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Clinical Trials in the USA / NCT07641504
Recruiting Phase 2

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

NCT07641504 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-08-12
Last updated
2026-09-04

Condition(s) studied

Chronic PainLow Back Pain

Investigational drug(s) / intervention(s)

LY4065967Placebo

LY4065967: Administered orally.

Placebo: Administered orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
Central Research Associates Birmingham Alabama Not Yet Recruiting
Synexus Clinical Research US, Inc. Phoenix Arizona Recruiting
Arizona Research Center Phoenix Arizona Recruiting
Desert Oasis Healthcare Medical Group Palm Springs California Not Yet Recruiting
Artemis Institute for Clinical Research Riverside California Recruiting
Artemis Institute for Clinical Research San Diego California Recruiting
CMR of Greater New Haven Hamden Connecticut Recruiting
Bradenton Research Center, Inc. Bradenton Florida Recruiting
Accel Research Sites - DeLand Clinical Research Unit DeLand Florida Recruiting
K2 MEDICAL Research THE VILLAGES Lady Lake Florida Recruiting
K2 Medical Research ORLANDO Maitland Florida Recruiting
Merritt Island Medical Research, LLC Merritt Island Florida Recruiting
Suncoast Research Group Miami Florida Recruiting
New Horizon Research Center Miami Florida Recruiting
Suncoast Clinical Research, Inc. New Port Richey Florida Recruiting
Renstar Medical Research Ocala Florida Recruiting
Precision Clinical Research Sunrise Florida Recruiting
Charter Research - Lady Lake The Villages Florida Recruiting
Conquest Research Winter Park Florida Recruiting
North Georgia Clinical Research Woodstock Georgia Recruiting
Northwestern University Chicago Illinois Recruiting
DelRicht Research New Orleans Louisiana Recruiting
Lucida Clinical Trials New Bedford Massachusetts Recruiting
MedVadis Research Corporation Waltham Massachusetts Recruiting
Great Lakes Research Group, Inc. Bay City Michigan Recruiting
StudyMetrix Research City of Saint Peters Missouri Recruiting
Clinvest Research LLC Springfield Missouri Recruiting
Rochester Clinical Research, LLC Rochester New York Not Yet Recruiting
Lillestol Research Fargo North Dakota Recruiting
META Medical Research Institute Dayton Ohio Recruiting
DelRicht Research Tulsa Oklahoma Recruiting
Altoona Center For Clinical Research Duncansville Pennsylvania Recruiting
FutureSearch Trials of Neurology Austin Texas Recruiting
Re:Cognition Health - Fort Worth Fort Worth Texas Not Yet Recruiting
Northwest Clinical Research Center Bellevue Washington Recruiting
Rainier Clinical Research Center Renton Washington Recruiting
Ponce Medical School Foundation Inc. Ponce Puerto Rico Not Yet Recruiting

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07641504 on ClinicalTrials.gov ↗ ← All trials in the USA