Clinical trial for Osteoarthritis, Knee
Official title A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
ClinicalTrials.gov ID: NCT07641517
What this study is testing
What is LY4065967?
LY4065967 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for osteoarthritis, knee.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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...
- 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 likely can't join 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
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, 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
- 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
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Palm Springs, California, United States; Riverside, California, United States; San Diego, California, United States; Hamden, Connecticut, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.