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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Chronic Pain, Low Back Pain

In brief

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.

Key facts

Study ID

NCT07641504

Run by

Eli Lilly and Company

People needed

150

Starts

2026-07-01

Expected to finish

2027-04-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Central Research Associates — Birmingham, Alabama, United States
• Synexus Clinical Research US, Inc. — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• Artemis Institute for Clinical Research — Riverside, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• CMR of Greater New Haven — Hamden, Connecticut, United States
• Bradenton Research Center, Inc. — Bradenton, Florida, United States
• Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida, United States
• K2 MEDICAL Research THE VILLAGES — Lady Lake, Florida, United States
• K2 Medical Research ORLANDO — Maitland, Florida, United States
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States
• Suncoast Research Group — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Precision Clinical Research — Sunrise, Florida, United States
• Charter Research - Lady Lake — The Villages, Florida, United States
• Conquest Research — Winter Park, Florida, United States
• North Georgia Clinical Research — Woodstock, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• DelRicht Research — New Orleans, Louisiana, United States
• Lucida Clinical Trials — New Bedford, Massachusetts, United States
• MedVadis Research Corporation — Waltham, Massachusetts, United States
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States

Full record on ClinicalTrials.gov

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