Chronic PainPhase 2BP07NCT07641504
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
A Phase 2 study testing LY4065967 in people with Chronic Pain and Low Back Pain, run by Eli Lilly and Company at 36 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Low Back Pain
- What is being tested?
- LY4065967
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 12 Aug 2026to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
36 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
36 sites in 2 countries
United States35 sites, 35 recruiting
- Recruiting
FutureSearch Trials of Neurology
Austin, Texas, 78731
John Hudson
- Recruiting
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Jeffrey Potts
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
Arifulla Khan, MD
- Recruiting
Central Research Associates
Birmingham, Alabama, 35205
David DeAtkine
- Recruiting
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
Eric Folkens
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Thomas Schnitzer
- Recruiting
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Timothy Smith
- Recruiting
META Medical Research Institute
Dayton, Ohio, 45432
Priyesh Mehta
- Recruiting
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720
Bruce Rankin
- Recruiting
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Alan Kivitz
- Recruiting
Lillestol Research
Fargo, North Dakota, 58104
Michael Lillestol
- Recruiting
CMR of Greater New Haven
Hamden, Connecticut, 06517
Joseph Soufer
- Recruiting
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, 32159
Craig Curtis
- Recruiting
K2 Medical Research ORLANDO
Maitland, Florida, 32751
Brandon Lenox
- Recruiting
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952
David Kirk
- Recruiting
Suncoast Research Group
Miami, Florida, 33135
Mark Kutner
- Recruiting
New Horizon Research Center
Miami, Florida, 33165
Lazaro Nunez
- Recruiting
Lucida Clinical Trials
New Bedford, Massachusetts, 02740
David Shih
- Recruiting
DelRicht Research
New Orleans, Louisiana, 70115
Patrick Dennis
- Recruiting
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Cathy Barnes
- Recruiting
Renstar Medical Research
Ocala, Florida, 34470
David Oliver
- Recruiting
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262
Michael Jardula
- Recruiting
Synexus Clinical Research US, Inc.
Phoenix, Arizona, 85020
Shawn Searle
- Recruiting
Arizona Research Center
Phoenix, Arizona, 85053
Louise Taber MD
- Recruiting
Rainier Clinical Research Center
Renton, Washington, 98057
Sheryl Marks
- Recruiting
Artemis Institute for Clinical Research
Riverside, California, 92503
Jack Vu
- Not yet recruiting
Rochester Clinical Research, LLC
Rochester, New York, 14609
Patrick Connors
- Recruiting
Artemis Institute for Clinical Research
San Diego, California, 92123
Stacey Layle
- Recruiting
Clinvest Research LLC
Springfield, Missouri, 65807
Ralph Duda
- Recruiting
Precision Clinical Research
Sunrise, Florida, 33351
Richard Linn
- Recruiting
Charter Research - Lady Lake
The Villages, Florida, 32162
Stephen Miller
- Recruiting
DelRicht Research
Tulsa, Oklahoma, 74133
Melita Tate
- Recruiting
MedVadis Research Corporation
Waltham, Massachusetts, 02451
David DiBenedetto
- Recruiting
Conquest Research
Winter Park, Florida, 32789
Anand Patel
- Recruiting
North Georgia Clinical Research
Woodstock, Georgia, 30189
678-494-5735
Bram Wieskopf
Puerto Rico1 site, 1 recruiting
- Not yet recruiting
Ponce Medical School Foundation Inc.
Ponce, 00716
Elizabeth Barranco-Santana
About this study
Official title: Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Chronic Low Back Pain
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
- Being tested
- LY4065967, Placebo
- Medical subject headings
- Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4065967Drug
Administered orally.
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY4065967 | Experimental | LY4065967 administered orally. Receives: Drug: LY4065967 |
| Placebo | Placebo comparator | Placebo administered orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Measured: Baseline, Week 8
Secondary outcomes (6)
Change from Baseline in Mean Overall Improvement as Measured by Patient Global Impression of Change (PGI-C)
Measured: Baseline, Week 8
Change from Baseline in Worst Pain Intensity as Measured by NRS
Measured: Baseline, Week 8
Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Measured: Baseline, Week 8
Total Amount of Rescue Medication Used Daily During the Treatment Phase
Measured: Week 8
Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)
Measured: Baseline, Week 8
Mean Change from Baseline to Endpoint for the Roland-Morris Disability Questionnaire (RMDQ)
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start12 Aug 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641504
- Sponsor's protocol ID
- 27368
- Other IDs
- H0P-MC-BP07, H0P-MC-CPMP
- Acronym
- BP07
- Status last verified
- Nov 2026
- First submitted
- 8 Jun 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07641504
- Acronym / sponsor ID
- BP07 / 27368
- Conditions
- Chronic Pain, Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY4065967 | Experimental | Drug: LY4065967LY4065967 administered orally. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY4065967Administered orally. | Drug | LY4065967 |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Time frame: Baseline, Week 8
6 secondary outcomes
Change from Baseline in Mean Overall Improvement as Measured by Patient Global Impression of Change (PGI-C)
Time frame: Baseline, Week 8
Change from Baseline in Worst Pain Intensity as Measured by NRS
Time frame: Baseline, Week 8
Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Time frame: Baseline, Week 8
Total Amount of Rescue Medication Used Daily During the Treatment Phase
Time frame: Week 8
Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)
Time frame: Baseline, Week 8
Mean Change from Baseline to Endpoint for the Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Baseline, Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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) study director
Eli Lilly and Company
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY4065967 in people with Chronic Pain and Low Back Pain, run by Eli Lilly and Company at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.