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RecruitingPhase 2

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

Eli Lilly and Company · NCT05986292

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
10000
US sites recruiting
35
Study start
January 30, 2020
Record last updated
September 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: LY3016859 ISA; LY3556050 ISA; LY3526318 ISA; LY3857210 ISA; Placebo Oral; Placebo; LY4065967 ISA

Conditions: Osteoarthritis, Knee; Diabetic Neuropathic Pain; Chronic Low-back Pain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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
  • are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements 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 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.

Recruiting US locations

  • Central Research Associates

    Birmingham, AL 35205

    Site contact: 205-327-1077

  • Synexus Clinical Research US, Inc.

    Phoenix, AZ 85020

    Site contact: Shawn Searle

  • Arizona Research Center

    Phoenix, AZ 85053

    Site contact: 602-863-6363

  • Desert Oasis Healthcare Medical Group

    Palm Springs, CA 92262

    Site contact: 760-320-9505

  • Artemis Institute for Clinical Research

    Riverside, CA 92503

    Site contact: 951-374-1190

  • Artemis Institute for Clinical Research

    San Diego, CA 92123

    Site contact: 858-278-3647

  • CMR of Greater New Haven, LLC

    Hamden, CT 06517

    Site contact: Jillian Reid

  • Bradenton Research Center, Inc.

    Bradenton, FL 34205

    Site contact: 9417080005

  • Accel Research Sites - DeLand Clinical Research Unit

    DeLand, FL 32720

    Site contact: 2057578212

  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, FL 32159

    Site contact: 3525005252

  • K2 Medical Research ORLANDO

    Maitland, FL 32751

    Site contact: 407-500-5252

  • Merritt Island Medical Research, LLC

    Merritt Island, FL 32952

    Site contact: David Kirk

  • Flourish Research - Miami, LLC

    Miami, FL 33135

    Site contact: 305-631-6704

  • New Horizon Research Center

    Miami, FL 33165

    Site contact: 3052263933

  • Suncoast Clinical Research, Inc.

    New Port Richey, FL 34652

    Site contact: (727) 849-4131

  • Renstar Medical Research

    Ocala, FL 34470

    Site contact: 3526295800

  • Precision Clinical Research

    Sunrise, FL 33351

    Site contact: Richard Linn

  • Charter Research - Lady Lake

    The Villages, FL 32162

    Site contact: Stephen Miller

  • Conquest Research

    Winter Park, FL 32789

    Site contact: 407-916-0060

  • North Georgia Clinical Research

    Woodstock, GA 30189

    Site contact: 6784945735

  • Northwestern University

    Chicago, IL 60611

    Site contact: 312-503-2315

  • DelRicht Research

    New Orleans, LA 70115

    Site contact: 504-336-2667

  • Lucida Clinical Trials

    New Bedford, MA 02740

    Site contact: 508-720-2015

  • MedVadis Research Corporation

    Waltham, MA 02451

    Site contact: 6177441310

  • Great Lakes Research Group, Inc.

    Bay City, MI 48706

    Site contact: 989-895-9100

  • StudyMetrix Research

    City of Saint Peters, MO 63303

    Site contact: 6363875100

  • Clinvest Research LLC

    Springfield, MO 65807

    Site contact: 4178837889

  • Rochester Clinical Research, LLC

    Rochester, NY 14609

    Site contact: 585-288-0890

  • Lillestol Research

    Fargo, ND 58104

    Site contact: 7012327705

  • META Medical Research Institute

    Dayton, OH 45432

    Site contact: Priyesh Mehta

  • DelRicht Research

    Tulsa, OK 74133

    Site contact: (504) 336-2667

  • Altoona Center For Clinical Research

    Duncansville, PA 16635

    Site contact: 814-693-0300

  • FutureSearch Trials of Neurology

    Austin, TX 78731

    Site contact: 512-380-9925

  • Northwest Clinical Research Center

    Bellevue, WA 98007

    Site contact: 425-453-0404

  • Rainier Clinical Research Center

    Renton, WA 98057

    Site contact: 425-251-1722

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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A Master Protocol Study (LY900028) of Multiple… (NCT05986292) | Bored Studies