A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
BP07
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Chronic Low Back Pain
3 other identifiers
interventional
150
2 countries
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 chronic-pain
Started Aug 2026
Shorter than P25 for phase_2 chronic-pain
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedStudy Start
First participant enrolled
August 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
September 4, 2026
September 1, 2026
8 months
June 8, 2026
September 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Baseline, Week 8
Secondary Outcomes (6)
Change from Baseline in Mean Overall Improvement as Measured by Patient Global Impression of Change (PGI-C)
Baseline, Week 8
Change from Baseline in Worst Pain Intensity as Measured by NRS
Baseline, Week 8
Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Baseline, Week 8
Total Amount of Rescue Medication Used Daily During the Treatment Phase
Week 8
Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)
Baseline, Week 8
- +1 more secondary outcomes
Study Arms (2)
LY4065967
EXPERIMENTALLY4065967 administered orally.
Placebo
PLACEBO COMPARATORPlacebo administered orally.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Central Research Associates
Birmingham, Alabama, 35205, United States
Synexus Clinical Research US, Inc.
Phoenix, Arizona, 85020, United States
Arizona Research Center
Phoenix, Arizona, 85053, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
CMR of Greater New Haven
Hamden, Connecticut, 06517, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720, United States
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, 32159, United States
K2 Medical Research ORLANDO
Maitland, Florida, 32751, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
Suncoast Research Group
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Conquest Research
Winter Park, Florida, 32789, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Northwestern University
Chicago, Illinois, 60611, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
META Medical Research Institute
Dayton, Ohio, 45432, United States
DelRicht Research
Tulsa, Oklahoma, 74133, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Re:Cognition Health - Fort Worth
Fort Worth, Texas, 76104, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2026
First Posted
June 11, 2026
Study Start
August 12, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
September 4, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.