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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05620576
Collaborator
(none)
125
Enrollment
30
Locations
2
Arms
11.5
Anticipated Duration (Months)
4.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being done to test the safety and efficacy of the study drug LY3852710 for the treatment of diabetic peripheral neuropathic pain.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 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 :
Nov 14, 2022
Anticipated Primary Completion Date :
Oct 16, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3852710

Participants will be given LY3852710 orally.

Drug: LY3852710
Administered orally
Placebo Comparator: Placebo

Participants will be given 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]

Eligibility Criteria

Criteria

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

  • Males and females may participate in this trial.

  • No male contraception is required except in compliance with specific local government study requirements.

  • Women of child bearing potential (WOCBP) and women not of child bearing potential (WNOCBP) may participate in this trial.

  • Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  • 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.

  • Have an eGFR of <30 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at Day 1 or Day 2.

  • evidence of Hepatitis B virus or Hepatitis C virus.

  • Women who 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 Arizona Research Center Phoenix Arizona United States 85053
3 Artemis Institute for Clinical Research Riverside California United States 92503
4 Artemis Institute for Clinical Research San Diego California United States 92103
5 CMR of Greater New Haven, LLC Hamden Connecticut United States 06517
6 Accel Research Sites- Clinical Research Unit DeLand Florida United States 32720
7 Suncoast Research Group Miami Florida United States 33135
8 University of Miami Don Suffer Clinical Research Building Miami Florida United States 33136
9 New Horizon Research Center Miami Florida United States 33165
10 Renstar Medical Research Ocala Florida United States 34470
11 Synexus Clinical Research US, Inc - Orlando Orlando Florida United States 32806
12 Synexus Clinical Research US, Inc. Pinellas Park Florida United States 33781
13 North Georgia Clinical Research Woodstock Georgia United States 30189
14 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
15 Northwestern University Chicago Illinois United States 60611
16 Boston Clinical Trials Boston Massachusetts United States 02131
17 ActivMed Practices and Research Methuen Massachusetts United States 01844
18 MedVadis Research Corporation Waltham Massachusetts United States 02451
19 Great Lakes Research Group, Inc. Bay City Michigan United States 48706
20 StudyMetrix Research Saint Peters Missouri United States 63303
21 Clinvest Research LLC Springfield Missouri United States 65807
22 Lillestol Research Fargo North Dakota United States 58104
23 META Medical Research Institute Dayton Ohio United States 45432
24 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
25 FutureSearch Trials of Neurology Austin Texas United States 78731
26 Synexus Clinical Research US, Inc. San Antonio Texas United States 78229
27 Northwest Clinical Research Center Bellevue Washington United States 98007
28 Rainier Clinical Research Center Renton Washington United States 98057
29 Ponce Medical School Foundation Inc. Ponce Puerto Rico 00716
30 Latin Clinical Trial Center San Juan Puerto Rico 00909

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05620576
Other Study ID Numbers:
  • 18340
  • H0P-MC-NP05
First Posted:
Nov 17, 2022
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
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
Peripheral Nervous System Diseases
Diabetic Neuropathies
Chronic Pain

Study Results

No Results Posted as of Jan 19, 2023