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

Purpose

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.

Conditions

  • Chronic Pain
  • Low Back Pain

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4065967 		LY4065967 administered orally.
  • Drug: LY4065967
    Administered orally.
Placebo Comparator
Placebo 		Placebo administered orally.
  • Drug: Placebo
    Administered orally

Recruiting Locations

Synexus Clinical Research US, Inc.
Phoenix, Arizona 85020

Arizona Research Center
Phoenix, Arizona 85053

Artemis Institute for Clinical Research
San Diego, California 92123

CMR of Greater New Haven
Hamden, Connecticut 06517

Bradenton Research Center, Inc.
Bradenton, Florida 34205

K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida 32159

K2 Medical Research ORLANDO
Maitland, Florida 32751

Merritt Island Medical Research, LLC
Merritt Island, Florida 32952

Suncoast Research Group
Miami, Florida 33135

New Horizon Research Center
Miami, Florida 33165

Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652

Renstar Medical Research
Ocala, Florida 34470

Precision Clinical Research
Sunrise, Florida 33351

Charter Research - Lady Lake
The Villages, Florida 32162

Conquest Research
Winter Park, Florida 32789

North Georgia Clinical Research
Woodstock, Georgia 30189
Contact:
678-494-5735

Northwestern University
Chicago, Illinois 60611

DelRicht Research
New Orleans, Louisiana 70115

Lucida Clinical Trials
New Bedford, Massachusetts 02740

MedVadis Research Corporation
Waltham, Massachusetts 02451

Great Lakes Research Group, Inc.
Bay City, Michigan 48706

StudyMetrix Research
City of Saint Peters, Missouri 63303

Clinvest Research LLC
Springfield, Missouri 65807

Lillestol Research
Fargo, North Dakota 58104

META Medical Research Institute
Dayton, Ohio 45432

DelRicht Research
Tulsa, Oklahoma 74133

Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635

Northwest Clinical Research Center
Bellevue, Washington 98007

Rainier Clinical Research Center
Renton, Washington 98057

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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