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

Lilly

Status and phase: Begins enrollment this month; Phase 2

Conditions: Chronic Pain; Osteoarthritis, Knee

Treatments: Drug: LY4065967; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07641517

27369

H0P-MC-CPMP (Other Identifier)

H0P-MC-OA07 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

LY4065967

Experimental group

Description:

LY4065967 administered orally.

Treatment:

Drug: LY4065967

Placebo

Placebo Comparator group

Description:

Placebo administered orally.

Treatment:

Drug: Placebo