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

June 19, 2026 updated by: Eli Lilly and Company

A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

10000

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Recruiting
        • Ponce Medical School Foundation Inc.
        • Principal Investigator:
          • Elizabeth Barranco-Santana
        • Contact:
          • Phone Number: 1-787-840-2505
      • San Juan, Puerto Rico, 00909
        • Completed
        • Latin Clinical Trial Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Central Research Associates
        • Principal Investigator:
          • David DeAtkine
        • Contact:
          • Phone Number: 205-327-1077
      • Birmingham, Alabama, United States, 35211
        • Completed
        • Simon Williamson Clinic
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Completed
        • Synexus Clinical Research - Glendale
      • Phoenix, Arizona, United States, 85053
        • Recruiting
        • Arizona Research Center
        • Contact:
          • Phone Number: 602-863-6363
        • Principal Investigator:
          • Louise Taber MD
      • Phoenix, Arizona, United States, 85020
        • Recruiting
        • Synexus Clinical Research US, Inc.
        • Principal Investigator:
          • Shawn Searle
      • Tempe, Arizona, United States, 85281
        • Completed
        • Alliance for Multispecialty Research, LLC
    • California
      • Irvine, California, United States, 92614
        • Completed
        • Irvine Clinical Research
      • Palm Springs, California, United States, 92262
        • Recruiting
        • Desert Oasis Healthcare Medical Group
        • Contact:
          • Phone Number: 760-320-9505
        • Principal Investigator:
          • Michael Jardula
      • Riverside, California, United States, 92503
        • Recruiting
        • Artemis Institute for Clinical Research
        • Contact:
          • Phone Number: 951-374-1190
        • Principal Investigator:
          • Jack Vu
      • San Diego, California, United States, 92123
        • Recruiting
        • Artemis Institute for Clinical Research
        • Contact:
          • Phone Number: 858-278-3647
        • Principal Investigator:
          • Stacey Layle
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Recruiting
        • CMR of Greater New Haven
        • Contact:
          • Phone Number: 203-419-4420
        • Principal Investigator:
          • Joseph Soufer
    • Florida
      • Aventura, Florida, United States, 33180
        • Completed
        • VIN-Julie Schwartzbard
      • Bradenton, Florida, United States, 34205
        • Recruiting
        • Bradenton Research Center, Inc.
        • Principal Investigator:
          • Eric Folkens
        • Contact:
          • Phone Number: 941-708-0005
      • Coral Gables, Florida, United States, 33134
        • Not yet recruiting
        • Clinical Research of South Florida
        • Contact:
          • Phone Number: 305-445-5637
        • Principal Investigator:
          • Jeffrey Rosen
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Accel Research Sites - DeLand Clinical Research Unit
        • Principal Investigator:
          • Bruce Rankin
        • Contact:
          • Phone Number: 205-757-8212
      • Lady Lake, Florida, United States, 32159
        • Recruiting
        • K2 Medical Research The Villages
        • Principal Investigator:
          • Craig Curtis
        • Contact:
          • Phone Number: 352-500-5252
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research ORLANDO
        • Contact:
          • Phone Number: 407-500-5252
        • Principal Investigator:
          • Brandon Lenox
      • Merritt Island, Florida, United States, 32952
        • Recruiting
        • Merritt Island Medical Research, LLC
        • Principal Investigator:
          • David Kirk
      • Miami, Florida, United States, 33165
        • Recruiting
        • New Horizon Research Center
        • Principal Investigator:
          • Lazaro Nunez
        • Contact:
          • Phone Number: 305-226-3933
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami Don Suffer Clinical Research Building
        • Contact:
          • Phone Number: 305-243-8555
        • Principal Investigator:
          • Danielle Horn
      • Miami, Florida, United States, 33135
        • Recruiting
        • Flourish Research - Miami, LLC
        • Principal Investigator:
          • Mark Kutner
        • Contact:
          • Phone Number: 305-631-6704
      • New Port Richey, Florida, United States, 34652
        • Recruiting
        • Suncoast Clinical Research, Inc.
        • Contact:
          • Phone Number: 727-849-4131
        • Principal Investigator:
          • Cathy Barnes
      • Ocala, Florida, United States, 34470
        • Recruiting
        • Renstar Medical Research
        • Contact:
          • Phone Number: 352-629-5800
        • Principal Investigator:
          • David Oliver
      • Orlando, Florida, United States, 32806
        • Not yet recruiting
        • Synexus Clinical Research US, Inc.
        • Contact:
          • Phone Number: 407-426-9299
        • Principal Investigator:
          • Beatriz Colon
      • Pinellas Park, Florida, United States, 33781
        • Completed
        • Synexus Clinical Research - St. Petersburg
      • Plantation, Florida, United States, 33317
        • Completed
        • Martin E. Hale M.D., P.A.
      • Sunrise, Florida, United States, 33351
        • Recruiting
        • Precision Clinical Research
        • Principal Investigator:
          • Richard Linn
      • The Villages, Florida, United States, 32162
        • Completed
        • Synexus Clinical Research US, Inc.
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research - Lady Lake
        • Principal Investigator:
          • Stephen Miller
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research
        • Principal Investigator:
          • Anand Patel
        • Contact:
          • Phone Number: 407-916-0060
    • Georgia
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • North Georgia Clinical Research
        • Contact:
          • Phone Number: 678-494-5735
        • Principal Investigator:
          • Bram Wieskopf
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Not yet recruiting
        • Rocky Mountain Clinical Research
        • Contact:
          • Phone Number: 208-522-6005
        • Principal Investigator:
          • Kevin Prier
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
          • Phone Number: 312-503-2315
        • Principal Investigator:
          • Thomas Schnitzer
      • Chicago, Illinois, United States, 60602
        • Completed
        • Synexus Clinical Research
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Completed
        • Cotton O'Neil Clinical Research Center - Central Office
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • DelRicht Research
        • Principal Investigator:
          • Patrick Dennis
        • Contact:
          • Phone Number: 504-336-2667
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Not yet recruiting
        • Boston Clinical Trials
        • Principal Investigator:
          • Antonio Mendes
        • Contact:
          • Phone Number: 617-477-4868
      • Methuen, Massachusetts, United States, 01844
        • Completed
        • ActivMed Practices and Research
      • New Bedford, Massachusetts, United States, 02740
        • Recruiting
        • Lucida Clinical Trials
        • Principal Investigator:
          • David Shih
        • Contact:
          • Phone Number: 508-720-2015
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • MedVadis Research Corporation
        • Contact:
          • Phone Number: 617-744-1310
        • Principal Investigator:
          • David DiBenedetto
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • Great Lakes Research Group, Inc.
        • Contact:
          • Phone Number: 989-895-9100
        • Principal Investigator:
          • Jeffrey Potts
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • Recruiting
        • StudyMetrix Research
        • Contact:
          • Phone Number: 636-387-5100
        • Principal Investigator:
          • Timothy Smith
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Clinvest Research LLC
        • Contact:
          • Phone Number: 417-883-7889
        • Principal Investigator:
          • Ralph Duda
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Completed
        • Synexus Clinical Research US, Inc.
    • New York
      • Rochester, New York, United States, 14609
        • Recruiting
        • Rochester Clinical Research, LLC
        • Contact:
          • Phone Number: 585-288-0890
        • Principal Investigator:
          • Patrick Connors
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Completed
        • PharmQuest
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Recruiting
        • Lillestol Research
        • Principal Investigator:
          • Michael Lillestol
        • Contact:
          • Phone Number: 701-232-7705
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Completed
        • Synexus - Cincinnati
      • Columbus, Ohio, United States, 43213
        • Completed
        • Aventiv Research Inc
      • Dayton, Ohio, United States, 45432
        • Recruiting
        • META Medical Research Institute
        • Principal Investigator:
          • Priyesh Mehta
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Recruiting
        • DelRicht Research
        • Principal Investigator:
          • Melita Tate
        • Contact:
          • Phone Number: 504-336-2667
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center for Clinical Research
        • Principal Investigator:
          • Alan Kivitz
        • Contact:
          • Phone Number: 814-693-0300
      • Wyomissing, Pennsylvania, United States, 19610
        • Completed
        • Clinical Research Center of Reading,LLC
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Completed
        • Coastal Carolina Research Center
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • FutureSearch Trials of Neurology
        • Contact:
          • Phone Number: 512-380-9925
        • Principal Investigator:
          • John Hudson
      • Dallas, Texas, United States, 75234
        • Completed
        • Synexus
      • Dallas, Texas, United States, 75251
        • Completed
        • Cedar Health Research
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Re:Cognition Health - Fort Worth
        • Contact:
          • Phone Number: 682-394-3500
        • Principal Investigator:
          • Claudia Perez
      • San Antonio, Texas, United States, 78229
        • Completed
        • Synexus Clinical Research US, Inc.
    • Utah
      • Murray, Utah, United States, 84123
        • Completed
        • Synexus
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:
          • Phone Number: 425-453-0404
        • Principal Investigator:
          • Arifulla Khan, MD
      • Renton, Washington, United States, 98057
        • Recruiting
        • Rainier Clinical Research Center
        • Principal Investigator:
          • Sheryl Marks
        • Contact:
          • Phone Number: 425-251-1722

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • have a visual analog scale (VAS) pain value >40 and <95 at screening and prerandomization screening.
  • have a history of daily pain for at least 12 weeks based on participant report or medical 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 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 rescue medication for the duration of the study

Exclusion Criteria:

  • have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia
  • 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 had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
  • have fibromyalgia
  • have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
  • have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental 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 2 years prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3016859 Osteoarthritis ISA
Participants are randomized to receive either active LY3016859 or matching placebo
Drug: LY3016859 ISA
Administered intravenously (IV)
Drug: Placebo
Placebo administered IV
Experimental: LY3016859 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3016859 or matching placebo
Drug: LY3016859 ISA
Administered intravenously (IV)
Drug: Placebo
Placebo administered IV
Experimental: LY3016859 Chronic Back Pain ISA
Participants are randomized to receive either active LY3016859 or matching placebo
Drug: LY3016859 ISA
Administered intravenously (IV)
Drug: Placebo
Placebo administered IV
Experimental: LY3556050 Osteoarthritis ISA
Participants are randomized to receive either active LY3556050 or matching placebo
Drug: LY3556050 ISA
Administered orally
Drug: Placebo Oral
Placebo administered orally
Experimental: LY3556050 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3556050 or matching placebo
Drug: LY3556050 ISA
Administered orally
Drug: Placebo Oral
Placebo administered orally
Experimental: LY3556050 Chronic Back Pain ISA
Participants are randomized to receive either active LY3556050 or matching placebo
Drug: LY3556050 ISA
Administered orally
Drug: Placebo Oral
Placebo administered orally
Experimental: LY3526318 Osteoarthritis ISA
Participants are randomized to receive either active LY3526318 or matching placebo
Drug: Placebo Oral
Placebo administered orally
Drug: LY3526318 ISA
Administered orally
Experimental: LY3526318 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3526318 or matching placebo
Drug: Placebo Oral
Placebo administered orally
Drug: LY3526318 ISA
Administered orally
Experimental: LY3526318 Chronic Back Pain ISA
Participants are randomized to receive either active LY3526318 or matching placebo
Drug: Placebo Oral
Placebo administered orally
Drug: LY3526318 ISA
Administered orally
Experimental: LY3857210 Osteoarthritis ISA
Participants are randomized to receive either active LY3857210 or matching placebo
Drug: Placebo Oral
Placebo administered orally
Drug: LY3857210 ISA
Administered orally
Experimental: LY3857210 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3857210 or matching placebo
Drug: Placebo Oral
Placebo administered orally
Drug: LY3857210 ISA
Administered orally
Experimental: LY3857210 Chronic Back Pain ISA
Participants are randomized to receive either active LY3857210 or matching placebo
Drug: Placebo Oral
Placebo administered orally
Drug: LY3857210 ISA
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Were Allocated to Each ISA
Time Frame: Baseline, Up to Week 8
Baseline, Up to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 30, 2020

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17511
  • H0P-MC-CPMP (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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