washington 98007
Rainier Clinical Research Center
Renton, Washington 98057
Renton, Washington 98057
Ponce Medical School Foundation Inc.
Ponce, Puerto Rico 00716
Ponce, Puerto Rico 00716
More Details
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
LillyTrials@Lilly.com