Recruiting

Phase 2

LY900028A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Sponsor:

Eli Lilly and Company

Code:

NCT05986292

Conditions

Osteoarthritis, Knee

Diabetic Neuropathic Pain

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LY3016859 ISA

LY3556050 ISA

LY3526318 ISA

LY3857210 ISA

Placebo Oral

Study Details

Brief 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.

Conditions

Osteoarthritis, Knee

Diabetic Neuropathic Pain

Chronic Low-back Pain

Study ID

NCT05986292

Start date

Jan 30, 2020

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: LY3016859 Osteoarthritis ISA

Participants are randomized to receive either active LY3016859 or matching placebo

experimental: LY3016859 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3016859 or matching placebo

experimental: LY3016859 Chronic Back Pain ISA

Participants are randomized to receive either active LY3016859 or matching placebo

experimental: LY3556050 Osteoarthritis ISA

Participants are randomized to receive either active LY3556050 or matching placebo

experimental: LY3556050 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3556050 or matching placebo

experimental: LY3556050 Chronic Back Pain ISA

Participants are randomized to receive either active LY3556050 or matching placebo

experimental: LY3526318 Osteoarthritis ISA

Participants are randomized to receive either active LY3526318 or matching placebo

experimental: LY3526318 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3526318 or matching placebo

experimental: LY3526318 Chronic Back Pain ISA

Participants are randomized to receive either active LY3526318 or matching placebo

experimental: LY3857210 Osteoarthritis ISA

Participants are randomized to receive either active LY3857210 or matching placebo

experimental: LY3857210 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3857210 or matching placebo

experimental: LY3857210 Chronic Back Pain ISA

Participants are randomized to receive either active LY3857210 or matching placebo

Interventions

LY3016859 ISA

Administered intravenously (IV)

LY3556050 ISA

Administered orally

LY3526318 ISA

Administered orally

LY3857210 ISA

Administered orally

Placebo Oral

Placebo administered orally

Placebo

Placebo administered IV

Primary outcome measure

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

Central Contacts and Locations

Central contacts

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

Locations

Central Research Associates

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

205-327-1077

Principal Investigator:

David DeAtkine

Synexus Clinical Research US, Inc.

Recruiting

Phoenix, Arizona, United States, 85020

Principal Investigator:

Shawn Searle

Arizona Research Center

Recruiting

Phoenix, Arizona, United States, 85053

Contacts

602-863-6363

Principal Investigator:

Louise Taber MD

Desert Oasis Healthcare Medical Group

Recruiting

Palm Springs, California, United States, 92262

Contacts

760-320-9505

Principal Investigator:

Michael Jardula

Artemis Institute for Clinical Research

Recruiting

Riverside, California, United States, 92503

Contacts

951-374-1190

Principal Investigator:

Jack Vu

Artemis Institute for Clinical Research

Recruiting

San Diego, California, United States, 92123

Contacts

858-278-3647

Principal Investigator:

Stacey Layle

CMR of Greater New Haven

Recruiting

Hamden, Connecticut, United States, 06517

Contacts

203-419-4420

Principal Investigator:

Joseph Soufer

Bradenton Research Center, Inc.

Recruiting

Bradenton, Florida, United States, 34205

Contacts

941-708-0005

Principal Investigator:

Eric Folkens

Accel Research Sites - DeLand Clinical Research Unit

Recruiting

DeLand, Florida, United States, 32720

Contacts

205-757-8212

Principal Investigator:

Bruce Rankin

K2 MEDICAL Research THE VILLAGES

Recruiting

Lady Lake, Florida, United States, 32159

Contacts

352-500-5252

Principal Investigator:

Craig Curtis

K2 Medical Research ORLANDO

Recruiting

Maitland, Florida, United States, 32751

Contacts

407-500-5252

Principal Investigator:

Brandon Lenox

Merritt Island Medical Research, LLC

Recruiting

Merritt Island, Florida, United States, 32952

Principal Investigator:

David Kirk

Flourish Research - Miami, LLC

Recruiting

Miami, Florida, United States, 33135

Contacts

305-631-6704

Principal Investigator:

Mark Kutner

New Horizon Research Center

Recruiting

Miami, Florida, United States, 33165

Contacts

305-226-3933

Principal Investigator:

Lazaro Nunez

Suncoast Clinical Research, Inc.

Recruiting

New Port Richey, Florida, United States, 34652

Contacts

727-849-4131

Principal Investigator:

Cathy Barnes

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34470

Contacts

352-629-5800

Principal Investigator:

David Oliver

Precision Clinical Research

Recruiting

Sunrise, Florida, United States, 33351

Principal Investigator:

Richard Linn

Charter Research - Lady Lake

Recruiting

The Villages, Florida, United States, 32162

Principal Investigator:

Stephen Miller

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

Contacts

407-916-0060

Principal Investigator:

Anand Patel

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Contacts

678-494-5735

Principal Investigator:

Bram Wieskopf

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

312-503-2315

Principal Investigator:

Thomas Schnitzer

DelRicht Research

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

504-336-2667

Principal Investigator:

Patrick Dennis

Lucida Clinical Trials

Recruiting

New Bedford, Massachusetts, United States, 02740

Contacts

508-720-2015

Principal Investigator:

David Shih

MedVadis Research Corporation

Recruiting

Waltham, Massachusetts, United States, 02451

Contacts

617-744-1310

Principal Investigator:

David DiBenedetto

Great Lakes Research Group, Inc.

Recruiting

Bay City, Michigan, United States, 48706

Contacts

989-895-9100

Principal Investigator:

Jeffrey Potts

StudyMetrix Research

Recruiting

City of Saint Peters, Missouri, United States, 63303

Contacts

636-387-5100

Principal Investigator:

Timothy Smith

Clinvest Research LLC

Recruiting

Springfield, Missouri, United States, 65807

Contacts

417-883-7889

Principal Investigator:

Ralph Duda

Rochester Clinical Research, LLC

Recruiting

Rochester, New York, United States, 14609

Contacts

585-288-0890

Principal Investigator:

Patrick Connors

Lillestol Research

Recruiting

Fargo, North Dakota, United States, 58104

Contacts

701-232-7705

Principal Investigator:

Michael Lillestol

META Medical Research Institute

Recruiting

Dayton, Ohio, United States, 45432

Principal Investigator:

Priyesh Mehta

DelRicht Research

Recruiting

Tulsa, Oklahoma, United States, 74133

Contacts

504-336-2667

Principal Investigator:

Melita Tate

Altoona Center For Clinical Research

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

814-693-0300

Principal Investigator:

Alan Kivitz

FutureSearch Trials of Neurology

Recruiting

Austin, Texas, United States, 78731

Contacts

512-380-9925

Principal Investigator:

John Hudson

Re:Cognition Health - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

682-394-3500

Principal Investigator:

Claudia Perez

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Contacts

425-453-0404

Principal Investigator:

Arifulla Khan, MD

Rainier Clinical Research Center

Recruiting

Renton, Washington, United States, 98057

Contacts

425-251-1722

Principal Investigator:

Sheryl Marks

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-06-23.