Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Osteoarthritis
CompletedPhase 2NCT04456686
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study is being done to test the safety and efficacy of LY3016859 for the treatment of osteoarthritis pain. 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.
Study details
- Official title
- Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3016859 for the Treatment of Osteoarthritis
- Conditions
- Interventions
- Drug: LY3016859
- Drug: Placebo
- Sponsor
- Eli Lilly and Company
- Start date
- 2020-07-01
- Primary completion
- 2021-04-22
- Sex
- All
- Age range
- from 40 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Puerto Rico, United States
- Total sites listed
- 33
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening. * Have a history of daily pain for at least 12 weeks based on participant report or medical history. * Have a value of ≤30 on the pain catastrophizing scale. * Have a body mass index \<40 kilograms per meter squared (kg/m²) (inclusive). * Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation. * Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study. * Have presence of index knee pain for \>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. * Are men, or women able to abide by reproductive and contraceptive requirements. Exclusion Criteria: * Have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia. * Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques). * Have surgery planned during the study for any reason, related or not to the disease state under evaluation. * Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation. * There is an inability to rule out other causative or confounding sources of pain in the primary condition under study. * Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision. * Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association). * Have congenital QT prolongation or QT interval corrected for heart rate using Fridericia's formula (QTcF) interval measurement \>450 milliseconds (msec) for male participants, \>470 msec for female participants, or \>480 msec for participants with bundle branch block. * Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that cou…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04456686