RecruitingPhase 2interventionalRules rewrite

Phase 2: testing LY4065967 for Osteoarthritis, Knee

The main purpose of this study is to test the safety and how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07641517 · Eli Lilly and Company · enrollment listed as 150

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are LY4065967, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to test the safety and how well it works of study drug for the treatment of knee pain due to osteoarthritis (OA).

They plan to enroll about 150 people at 36 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: LY4065967, Placebo

Primary outcome (registry wording): Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)

Who it is for (from inclusion criteria)

Ages 40 Years to any
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

Who the registry excludes

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

Public study contact (from the registry)

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

36 listed

Central Research Associates — Birmingham, Alabama (recruiting)
Synexus Clinical Research US, Inc. — Phoenix, Arizona (recruiting)
Arizona Research Center — Phoenix, Arizona (recruiting)
Desert Oasis Healthcare Medical Group — Palm Springs, California (recruiting)
Artemis Institute for Clinical Research — Riverside, California (recruiting)
Artemis Institute for Clinical Research — San Diego, California (recruiting)
CMR of Greater New Haven — Hamden, Connecticut (recruiting)
Bradenton Research Center, Inc. — Bradenton, Florida (recruiting)
Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida (recruiting)
K2 MEDICAL Research THE VILLAGES — Lady Lake, Florida (recruiting)
K2 Medical Research ORLANDO — Maitland, Florida (recruiting)
Merritt Island Medical Research, LLC — Merritt Island, Florida (recruiting)

+ 1 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07641517 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07641517?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07641517?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary