COMPLETED

A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain (DPNP). The study will lasts approximately 24 weeks, across 3 study periods.

Official Title

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

Quick Facts

Study Start:2023-10-05

Study Completion:2025-06-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06074562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening. * Have a stable glycemic control on stable diabetes treatment regimen for at least 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 for T1D and HbA1c ≤11 for participants with T2D at time of screening. * Have a history of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history. * Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening. * Have presence of diabetic peripheral neuropathy of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument * 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, except allowed concomitant pain medication permitted per protocol, for the duration of the study * Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive). * Are men, or women able to abide by reproductive and contraceptive requirements.	* History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP. * 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 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 in the judgement 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 positive HIV test result at screening. * Have a surgery planned during the study for any reason. * Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)

Inclusion Criteria

Exclusion Criteria

* Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening.
* Have a stable glycemic control on stable diabetes treatment regimen for at least 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 for T1D and HbA1c ≤11 for participants with T2D at time of screening.
* Have a history of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history.
* Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening.
* Have presence of diabetic peripheral neuropathy of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument
* 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, except allowed concomitant pain medication permitted per protocol, for the duration of the study
* Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive).
* Are men, or women able to abide by reproductive and contraceptive requirements.

* History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP.
* 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 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 in the judgement 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 positive HIV test result at screening.
* Have a surgery planned during the study for any reason.
* Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)

Contacts and Locations

Principal Investigator

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)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

Chandler, Arizona, 85225

United States

Headlands Research - Scottsdale

Scottsdale, Arizona, 85260

United States

Orange Grove Family Practice

Tucson, Arizona, 85741

United States

Preferred Research Partners

Little Rock, Arkansas, 72211

United States

Hope Clinical Research, Inc.

Canoga Park, California, 91303

United States

Valley Clinical Trials, Inc.

Northridge, California, 91325

United States

Northern California Research - Sacramento

Sacramento, California, 95821

United States

CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517

United States

Suncoast Research Group

Miami, Florida, 33135

United States

New Horizon Research Center

Miami, Florida, 33165

United States

Northwestern University

Chicago, Illinois, 60611

United States

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67205

United States

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, 40509

United States

Care Access - Lake Charles

Lake Charles, Louisiana, 70601

United States

MedVadis Research Corporation

Waltham, Massachusetts, 02451

United States

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157

United States

Alliance for Multispecialty Research, LLC

Kansas City, Missouri, 64114

United States

StudyMetrix Research

Saint Peters, Missouri, 63303

United States

Clinvest Research LLC

Springfield, Missouri, 65807

United States

Las Vegas Medical Research

Las Vegas, Nevada, 89128

United States

UniMed Center

East Brunswick, New Jersey, 08816

United States

North Suffolk Neurology

Port Jefferson Station, New York, 11776

United States

Lucas Research - Hickory

Hickory, North Carolina, 28601

United States

Lucas Research, Inc

Morehead City, North Carolina, 28557

United States

Velocity Clinical Research, Medford

Medford, Oregon, 97504

United States

Tristar Clinical Investigations

Philadelphia, Pennsylvania, 19114

United States

Suburban Research Associates

West Chester, Pennsylvania, 19380

United States

New Phase Research and Development

Knoxville, Tennessee, 37909

United States

FutureSearch Trials of Neurology

Austin, Texas, 78731

United States

Juno Research

Houston, Texas, 77040

United States

Consano Clinical Research, LLC

Shavano Park, Texas, 78231

United States

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088

United States

Northwest Clinical Research Center

Bellevue, Washington, 98007

United States

Rainier Clinical Research Center

Renton, Washington, 98057

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-05

Study Completion Date2025-06-11

Study Record Updates

Study Start Date2023-10-05

Study Completion Date2025-06-11

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Peripheral Neuropathy