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

NCT ID: NCT05620576

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2023-08-01

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

45 mg LY3857210

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

Group Type: EXPERIMENTAL

LY3857210

Intervention Type: DRUG

Administered orally

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Interventions

LY3857210

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal 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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Synexus Clinical Research US, Inc.

Chandler, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

CMR of Greater New Haven, LLC

Hamden, Connecticut, United States

Accel Research Sites- Clinical Research Unit

DeLand, Florida, United States

Suncoast Research Group

Miami, Florida, United States

University of Miami Don Suffer Clinical Research Building

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Synexus Clinical Research US, Inc - Orlando

Orlando, Florida, United States

Synexus Clinical Research US, Inc.

Pinellas Park, Florida, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Northwestern University

Chicago, Illinois, United States

Boston Clinical Trials

Boston, Massachusetts, United States

ActivMed Practices and Research

Methuen, Massachusetts, United States

MedVadis Research Corporation

Waltham, Massachusetts, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

Clinvest Headlands Llc

Springfield, Missouri, United States

Lillestol Research

Fargo, North Dakota, United States

META Medical Research Institute

Dayton, Ohio, United States

Altoona center for clinical research

Duncansville, Pennsylvania, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Synexus Clinical Research - St. Petersburg

San Antonio, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Rainier Clinical Research Center

Renton, Washington, United States

Ponce Medical School Foundation Inc.

Ponce, , Puerto Rico

Latin Clinical Trial Center

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lilly.com/en-US/trial/368106

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

Other Identifiers

H0P-MC-NP05

Identifier Type: OTHER

Identifier Source: secondary_id

18340

Identifier Type: -

Identifier Source: org_study_id