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

NCT07641517

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Osteoarthritis, Knee, Chronic Pain

Interventions: LY4065967, Placebo

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (37)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Palm Springs, California, United States
  • Riverside, California, United States
  • San Diego, California, United States
  • Hamden, Connecticut, United States
  • Bradenton, Florida, United States
  • DeLand, Florida, United States
  • Lady Lake, Florida, United States
  • Maitland, Florida, United States
  • Merritt Island, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • New Port Richey, Florida, United States
  • Ocala, Florida, United States
  • Sunrise, Florida, United States
  • The Villages, Florida, United States
  • Winter Park, Florida, United States
  • Woodstock, Georgia, United States
  • Chicago, Illinois, United States
  • New Orleans, Louisiana, United States
  • New Bedford, Massachusetts, United States
  • Waltham, Massachusetts, United States
  • Bay City, Michigan, United States
  • City of Saint Peters, Missouri, United States
  • Springfield, Missouri, United States
  • Rochester, New York, United States
  • Fargo, North Dakota, United States
  • Dayton, Ohio, United States
  • + 7 more on CT.gov