Chronic Pain, Osteoarthritis, Knee
Conditions
Brief summary
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.
Interventions
DRUGLY4065967
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | Baseline, Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale | Baseline, week 8 |
| Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change | Baseline, Week 8 |
| Change From Baseline for Worst Pain Intensity as Measured by NRS | Baseline, Week 8 |
| Change From Baseline in the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) | Baseline, Week 8 |
| Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L) | Baseline, Week 8 |
| Total Amount of Rescue Medication Used Daily During the Treatment Phase | Baseline, Week 8 |
Countries
Puerto Rico, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed