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

NCT05620576 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 18340H0P-MC-NP05
• Study Type: interventional
• Target: 131
• Locations: 2 countries
• Sites: 30

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)

  The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

  Baseline, Week 8

Secondary Outcomes (7)

• Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score

  Baseline, Week 8

• Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGIC)

  Baseline, Week 8

• Change From Baseline for Worst Pain Intensity as Measured by NRS

  Baseline, Week 8

• Change From Baseline on the Visual Analog Scale (VAS) for Pain

  Baseline, Week 8

• Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep

  Baseline, Week 8

Study Arms (2)

45 mg LY3857210

EXPERIMENTAL

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

Drug: LY3857210

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LY3857210 DRUG

Administered orally

45 mg LY3857210

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (30)

Synexus Clinical Research US, Inc.

Chandler, Arizona, 85224, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517, United States

Location

Accel Research Sites- Clinical Research Unit

DeLand, Florida, 32720, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

University of Miami Don Suffer Clinical Research Building

Miami, Florida, 33136, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Synexus Clinical Research US, Inc - Orlando

Orlando, Florida, 32806, United States

Location

Synexus Clinical Research US, Inc.

Pinellas Park, Florida, 33781, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

ActivMed Practices and Research

Methuen, Massachusetts, 01844, United States

Location

MedVadis Research Corporation

Waltham, Massachusetts, 02451, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Headlands Llc

Springfield, Missouri, 65807, United States

Location

Lillestol Research

Fargo, North Dakota, 58104, United States

Location

META Medical Research Institute

Dayton, Ohio, 45432, United States

Location

Altoona center for clinical research

Duncansville, Pennsylvania, 16635, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Synexus Clinical Research - St. Petersburg

San Antonio, Texas, 78229, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Ponce Medical School Foundation Inc.

Ponce, 00716, Puerto Rico

Location

Latin Clinical Trial Center

San Juan, 00909, Puerto Rico

Location

Related Links

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 17, 2022
• Study Start: November 14, 2022
• Primary Completion: July 19, 2023
• Study Completion: August 1, 2023
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

PR (2); US (28)