A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorEli Lilly and Company
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- LY4065967
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov