A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain (BP07)

Lilly

Status and phase: Begins enrollment this month; Phase 2

Conditions: Chronic Pain; Low Back Pain

Treatments: Drug: Placebo; Drug: LY4065967

Study type: Interventional

Funder types: Industry

Identifiers

NCT07641504

27368

H0P-MC-BP07 (Other Identifier)

H0P-MC-CPMP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

LY4065967

Experimental group

Description:

LY4065967 administered orally.

Treatment:

Drug: LY4065967

Placebo

Placebo Comparator group

Description:

Placebo administered orally.

Treatment:

Drug: Placebo