A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain (OA07)

June 8, 2026 updated by: Eli Lilly and Company

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Osteoarthritis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc.
        • Principal Investigator:
          • Elizabeth Barranco-Santana
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates
        • Principal Investigator:
          • David DeAtkine
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
        • Principal Investigator:
          • Louise Taber MD
      • Phoenix, Arizona, United States, 85020
        • Central Phoenix Medical Clinic
        • Principal Investigator:
          • Elysa Shaw
    • California
      • Palm Springs, California, United States, 92262
        • Desert Oasis Healthcare Medical Group
        • Principal Investigator:
          • Michael Jardula
      • Riverside, California, United States, 92503
        • Artemis Institute for Clinical Research
        • Principal Investigator:
          • Jack Vu
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
        • Principal Investigator:
          • Stacey Layle
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • CMR of Greater New Haven
        • Principal Investigator:
          • Joseph Soufer
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center, Inc.
        • Principal Investigator:
          • Eric Folkens
      • DeLand, Florida, United States, 32720
        • Accel Research Sites - Deland Clinical Research Unit
        • Principal Investigator:
          • Bruce Rankin
      • Lady Lake, Florida, United States, 32159
        • K2 MEDICAL Research THE VILLAGES
        • Principal Investigator:
          • Craig Curtis
      • Maitland, Florida, United States, 32751
        • K2 Medical Research ORLANDO
        • Principal Investigator:
          • Brandon Lenox
      • Merritt Island, Florida, United States, 32952
        • Merritt Island Medical Research, LLC
        • Principal Investigator:
          • David Kirk
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
        • Principal Investigator:
          • Lazaro Nunez
      • Miami, Florida, United States, 33135
        • Suncoast Research Group
        • Principal Investigator:
          • Mark Kutner
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
        • Principal Investigator:
          • Cathy Barnes
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
        • Principal Investigator:
          • David Oliver
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research
        • Principal Investigator:
          • Richard Linn
      • The Villages, Florida, United States, 32162
        • Charter Research - Lady Lake
        • Principal Investigator:
          • Stephen Miller
      • Winter Park, Florida, United States, 32789
        • Conquest Research
        • Principal Investigator:
          • Anand Patel
    • Georgia
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
        • Principal Investigator:
          • Bram Wieskopf
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
        • Principal Investigator:
          • Thomas Schnitzer
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
        • Principal Investigator:
          • Patrick Dennis
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Lucida Clinical Trials
        • Principal Investigator:
          • David Shih
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
        • Principal Investigator:
          • David DiBenedetto
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
        • Principal Investigator:
          • Jeffrey Potts
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
        • Principal Investigator:
          • Timothy Smith
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC
        • Principal Investigator:
          • Ralph Duda
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, LLC
        • Principal Investigator:
          • Patrick Connors
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research
        • Principal Investigator:
          • Michael Lillestol
    • Ohio
      • Dayton, Ohio, United States, 45432
        • META Medical Research Institute
        • Principal Investigator:
          • Priyesh Mehta
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • DelRicht Research
        • Principal Investigator:
          • Melita Tate
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
        • Principal Investigator:
          • Alan Kivitz
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology
        • Principal Investigator:
          • John Hudson
      • Fort Worth, Texas, United States, 76104
        • Re:Cognition Health - Fort Worth
        • Principal Investigator:
          • Claudia Perez
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
        • Principal Investigator:
          • Arifulla Khan, MD
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center
        • Principal Investigator:
          • Sheryl Marks

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered orally.
Drug: Placebo
Administered orally
Experimental: LY4065967
LY4065967 administered orally.
Drug: LY4065967
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Time Frame: Baseline, Week 8
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)
Time Frame: Baseline, Week 8
Baseline, Week 8
Change From Baseline in the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale
Time Frame: Baseline, week 8
Baseline, week 8
Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change
Time Frame: Baseline, Week 8
Baseline, Week 8
Change From Baseline for Worst Pain Intensity as Measured by NRS
Time Frame: Baseline, Week 8
Baseline, Week 8
Change From Baseline in the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Time Frame: Baseline, Week 8
Baseline, Week 8
Total Amount of Rescue Medication Used Daily During the Treatment Phase
Time Frame: Baseline, Week 8
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27369
  • H0P-MC-CPMP (Other Identifier: Eli Lilly and Company)
  • H0P-MC-OA07 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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