A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain

Lilly

Status and phase: Completed; Phase 2

Conditions: Chronic Low-back Pain

Treatments: Drug: LY3857210; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05630196

H0P-MC-BP05 (Other Identifier)

18339

Details and patient eligibility

About

The main purpose of this study is to assess whether LY3857210 is safe and efficacious in relieving 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: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
• Have a history of daily pain for at least 12 weeks based on participant report or medical history.
• Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
• Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
• Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
• 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 history of low back pain as classified by the Quebec Task Force Category 1 through 3.
• Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening.
• Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion criteria

• Have a seizure disorder, history of seizure (other than remote history of childhood febrile seizure), or a condition that would place the participant at increased risk of seizure, such as head injury (for example, skull fracture, cerebral contusion, concussion, or trauma resulting in prolonged unconsciousness), intracranial neoplasm or hemorrhage.
• Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
• Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
• Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
• Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
• Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
• Have a positive human immunodeficiency virus (HIV) test result at screening.
• Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
• Have an intolerance to acetaminophen or paracetamol or any of its excipients.
• Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
• Have used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months prior to starting the washout period.
• Have history of or current compression fracture.
• Have had a recent major trauma (within 6 months of baseline).
• Are pregnant or breastfeeding.
• Have known history of gastric or duodenal ulcers.
• Have known history of inflammatory bowel disease (including ulcerative colitis or Crohn's disease).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups, including a placebo group

LY3857210

Experimental group

Description:

Participants received 45 milligrams (mg) of LY3857210 orally once daily for up to 8 weeks.

Treatment:

Drug: LY3857210

Placebo

Placebo Comparator group

Description:

Participants received placebo orally once daily for up to 8 weeks.

Treatment:

Drug: Placebo