Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain

NCT ID: NCT04707157

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2022-06-13

Brief Summary

This study is being done to test the safety and efficacy of the study drug LY3556050 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol (H0P-MC-CPMP) 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

600 Milligram (mg) LY3556050

Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.

Group Type: EXPERIMENTAL

LY3556050

Intervention Type: DRUG

given orally

Placebo

Participants received placebo BID every 12 hours for up to 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

given orally

Interventions

LY3556050

given orally

Intervention Type: DRUG

Placebo

given orally

Intervention Type: DRUG

Eligibility Criteria

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 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 ≤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 a 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.
• 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 history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
• Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.

• Have a history or presence of lactic acidosis.
• Have a history or presence of severe hepatic disease including cirrhosis.
• Have uncontrolled or unstable congestive heart failure.
• Are taking carbonic anhydrase inhibitors if also taking metformin.
• Have had a change in metformin therapy in the last 12 weeks.
• Have not maintained a stable dose of glucose-lowering agents other than metformin before randomization.
• Are pregnant or breastfeeding.
• Have fibromyalgia.

• 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- Chandler

Chandler, Arizona, United States

Synexus Clinical Research - Glendale

Glendale, Arizona, United States

Alliance for Multispecialty Research - Clinical Research Consortium

Tempe, 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

Hamden, Connecticut, United States

VIN-Julie Schwartzbard

Aventura, Florida, United States

Clinical Research of South Florida

Coral Gables, 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

Gold Coast Research

Plantation, Florida, United States

Synexus Clinical Research US, Inc - Orlando

The Villages, Florida, United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Synexus Clinical Research US, Inc.

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

NorthShore University HealthSystem

Skokie, Illinois, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Joslin Diabetes Center

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 Research LLC

Springfield, Missouri, United States

Synexus - Cincinnati

Cincinnati, Ohio, United States

META Medical Research Institute

Dayton, Ohio, United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

FutureSearch Trials

Austin, Texas, United States

Cedar Health Research

Dallas, Texas, United States

Synexus - US

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.lillytrialguide.com/en-US/trial/63OMIp14sbmhMbKx3Iuq9U

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain

Other Identifiers

H0P-MC-NP03

Identifier Type: OTHER

Identifier Source: secondary_id

17514

Identifier Type: -

Identifier Source: org_study_id