A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Last updated: August 22, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Chronic Pain

Pain (Pediatric)

Diabetic Neuropathy

Treatment

LY3526318 ISA

Placebo

Placebo Oral

Clinical Study ID

NCT05986292
17511
H0P-MC-CPMP
  • Ages > 18
  • All Genders

Study Summary

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • have a visual analog scale (VAS) pain value >40 and <95 at screening andprerandomization screening.

  • have a history of daily pain for at least 12 weeks based on participant report ormedical history

  • have a value of ≤30 on the pain catastrophizing scale

  • have a body mass index <40 kilogram/square meter (kg/m²) (inclusive)

  • are willing to maintain a consistent regimen of any ongoing nonpharmacologicpain-relieving therapies (for example, physical therapy) and will not start any newnonpharmacologic pain-relieving therapies during study participation.

  • are willing to discontinue all medications taken for chronic pain conditions, exceptrescue medication for the duration of the study

Exclusion

Exclusion Criteria:

  • have second- or third-degree atrioventricular (AV) heart block or AV dissociation orhistory of ventricular tachycardia

  • have had a procedure within the past 6 months intended to produce permanent sensoryloss in the target area of interest (for example, ablation techniques)

  • have surgery planned during the study for any reason, related or not to the diseasestate under evaluation.

  • have, in the judgment of the investigator, an acute, serious, or unstable medicalcondition or a history or presence of any other medical illness that would precludestudy participation.

  • have had cancer within 2 years of baseline, except for cutaneous basal cell orsquamous cell carcinoma resolved by excision.

  • have fibromyalgia

  • have substance use disorder as defined by the Diagnostic and Statistical Manual ofMental Disorders (5th edition; DSM-5; American Psychiatric Association)

  • have any clinically important abnormality at screening, as determined byinvestigator, in physical or neurological examination, vital signs,electrocardiogram (ECG), or clinical laboratory test results that could bedetrimental to the participant or could compromise the study.

  • have a positive human immunodeficiency virus (HIV) test result at screening

  • have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2years prior to screening.

Study Design

Total Participants: 10000
Treatment Group(s): 6
Primary Treatment: LY3526318 ISA
Phase: 2
Study Start date:
January 30, 2020
Estimated Completion Date:
April 30, 2027

Study Description

The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing.

Note: Results for all outcomes are posted in the intervention records. No need for duplication.

Connect with a study center

  • Ponce Medical School Foundation Inc.

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Ponce Medical School Foundation Inc.

    Ponce 4566880, 00716
    Puerto Rico

    Active - Recruiting

  • Latin Clinical Trial Center

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Latin Clinical Trial Center

    San Juan 4568127, 00909
    Puerto Rico

    Completed

  • Central Research Associates

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Simon Williamson Clinic

    Birmingham, Alabama 35211
    United States

    Completed

  • Central Research Associates

    Birmingham 4049979, Alabama 4829764 35205
    United States

    Site Not Available

  • Simon Williamson Clinic

    Birmingham 4049979, Alabama 4829764 35211
    United States

    Completed

  • Synexus Clinical Research - Glendale

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • Central Phoenix Medical Clinic

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona 85281
    United States

    Site Not Available

  • Synexus Clinical Research - Glendale

    Glendale 5295985, Arizona 5551752 85306
    United States

    Completed

  • Arizona Research Center

    Phoenix 5308655, Arizona 5551752 85053
    United States

    Active - Recruiting

  • Central Phoenix Medical Clinic

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Tempe 5317058, Arizona 5551752 85281
    United States

    Completed

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Site Not Available

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California 92262
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    Riverside, California 92503
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • Irvine Clinical Research

    Irvine 5359777, California 5332921 92614
    United States

    Completed

  • Desert Oasis Healthcare Medical Group

    Palm Springs 5380668, California 5332921 92262
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    Riverside 5387877, California 5332921 92503
    United States

    Active - Recruiting

  • Artemis Institute for Clinical Research

    San Diego 5391811, California 5332921 92103
    United States

    Active - Recruiting

  • CMR of Greater New Haven

    Hamden, Connecticut 06517
    United States

    Site Not Available

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut 06517
    United States

    Active - Recruiting

  • CMR of Greater New Haven

    Hamden 4835654, Connecticut 4831725 06517
    United States

    Active - Recruiting

  • VIN-Julie Schwartzbard

    Aventura, Florida 33180
    United States

    Site Not Available

  • Bradenton Research Center, Inc.

    Bradenton, Florida 34205
    United States

    Site Not Available

  • Clinical Research of South Florida

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Accel Research Sites - DeLand Clinical Research Unit

    DeLand, Florida 32720
    United States

    Site Not Available

  • Accel Research Sites- Clinical Research Unit

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Encore Research Group- Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • K2 Medical Research ORLANDO

    Maitland, Florida 32751
    United States

    Site Not Available

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida 32952
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Suncoast Research Group

    Miami, Florida 33135
    United States

    Active - Recruiting

  • University of Miami Don Suffer Clinical Research Building

    Miami, Florida 33136
    United States

    Site Not Available

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Orlando, Florida 32806
    United States

    Site Not Available

  • Synexus Clinical Research - St. Petersburg

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • Martin E. Hale M.D., P.A.

    Plantation, Florida 33317
    United States

    Site Not Available

  • Precision Clinical Research

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Charter Research - Lady Lake

    The Villages, Florida 32162
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    The Villages, Florida 32162
    United States

    Completed

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • VIN-Julie Schwartzbard

    Aventura 4146429, Florida 4155751 33180
    United States

    Completed

  • Bradenton Research Center, Inc.

    Bradenton 4148708, Florida 4155751 34205
    United States

    Site Not Available

  • Clinical Research of South Florida

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Site Not Available

  • Accel Research Sites - DeLand Clinical Research Unit

    DeLand 4152890, Florida 4155751 32720
    United States

    Active - Recruiting

  • K2 MEDICAL Research THE VILLAGES

    Lady Lake 4161118, Florida 4155751 32159
    United States

    Site Not Available

  • K2 Medical Research ORLANDO

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • Merritt Island Medical Research, LLC

    Merritt Island 4164092, Florida 4155751 32952
    United States

    Site Not Available

  • New Horizon Research Center

    Miami 4164138, Florida 4155751 33165
    United States

    Active - Recruiting

  • Suncoast Research Group

    Miami 4164138, Florida 4155751 33135
    United States

    Active - Recruiting

  • University of Miami Don Suffer Clinical Research Building

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Suncoast Clinical Research, Inc.

    New Port Richey 4165869, Florida 4155751 34652
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala 4166673, Florida 4155751 34470
    United States

    Active - Recruiting

  • Synexus Clinical Research US, Inc.

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • Synexus Clinical Research - St. Petersburg

    Pinellas Park 4168630, Florida 4155751 33781
    United States

    Completed

  • Martin E. Hale M.D., P.A.

    Plantation 4168782, Florida 4155751 33317
    United States

    Completed

  • Precision Clinical Research

    Sunrise 4174402, Florida 4155751 33351
    United States

    Site Not Available

  • Charter Research - Lady Lake

    The Villages 4175179, Florida 4155751 32162
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    The Villages 4175179, Florida 4155751 32162
    United States

    Completed

  • Conquest Research

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock 4231874, Georgia 4197000 30189
    United States

    Active - Recruiting

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Rocky Mountain Clinical Research

    Idaho Falls 5596475, Idaho 5596512 83404
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Physical Medicine and Rehabilitation

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Synexus Clinical Research

    Chicago, Illinois 60602
    United States

    Completed

  • Diabetes Research

    Skokie, Illinois 60077
    United States

    Site Not Available

  • NorthShore University Health System

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Northwestern University

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • Synexus Clinical Research

    Chicago 4887398, Illinois 4896861 60602
    United States

    Completed

  • Cotton O'Neil Clinical Research Center - Central Office

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Cotton O'Neil Clinical Research Center - Central Office

    Topeka 4280539, Kansas 4273857 66606
    United States

    Completed

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • DelRicht Research

    New Orleans 4335045, Louisiana 4331987 70115
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • ActivMed Practices and Research

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Lucida Clinical Trials

    New Bedford, Massachusetts 02740
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston 4930956, Massachusetts 6254926 02131
    United States

    Site Not Available

  • ActivMed Practices and Research

    Methuen 4943828, Massachusetts 6254926 01844
    United States

    Completed

  • Lucida Clinical Trials

    New Bedford 4945121, Massachusetts 6254926 02740
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham 4954380, Massachusetts 6254926 02451
    United States

    Active - Recruiting

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Great Lakes Research Group, Inc.

    Bay City 4985180, Michigan 5001836 48706
    United States

    Active - Recruiting

  • Research

    Saint Peters, Missouri 63303
    United States

    Active - Recruiting

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Site Not Available

  • StudyMetrix Research

    City of Saint Peters 4407237, Missouri 4398678 63303
    United States

    Active - Recruiting

  • Clinvest Research LLC

    Springfield 4409896, Missouri 4398678 65807
    United States

    Active - Recruiting

  • Synexus Clinical Research US, Inc.

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Omaha 5074472, Nebraska 5073708 68144
    United States

    Completed

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Site Not Available

  • Rochester Clinical Research, LLC

    Rochester 5134086, New York 5128638 14609
    United States

    Site Not Available

  • PharmQuest

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • PharmQuest Life Sciences, LLC

    Greensboro, North Carolina 27408
    United States

    Completed

  • PharmQuest

    Greensboro 4469146, North Carolina 4482348 27408
    United States

    Completed

  • Lillestol Research

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Lillestol Research

    Fargo 5059163, North Dakota 5690763 58104
    United States

    Active - Recruiting

  • Synexus - Cincinnati

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Rapid Medical Research

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Aventiv Research Inc

    Columbus, Ohio 43213
    United States

    Site Not Available

  • META Medical Research Institute

    Dayton, Ohio 45432
    United States

    Site Not Available

  • Synexus - Cincinnati

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Completed

  • Aventiv Research Inc

    Columbus 4509177, Ohio 5165418 43213
    United States

    Completed

  • META Medical Research Institute

    Dayton 4509884, Ohio 5165418 45432
    United States

    Active - Recruiting

  • DelRicht Research

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • DelRicht Research

    Tulsa 4553433, Oklahoma 4544379 74133
    United States

    Site Not Available

  • Altoona center for clinical research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Clinical Research Center of Reading,LLC

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville 5187508, Pennsylvania 6254927 16635
    United States

    Active - Recruiting

  • Clinical Research Center of Reading,LLC

    Wyomissing 5220248, Pennsylvania 6254927 19610
    United States

    Completed

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston 4589387, South Carolina 4597040 29405
    United States

    Completed

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Site Not Available

  • Cedar Health Research

    Dallas, Texas 75251
    United States

    Site Not Available

  • Synexus

    Dallas, Texas 75234
    United States

    Completed

  • Re:Cognition Health - Fort Worth

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin 4671654, Texas 4736286 78731
    United States

    Active - Recruiting

  • Cedar Health Research

    Dallas 4684888, Texas 4736286 75251
    United States

    Completed

  • Synexus

    Dallas 4684888, Texas 4736286 75234
    United States

    Completed

  • Re:Cognition Health - Fort Worth

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    San Antonio 4726206, Texas 4736286 78229
    United States

    Completed

  • SYNEXUS

    Murray, Utah 84123
    United States

    Site Not Available

  • SYNEXUS

    Murray 5778755, Utah 5549030 84123
    United States

    Completed

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue 5786882, Washington 5815135 98007
    United States

    Active - Recruiting

  • Rainier Clinical Research Center

    Renton 5808189, Washington 5815135 98057
    United States

    Active - Recruiting

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