New drugs for knee osteoarthritis, diabetic nerve pain or back pain
Tests several new drugs in people with long-lasting pain.
Key facts
- Who runs it
- Eli Lilly and Company
- Where
- Ponce and San Juan, Puerto RicoSee the 2 sitesAlso in 1 other country, 62 sites
- Trial code
- Registry title
- A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 10,000 people, planned
- Started
- 30 Jan 2020
- Expected to end
- Apr 2027
- Type of study
- Interventional, 15 groups
- Treatments tested
- LY3016859 ISA
- LY3556050 ISA
- LY3526318 ISA
- LY3857210 ISA
- Placebo Oral
- Placebo
- LY4065967 ISA
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-lasting pain from knee osteoarthritis, diabetic nerve pain or chronic low back pain. It tests several new drugs against a placebo (dummy pill).
- Age
- 18 Years and older
- Sex
- All sexes
- Disease stage
- Daily pain for at least 12 weeks. Pain score on a visual analog scale (VAS) of ≥40 and <95 at screening.
- Earlier treatment
- People must stop all medicines for chronic pain during the study, except rescue medicine. They must keep any current non-drug pain therapies and supplements unchanged and start no new ones. No procedure in the past 6 months meant to cause permanent loss of feeling in the painful area (for example, ablation).
- Biomarker or test result
- A value of ≤30 on the pain catastrophizing scale (a questionnaire about thoughts on pain).
Main reasons for not taking part
- Second- or third-degree AV heart block, AV dissociation, or past ventricular tachycardia
- Cancer within 2 years, except skin basal or squamous cell cancer removed by surgery
- Fibromyalgia or surgery planned during the study
- Positive HIV test at screening
- Alcohol, drug, painkiller or narcotic use disorder within 2 years
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- have a visual analog scale (VAS) pain value ≥40 and <95 at screening and prerandomization 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
- are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation
- are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study
Who cannot take part
- have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening
- have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia
- 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
- have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision
- have a positive human immunodeficiency virus (HIV) test result at screening
- 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 could be detrimental to the participant or could compromise the study
- 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 fibromyalgia
Where in Puerto Rico
Also in 1 other country, 62 sites
- Ponce Medical School Foundation Inc.Ponce, Puerto RicoContact: Elizabeth Barranco-Santana (principal investigator)Taking people
- Latin Clinical Trial CenterSan Juan, Puerto RicoNo longer taking part
About the trial
What the trial wants to find out
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 15 groups in the trial
- LY3016859 Osteoarthritis ISATreatment being tested
Participants are randomized to receive either active LY3016859 or matching placebo
Treatment: LY3016859 ISA and Placebo
- LY3016859 Diabetic Neuropathic Pain ISATreatment being tested
Participants are randomized to receive either active LY3016859 or matching placebo
Treatment: LY3016859 ISA and Placebo
- LY3016859 Chronic Back Pain ISATreatment being tested
Participants are randomized to receive either active LY3016859 or matching placebo
Treatment: LY3016859 ISA and Placebo
- LY3556050 Osteoarthritis ISATreatment being tested
Participants are randomized to receive either active LY3556050 or matching placebo
Treatment: LY3556050 ISA and Placebo Oral
- LY3556050 Diabetic Neuropathic Pain ISATreatment being tested
Participants are randomized to receive either active LY3556050 or matching placebo
Treatment: LY3556050 ISA and Placebo Oral
- LY3556050 Chronic Back Pain ISATreatment being tested
Participants are randomized to receive either active LY3556050 or matching placebo
Treatment: LY3556050 ISA and Placebo Oral
- LY3526318 Osteoarthritis ISATreatment being tested
Participants are randomized to receive either active LY3526318 or matching placebo
Treatment: LY3526318 ISA and Placebo Oral
- LY3526318 Diabetic Neuropathic Pain ISATreatment being tested
Participants are randomized to receive either active LY3526318 or matching placebo
Treatment: LY3526318 ISA and Placebo Oral
- LY3526318 Chronic Back Pain ISATreatment being tested
Participants are randomized to receive either active LY3526318 or matching placebo
Treatment: LY3526318 ISA and Placebo Oral
- LY3857210 Osteoarthritis ISATreatment being tested
Participants are randomized to receive either active LY3857210 or matching placebo
Treatment: LY3857210 ISA and Placebo Oral
- LY3857210 Diabetic Neuropathic Pain ISATreatment being tested
Participants are randomized to receive either active LY3857210 or matching placebo
Treatment: LY3857210 ISA and Placebo Oral
- LY3857210 Chronic Back Pain ISATreatment being tested
Participants are randomized to receive either active LY3857210 or matching placebo
Treatment: LY3857210 ISA and Placebo Oral
- LY4065967 Chronic Low Back Pain ISATreatment being tested
Participants are randomized to receive either active LY4065967 or matching placebo
Treatment: Placebo Oral and LY4065967 ISA
- LY4065967 Osteoarthritis ISATreatment being tested
Participants are randomized to receive either active LY4065967 or matching placebo
Treatment: Placebo Oral and LY4065967 ISA
- LY4065967 Diabetic Neuropathic Pain ISATreatment being tested
Participants are randomized to receive either active LY4065967 or matching placebo
Treatment: Placebo Oral and LY4065967 ISA
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
- Plain-language title
- New drugs for knee osteoarthritis, diabetic nerve pain or back painGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Publications
- Record updated
- 5 November 2026