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

NCT ID: NCT05986292
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Eli Lilly and Company
Conditions: Chronic Low-back Pain, Diabetic Neuropathic Pain, Osteoarthritis, Knee

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 10000 participants (Estimated).

What is being studied

Drug: LY3016859 ISA
Drug: LY3526318 ISA
Drug: LY3556050 ISA
Drug: LY3857210 ISA
Drug: LY4065967 ISA
Drug: Placebo
Drug: Placebo Oral

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility 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.

Study locations

64 study locations are listed.

Recruiting site status is explicitly provided for 64 locations; 36 are listed as Recruiting.

Countries: Puerto Rico, United States

Alabama, United States: 2
Arizona, United States: 4
California, United States: 4
Connecticut, United States: 1
Florida, United States: 19
Georgia, United States: 1
Idaho, United States: 1
Illinois, United States: 2
Kansas, United States: 1
Louisiana, United States: 1
Massachusetts, United States: 4
Michigan, United States: 1
Missouri, United States: 2
Nebraska, United States: 1
New York, United States: 1
North Carolina, United States: 1
North Dakota, United States: 1
Ohio, United States: 3
Oklahoma, United States: 1
Pennsylvania, United States: 2
South Carolina, United States: 1
Texas, United States: 5
Utah, United States: 1
Washington, United States: 2

Sample of listed locations

Ponce Medical School Foundation Inc. — Ponce, 00716, Puerto Rico — Recruiting
Central Research Associates — Birmingham, Alabama, 35205, United States — Recruiting
Arizona Research Center — Phoenix, Arizona, 85053, United States — Recruiting
Synexus Clinical Research US, Inc. — Phoenix, Arizona, 85020, United States — Recruiting
Desert Oasis Healthcare Medical Group — Palm Springs, California, 92262, United States — Recruiting
Artemis Institute for Clinical Research — Riverside, California, 92503, United States — Recruiting
Artemis Institute for Clinical Research — San Diego, California, 92123, United States — Recruiting
CMR of Greater New Haven, LLC — Hamden, Connecticut, 06517, United States — Recruiting
Bradenton Research Center, Inc. — Bradenton, Florida, 34205, United States — Recruiting
Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida, 32720, United States — Recruiting
K2 MEDICAL Research THE VILLAGES — Lady Lake, Florida, 32159, United States — Recruiting
K2 Medical Research ORLANDO — Maitland, Florida, 32751, United States — Recruiting
Merritt Island Medical Research, LLC — Merritt Island, Florida, 32952, United States — Recruiting
Flourish Research - Miami, LLC — Miami, Florida, 33135, United States — Recruiting
New Horizon Research Center — Miami, Florida, 33165, United States — Recruiting
Suncoast Clinical Research, Inc. — New Port Richey, Florida, 34652, United States — Recruiting
Renstar Medical Research — Ocala, Florida, 34470, United States — Recruiting
Precision Clinical Research — Sunrise, Florida, 33351, United States — Recruiting
Charter Research - Lady Lake — The Villages, Florida, 32162, United States — Recruiting
Conquest Research — Winter Park, Florida, 32789, United States — Recruiting
North Georgia Clinical Research — Woodstock, Georgia, 30189, United States — Recruiting
Northwestern University — Chicago, Illinois, 60611, United States — Recruiting
DelRicht Research — New Orleans, Louisiana, 70115, United States — Recruiting
Lucida Clinical Trials — New Bedford, Massachusetts, 02740, United States — Recruiting
MedVadis Research Corporation — Waltham, Massachusetts, 02451, United States — Recruiting

Study details

Start date: January 30, 2020
Primary completion date: April 1, 2027
Completion date: April 1, 2027
First posted: August 14, 2023

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05986292
Registry last updated: September 23, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT05986292 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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