Not Yet RecruitingPhase 2

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain

United States, Puerto Rico150 participantsStarted 2026-07

Plain-language summary

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of chronic low back pain (CLBP). 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation * Have a body mass index at screening of ≤40 kilograms per meter squared (kg/m²). * Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening Exclusion Criteria: * Are pregnant or breastfeeding * Have used a therapeutic injection to the spine in the 3 months prior to screening * Are using a spinal cord stimulator or dorsal root ganglion stimulator * Have ongoing complex regional pain syndrome or other concurrent medical conditions that could interfere with the evaluation of CLBP * Have a history of major spinal deformity, such as spondylolisthesis, spondylolysis, scoliosis, or spina bifida, that causes instability to the spine * Have an abnormal blood pressure (BP) systolic BP is greater than 140 millimeters mercury (\>140 mm Hg) and diastolic BP\>90 mm Hg at screening • Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is in Phase 2, which means it's still in relatively early testing — can you help me understand what that means for how much we'd know about LY4065967's safety and effectiveness before I'd be considering it?
2The trial isn't recruiting yet — do you have any sense of when it might open, and is it worth waiting for this study or should we be looking at treatment options available to me right now?
3The main thing this trial is measuring is how much my average pain score changes on a numeric rating scale — how meaningful is that kind of measurement in real life, and would a change in that score actually reflect feeling better day to day?
4LY4065967 appears to be a new investigational drug — do you know anything about how it works or what class of medication it is, so I can understand how it's different from pain treatments I might already be able to try?
5Given that this is still a Phase 2 study with no recruitment open yet, are there existing standard treatments for chronic low back pain that you think I should explore first before considering an experimental option like this?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)

Timeframe: Baseline, Week 8

Trial details

NCT IDNCT07641504

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

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

1-317-615-4559 LillyTrials@Lilly.com

View on ClinicalTrials.gov More Chronic Pain trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.