Chronic low back pain: test LY4065967 vs. placebo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, interventional trial as part of a broader chronic pain master protocol. Eligible adults with chronic low back pain for at least 3 months and BMI ≤ 40 kg/m² will be randomized to LY4065967 or placebo. The study evaluates safety and whether the drug helps relieve pain, within a framework designed to accelerate development of new chronic pain treatments. Participants must meet specific health criteria and not have certain spine or systemic conditions that could interfere with outcomes. Investigational sites are in Alabama and Arizona under Eli Lilly and Company as lead sponsor.

Why it matters

Who can join: the full rules

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

Where it's running

• Central Research Associates
  Birmingham, Alabama, United States Recruiting
• Synexus Clinical Research US, Inc.
  Phoenix, Arizona, United States Recruiting
• Arizona Research Center
  Phoenix, Arizona, United States Recruiting
• Desert Oasis Healthcare Medical Group
  Palm Springs, California, United States Recruiting
• Artemis Institute for Clinical Research
  Riverside, California, United States Recruiting
• Artemis Institute for Clinical Research
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.