Pain relief for knee osteoarthritis: a 2nd phase study of LY4065967 vs placebo
Official title: Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Osteoarthritis
Run by Eli Lilly and Company · NCT07641517 · Data updated 2026-11-12
Researchers are testing whether LY4065967 can help reduce knee pain from osteoarthritis in adults, compared with placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 36 sites (Birmingham, Alabama and 35 other locations) |
| Status | Recruiting |
| Started | June 25, 2026 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07641517 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with chronic knee OA pain, radiographic OA (Kellgren-Lawrence 2–4), BMI ≤40, stable HbA1c ≤10, and no recent knee procedures or implants.
✕Probably not a fit
Participants without knee pain improvement or with safety issues related to the drug may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2 interventional trial as part of a broader chronic pain master protocol. Participants have chronic knee pain due to osteoarthritis with radiographic confirmation and meet defined health criteria, including BMI and blood sugar controls. The study compares LY4065967 to placebo, assessing safety and efficacy over a set period. Enrollment takes place at several U.S. sites, with ongoing monitoring for knee-specific outcomes and overall health. The protocol aims to accelerate development of new treatments for chronic pain by using a standardized testing framework.
Why it matters
Potential benefit: If successful, participants may experience reduced knee pain and improved function.
How similar studies have gone: Prior studies in chronic pain protocols have shown potential benefits for similar investigational approaches, though results vary by drug.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
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Central Research Associates
Birmingham, Alabama, United States Recruiting -
Synexus Clinical Research US, Inc.
Phoenix, Arizona, United States Recruiting -
Arizona Research Center
Phoenix, Arizona, United States Recruiting -
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States Recruiting -
Artemis Institute for Clinical Research
Riverside, California, United States Recruiting -
Artemis Institute for Clinical Research
San Diego, California, United States Recruiting
Show 30 more locations
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CMR of Greater New Haven
Hamden, Connecticut, United States Recruiting -
Bradenton Research Center, Inc.
Bradenton, Florida, United States Recruiting -
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States Recruiting -
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, United States Recruiting -
K2 Medical Research ORLANDO
Maitland, Florida, United States Recruiting -
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States Recruiting -
Suncoast Research Group
Miami, Florida, United States Recruiting -
New Horizon Research Center
Miami, Florida, United States Recruiting -
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States Recruiting -
Renstar Medical Research
Ocala, Florida, United States Recruiting -
Precision Clinical Research
Sunrise, Florida, United States Recruiting -
Charter Research - Lady Lake
The Villages, Florida, United States Recruiting -
Conquest Research
Winter Park, Florida, United States Recruiting -
North Georgia Clinical Research
Woodstock, Georgia, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Recruiting -
DelRicht Research
New Orleans, Louisiana, United States Recruiting -
Lucida Clinical Trials
New Bedford, Massachusetts, United States Recruiting -
MedVadis Research Corporation
Waltham, Massachusetts, United States Recruiting -
Great Lakes Research Group, Inc.
Bay City, Michigan, United States Recruiting -
StudyMetrix Research
City of Saint Peters, Missouri, United States Recruiting -
Clinvest Research LLC
Springfield, Missouri, United States Recruiting -
Rochester Clinical Research, LLC
Rochester, New York, United States Recruiting -
Lillestol Research
Fargo, North Dakota, United States Recruiting -
META Medical Research Institute
Dayton, Ohio, United States Recruiting -
DelRicht Research
Tulsa, Oklahoma, United States Recruiting -
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States Recruiting -
FutureSearch Trials of Neurology
Austin, Texas, United States Recruiting -
Northwest Clinical Research Center
Bellevue, Washington, United States Recruiting -
Rainier Clinical Research Center
Renton, Washington, United States Recruiting -
Ponce Medical School Foundation Inc.
Ponce, Puerto Rico Recruiting
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.