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NCT Number: NCT07641504

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

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Key information

Conditions

Chronic Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ponce Medical School Foundation Inc., Ponce, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4065967

Drug

Administered orally.

Placebo

Drug

Administered orally

Primary outcomes

  1. Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)

    Time frame: Baseline, Week 8

Secondary outcomes

  1. Change from Baseline in Mean Overall Improvement as Measured by Patient Global Impression of Change (PGI-C)

    Time frame: Baseline, Week 8

  2. Change from Baseline in Worst Pain Intensity as Measured by NRS

    Time frame: Baseline, Week 8

  3. Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)

    Time frame: Baseline, Week 8

  4. Total Amount of Rescue Medication Used Daily During the Treatment Phase

    Time frame: Week 8

  5. Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)

    Time frame: Baseline, Week 8

  6. Mean Change from Baseline to Endpoint for the Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: Baseline, Week 8

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Chronic Low Back Pain

Acronym: BP07

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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