A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
OA07
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Osteoarthritis
3 other identifiers
interventional
150
2 countries
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2026
Shorter than P25 for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
Study Completion
Last participant's last visit for all outcomes
April 1, 2027
June 11, 2026
January 1, 2026
9 months
June 8, 2026
June 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Baseline, Week 8
Secondary Outcomes (6)
Change From Baseline in the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale
Baseline, week 8
Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change
Baseline, Week 8
Change From Baseline for Worst Pain Intensity as Measured by NRS
Baseline, Week 8
Change From Baseline in the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Baseline, Week 8
Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)
Baseline, Week 8
- +1 more secondary outcomes
Study Arms (2)
LY4065967
EXPERIMENTALLY4065967 administered orally.
Placebo
PLACEBO COMPARATORPlacebo administered orally.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Central Research Associates
Birmingham, Alabama, 35205, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020, United States
Arizona Research Center
Phoenix, Arizona, 85053, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
CMR of Greater New Haven
Hamden, Connecticut, 06517, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720, United States
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, 32159, United States
K2 Medical Research ORLANDO
Maitland, Florida, 32751, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
Suncoast Research Group
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Conquest Research
Winter Park, Florida, 32789, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Northwestern University
Chicago, Illinois, 60611, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
META Medical Research Institute
Dayton, Ohio, 45432, United States
DelRicht Research
Tulsa, Oklahoma, 74133, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Re:Cognition Health - Fort Worth
Fort Worth, Texas, 76104, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2026
First Posted
June 11, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
June 11, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.