A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).

Lilly

Status and phase: Completed; Phase 2

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: LY3857210; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05620576

H0P-MC-NP05 (Other Identifier)

18340

Details and patient eligibility

About

This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain. 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: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a visual analog scale (VAS) pain value greater than or equal to (≥) 40 and less than (<) 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 pain medications taken for chronic pain conditions for the duration of the study.
• Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
• Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
• Have stable glycemic control as indicated by a glycated hemoglobin less than or equal to (≤) 11 at time of screening.
• Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion criteria

• 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 substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
• Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
• Have fibromyalgia.
• Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
• Have a positive human immunodeficiency virus (HIV) test result at screening.
• 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 a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
• Have known hereditary motor, sensory or autonomic neuropathies.
• 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.
• Are pregnant or breastfeeding.
• Have known or history of gastric or duodenal ulcers.
• Have known or 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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131 participants in 2 patient groups, including a placebo group

45 mg LY3857210

Experimental group

Description:

Participants received 45 milligram (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