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Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05177094
Collaborator
(none)
150
Enrollment
36
Locations
2
Arms
9.9
Anticipated Duration (Months)
4.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test the safety and efficacy of study drug LY3526318 in participants with diabetic peripheral neuropathic pain (DPNP). 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Actual Study Start Date :
Jan 26, 2022
Anticipated Primary Completion Date :
Nov 24, 2022
Anticipated Study Completion Date :
Nov 24, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3526318

Participants will be administered LY3526318 orally.

Drug: LY3526318
Administered orally
Placebo Comparator: Placebo

Participants will be administered placebo orally.

Drug: Placebo
Administered orally

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [Baseline, up to Week 8]

Secondary Outcome Measures

  1. Change from Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score [Baseline, up to Week 8]

  2. Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change [Baseline, up to Week 8]

  3. Change from Baseline for Worst Pain Intensity as Measured by NRS [Baseline, up to Week 8]

  4. Change from Baseline on the Visual Analog Scale (VAS) for Pain [Baseline, up to Week 8]

  5. Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) [Baseline, up to Week 8]

  6. Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) [Baseline, up to Week 8]

  7. Total Amount of Rescue Medication [Baseline, up to Week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  • Are at 18 years old or older at the time consent is signed.

  • 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 product 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 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.

  • 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.

  • Are pregnant or breastfeeding.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Synexus Clinical Research US, Inc. Chandler Arizona United States 85224
2 Synexus Clinical Research - Glendale Glendale Arizona United States 85306
3 Arizona Research Center Phoenix Arizona United States 85053
4 Alliance for Multispecialty Research, LLC Tempe Tempe Arizona United States 85281
5 Artemis Institute for Clinical Research Riverside California United States 92503
6 Artemis Institute for Clinical Research San Diego California United States 92103
7 CMR of Greater New Haven Hamden Connecticut United States 06517
8 VIN-Julie Schwartzbard Aventura Florida United States 33180
9 Suncoast Research Group Miami Florida United States 33135
10 University of Miami Don Suffer Clinical Research Building Miami Florida United States 33136
11 New Horizon Research Center Miami Florida United States 33165
12 Renstar Medical Research Ocala Florida United States 34470
13 Synexus Clinical Research US, Inc - Orlando Orlando Florida United States 32806
14 Synexus Clinical Research US, Inc. Pinellas Park Florida United States 33781
15 Synexus Clinical Research US, Inc - Orlando The Villages Florida United States 32162
16 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
17 Synexus Clinical Research US, Inc. Chicago Illinois United States 60602
18 Northwestern University Chicago Illinois United States 60611
19 NorthShore University HealthSystem Skokie Illinois United States 60077
20 Boston Clinical Trials Boston Massachusetts United States 02131
21 Joslin Diabetes Center Boston Massachusetts United States 02215
22 ActivMed Practices and Research Methuen Massachusetts United States 01844
23 MedVadis Research Corporation Waltham Massachusetts United States 02451
24 Great Lakes Research Group, Inc. Bay City Michigan United States 48706
25 StudyMetrix Research Saint Peters Missouri United States 63303
26 Clinvest Research LLC Springfield Missouri United States 65807
27 Synexus - Cincinnati Cincinnati Ohio United States 45236
28 META Medical Research Institute Dayton Ohio United States 45432
29 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
30 FutureSearch Trials Austin Texas United States 78731
31 Cedar Health Research Dallas Texas United States 75251
32 Synexus - US San Antonio Texas United States 78229
33 Northwest Clinical Research Center Bellevue Washington United States 98007
34 Rainier Clinical Research Center Renton Washington United States 98057
35 Ponce Medical School Foundation Inc. Ponce Puerto Rico 00716
36 Latin Clinical Trial Center San Juan Puerto Rico 00909

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05177094
Other Study ID Numbers:
  • 17597
  • H0P-MC-NP02
First Posted:
Jan 4, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neuralgia
Diabetic Neuropathies
Chronic Pain

Study Results

No Results Posted as of Aug 18, 2022