What is LY3016859 studying for chronic pain?

LY3016859 is being studied as one of several treatments for chronic pain conditions like osteoarthritis, diabetic neuropathic pain, and low back pain. This study evaluates how it compares to placebos in reducing pain and improving function. The trial is sponsored by Eli Lilly and Company and aims to better understand different pain interventions.

Who may be eligible for this chronic pain clinical trial?

Adults aged 18 years and older with chronic knee osteoarthritis, diabetic neuropathic pain, or low back pain may be eligible. Participants should have a certain level of pain and be willing to stop other pain medications except rescue drugs. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic pain clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05986292

A Master Protocol for Randomized, Placebo-Controlled Phase 2 Trials of Multiple Interventions for Chronic Pain

Led by Eli Lilly and Company · Updated on 2026-04-20

10000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a master protocol study to evaluate multiple independent pain treatments for people with chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different interventions within a structured framework that includes specific criteria and unique assessments for each condition. The study is designed as a randomized, placebo-controlled Phase 2 clinical trial to better understand these treatments. Participants are randomly assigned to receive one of several investigational drugs or matching placebos. These drugs include LY3016859, administered intravenously, and LY3556050, LY3526318, and LY3857210, all given orally. The interventions are organized in separate appendices focusing on each pain condition, allowing some to begin independently as they become available for testing. During the study, participants will be monitored from baseline up to 8 weeks to track allocation to each intervention-specific appendix. Researchers will assess pain levels, functional status, and safety through various scales and tests. The study involves maintaining stable non-drug therapies and discontinuing current pain medications except rescue medications. Participants will undergo physical exams, lab tests, and screening for medical history to ensure safety throughout the trial, which is led by Eli Lilly and Company and is expected to continue until April 2027.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Have a visual analog scale (VAS) pain value greater than 40 and less than 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 pain catastrophizing scale value of 0 or less
Have a body mass index less than 40 kg/m² (inclusive)
Willing to maintain a consistent regimen of ongoing nonpharmacologic pain-relieving therapies and not start new ones during the study
Willing to discontinue all medications for chronic pain conditions except rescue medication during study participation

You will not qualify if you...

Have second- or third-degree atrioventricular (AV) heart block, AV dissociation, or history of ventricular tachycardia
Have had a procedure in the past 6 months intended to produce permanent sensory loss in the target area (e.g., ablation)
Have surgery planned during the study for any reason
Have an acute, serious, or unstable medical condition or other illness that would prevent participation
Have had cancer within 2 years, except for certain resolved skin cancers
Have fibromyalgia
Have substance use disorder as defined by DSM-5
Have clinically important abnormalities in physical or neurological exam, vital signs, ECG, or lab tests
Have a positive HIV test at screening
Have a history of alcohol, illicit drug, analgesic, or narcotic use disorder within 2 years prior to screening

Research Team

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Physicians interested in becoming principal investigators please contact

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