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Master Protocol Study of Multiple Interventions for Chronic Pain

This study, called a "master protocol," is looking at several different treatments for chronic pain, including pain from osteoarthritis of the knee, diabetic neuropathic pain, and chronic low-back pain. The treatments being tested are LY3016859 (given intravenously, meaning into a vein), and LY3556050, LY3526318, and LY3857210 (all given by mouth). Some participants will also receive a placebo (an inactive substance) by mouth. The main goal is to see how many participants are assigned to each treatment. You might be able to join if you are 18 or older, have had daily pain for at least 12 weeks, and your pain level is between 40 and 95 on a visual analog scale (VAS). The study is currently unclear about its recruitment status and plans to enroll up to 10,000 people.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is designed as a master protocol to compare independent pain interventions across different chronic pain conditions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at baseline and up to Week 8, which gives an idea of the follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05986292

A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Recruiting
PHASE2Ages 18+InterventionalScreening
Eli Lilly and Company
~10,000 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:LY3016859 ISALY3556050 ISALY3526318 ISALY3857210 ISAPlacebo OralPlacebo

At a glance

Recruiting sites
37 of 64 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Were Allocated to Each ISA
Measured over Baseline, Up to Week 8

Conditions

Osteoarthritis, Knee
Diabetic Neuropathic Pain
Chronic Low-back Pain

Explore related trials

Chronic low back painDiabetic Neuropathic PainOsteoarthritis

Where it's being run

64 sites across 25 states
Florida19
Texas5
Arizona4
California4
Massachusetts4
Ohio3
Alabama2
Illinois2

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
have a body mass index \<40 kilogram/square meter (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, except rescue medication for the duration of the study

Exclusion

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.
have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
have fibromyalgia
have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
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 a positive human immunodeficiency virus (HIV) test result at screening
have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.

What this trial measures

  • Number of Participants Who Were Allocated to Each ISABaseline, Up to Week 8