A Phase 2 interventional study of LY3016859 ISA and LY3556050 ISA in Osteoarthritis, Knee, Diabetic Neuropathic Pain and Chronic Low-back Pain, sponsored by Eli Lilly and Company. Recruiting at 64 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Screening
The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.
The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing.
Note: Results for all outcomes are posted in the intervention records. No need for duplication.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants are randomized to receive either active LY3016859 or matching placebo
Drug: LY3016859 ISA · Drug: Placebo
Participants are randomized to receive either active LY3016859 or matching placebo
Drug: LY3016859 ISA · Drug: Placebo
Participants are randomized to receive either active LY3016859 or matching placebo
Drug: LY3016859 ISA · Drug: Placebo
Participants are randomized to receive either active LY3556050 or matching placebo
Drug: LY3556050 ISA · Drug: Placebo Oral
Participants are randomized to receive either active LY3556050 or matching placebo
Drug: LY3556050 ISA · Drug: Placebo Oral
Participants are randomized to receive either active LY3556050 or matching placebo
Drug: LY3556050 ISA · Drug: Placebo Oral
Participants are randomized to receive either active LY3526318 or matching placebo
Drug: LY3526318 ISA · Drug: Placebo Oral
Participants are randomized to receive either active LY3526318 or matching placebo
Drug: LY3526318 ISA · Drug: Placebo Oral
Participants are randomized to receive either active LY3526318 or matching placebo
Drug: LY3526318 ISA · Drug: Placebo Oral
Participants are randomized to receive either active LY3857210 or matching placebo
Drug: LY3857210 ISA · Drug: Placebo Oral
Participants are randomized to receive either active LY3857210 or matching placebo
Drug: LY3857210 ISA · Drug: Placebo Oral
Participants are randomized to receive either active LY3857210 or matching placebo
Drug: LY3857210 ISA · Drug: Placebo Oral
Participants are randomized to receive either active LY4065967 or matching placebo
Drug: Placebo Oral · Drug: LY4065967 ISA
Participants are randomized to receive either active LY4065967 or matching placebo
Drug: Placebo Oral · Drug: LY4065967 ISA
Participants are randomized to receive either active LY4065967 or matching placebo
Drug: Placebo Oral · Drug: LY4065967 ISA
Administered intravenously (IV)
Administered orally
Administered orally
Administered orally
Placebo administered orally
Placebo administered IV
Administered orally
Number of Participants Who Were Allocated to Each ISA
Time frame: Baseline, Up to Week 8
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Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Fepixnebart · LY3556050 · LY-3526318 · LY3857210 · LY4065967