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Osteoarthritis, KneePhase 2CPMPNCT05986292

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

A Phase 2 study testing LY3016859 ISA, LY3556050 ISA and LY3526318 ISA in people with Osteoarthritis, Knee and Diabetic Neuropathic Pain, run by Eli Lilly and Company at 64 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LY3016859 ISA, LY3556050 ISA and LY3526318 ISA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,000 participants
Where
64 sitesin 2 countries
Study dates
30 Jan 2020to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

64 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

64 sites in 2 countries

United States62 sites, 40 recruiting

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

    512-380-9925

    John Hudson

    Recruiting

  • VIN-Julie Schwartzbard

    Aventura, Florida, 33180

    Completed

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

    989-895-9100

    Jeffrey Potts

    Recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

    425-453-0404

    Arifulla Khan, MD

    Recruiting

  • Central Research Associates

    Birmingham, Alabama, 35205

    205-327-1077

    David DeAtkine

    Recruiting

  • Simon Williamson Clinic

    Birmingham, Alabama, 35211

    Completed

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

    617-477-4868

    Antonio Mendes

    Not yet recruiting

  • Bradenton Research Center, Inc.

    Bradenton, Florida, 34205

    9417080005

    Eric Folkens

    Recruiting

  • Synexus Clinical Research

    Chicago, Illinois, 60602

    Completed

  • Northwestern University

    Chicago, Illinois, 60611

    312-503-2315

    Thomas Schnitzer

    Recruiting

  • Synexus - Cincinnati

    Cincinnati, Ohio, 45236

    Completed

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

    6363875100

    Timothy Smith

    Recruiting

  • Aventiv Research Inc

    Columbus, Ohio, 43213

    Completed

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

    3054455637

    Jeffrey Rosen

    Not yet recruiting

  • Synexus

    Dallas, Texas, 75234

    Completed

  • Cedar Health Research

    Dallas, Texas, 75251

    Completed

  • META Medical Research Institute

    Dayton, Ohio, 45432

    Priyesh Mehta

    Recruiting

  • Accel Research Sites - DeLand Clinical Research Unit

    DeLand, Florida, 32720

    2057578212

    Bruce Rankin

    Recruiting

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

    814-693-0300

    Alan Kivitz

    Recruiting

  • Lillestol Research

    Fargo, North Dakota, 58104

    7012327705

    Michael Lillestol

    Recruiting

  • Re:Cognition Health - Fort Worth

    Fort Worth, Texas, 76104

    Terminated

  • Synexus Clinical Research - Glendale

    Glendale, Arizona, 85306

    Completed

  • PharmQuest

    Greensboro, North Carolina, 27408

    Completed

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517

    Jillian Reid

    Recruiting

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

    208-522-6005

    Kevin Prier

    Not yet recruiting

  • Irvine Clinical Research

    Irvine, California, 92614

    Completed

  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, Florida, 32159

    3525005252

    Craig Curtis

    Recruiting

  • K2 Medical Research ORLANDO

    Maitland, Florida, 32751

    407-500-5252

    Brandon Lenox

    Recruiting

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida, 32952

    David Kirk

    Recruiting

  • ActivMed Practices and Research

    Methuen, Massachusetts, 01844

    Completed

  • Flourish Research - Miami, LLC

    Miami, Florida, 33135

    305-631-6704

    Mark Kutner

    Recruiting

  • University of Miami Don Suffer Clinical Research Building

    Miami, Florida, 33136

    3052438555

    Danielle Horn

    Not yet recruiting

  • New Horizon Research Center

    Miami, Florida, 33165

    3052263933

    Lazaro Nunez

    Recruiting

  • SYNEXUS

    Murray, Utah, 84123

    Completed

  • Lucida Clinical Trials

    New Bedford, Massachusetts, 02740

    508-720-2015

    David Shih

    Recruiting

  • DelRicht Research

    New Orleans, Louisiana, 70115

    504-336-2667

    Patrick Dennis

    Recruiting

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

    (727) 849-4131

    Cathy Barnes

    Recruiting

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

    Completed

  • Renstar Medical Research

    Ocala, Florida, 34470

    3526295800

    David Oliver

    Recruiting

  • Synexus Clinical Research US, Inc.

    Omaha, Nebraska, 68144

    Completed

  • Synexus Clinical Research US, Inc.

    Orlando, Florida, 32806

    407-426-9299

    Beatriz Colon

    Not yet recruiting

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California, 92262

    760-320-9505

    Michael Jardula

    Recruiting

  • Synexus Clinical Research US, Inc.

    Phoenix, Arizona, 85020

    Shawn Searle

    Recruiting

  • Arizona Research Center

    Phoenix, Arizona, 85053

    602-863-6363

    Louise Taber MD

    Recruiting

  • Synexus Clinical Research - St. Petersburg

    Pinellas Park, Florida, 33781

    Completed

  • Martin E. Hale M.D., P.A.

    Plantation, Florida, 33317

    Completed

  • Rainier Clinical Research Center

    Renton, Washington, 98057

    425-251-1722

    Sheryl Marks

    Recruiting

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

    951-374-1190

    Jack Vu

    Recruiting

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

    585-288-0890

    Patrick Connors

    Recruiting

  • Synexus Clinical Research US, Inc.

    San Antonio, Texas, 78229

    Completed

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

    858-278-3647

    Stacey Layle

    Recruiting

  • Clinvest Research LLC

    Springfield, Missouri, 65807

    4178837889

    Ralph Duda

    Recruiting

  • Precision Clinical Research

    Sunrise, Florida, 33351

    Richard Linn

    Recruiting

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona, 85281

    Completed

  • Charter Research - Lady Lake

    The Villages, Florida, 32162

    Stephen Miller

    Recruiting

  • Synexus Clinical Research US, Inc.

    The Villages, Florida, 32162

    Completed

  • Cotton O'Neil Clinical Research Center - Central Office

    Topeka, Kansas, 66606

    Completed

  • DelRicht Research

    Tulsa, Oklahoma, 74133

    (504) 336-2667

    Melita Tate

    Recruiting

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

    6177441310

    David DiBenedetto

    Recruiting

  • Conquest Research

    Winter Park, Florida, 32789

    407-916-0060

    Anand Patel

    Recruiting

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

    6784945735

    Bram Wieskopf

    Recruiting

  • Clinical Research Center of Reading,LLC

    Wyomissing, Pennsylvania, 19610

    Completed

Other trials in United States

Puerto Rico2 sites, 1 recruiting

  • Ponce Medical School Foundation Inc.

    Ponce, 00716

    1-787-840-2505

    Elizabeth Barranco-Santana

    Recruiting

  • Latin Clinical Trial Center

    San Juan, 00909

    Completed

Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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.

Being tested
LY3016859 ISA, LY3556050 ISA, LY3526318 ISA, LY3857210 ISA, Placebo Oral
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3016859 ISADrug

    Administered intravenously (IV)

  • LY3556050 ISADrug

    Administered orally

  • LY3526318 ISADrug

    Administered orally

  • LY3857210 ISADrug

    Administered orally

  • Placebo OralDrug

    Placebo administered orally

  • PlaceboDrug

    Placebo administered IV

  • LY4065967 ISADrug

    Administered orally

Study groups in NCT05986292
Study groupRoleWhat they receive
LY3016859 Osteoarthritis ISAExperimentalParticipants are randomized to receive either active LY3016859 or matching placebo
Receives: Drug: LY3016859 ISA; Drug: Placebo
LY3016859 Diabetic Neuropathic Pain ISAExperimentalParticipants are randomized to receive either active LY3016859 or matching placebo
Receives: Drug: LY3016859 ISA; Drug: Placebo
LY3016859 Chronic Back Pain ISAExperimentalParticipants are randomized to receive either active LY3016859 or matching placebo
Receives: Drug: LY3016859 ISA; Drug: Placebo
LY3556050 Osteoarthritis ISAExperimentalParticipants are randomized to receive either active LY3556050 or matching placebo
Receives: Drug: LY3556050 ISA; Drug: Placebo Oral
LY3556050 Diabetic Neuropathic Pain ISAExperimentalParticipants are randomized to receive either active LY3556050 or matching placebo
Receives: Drug: LY3556050 ISA; Drug: Placebo Oral
LY3556050 Chronic Back Pain ISAExperimentalParticipants are randomized to receive either active LY3556050 or matching placebo
Receives: Drug: LY3556050 ISA; Drug: Placebo Oral
LY3526318 Osteoarthritis ISAExperimentalParticipants are randomized to receive either active LY3526318 or matching placebo
Receives: Drug: LY3526318 ISA; Drug: Placebo Oral
LY3526318 Diabetic Neuropathic Pain ISAExperimentalParticipants are randomized to receive either active LY3526318 or matching placebo
Receives: Drug: LY3526318 ISA; Drug: Placebo Oral
LY3526318 Chronic Back Pain ISAExperimentalParticipants are randomized to receive either active LY3526318 or matching placebo
Receives: Drug: LY3526318 ISA; Drug: Placebo Oral
LY3857210 Osteoarthritis ISAExperimentalParticipants are randomized to receive either active LY3857210 or matching placebo
Receives: Drug: LY3857210 ISA; Drug: Placebo Oral
LY3857210 Diabetic Neuropathic Pain ISAExperimentalParticipants are randomized to receive either active LY3857210 or matching placebo
Receives: Drug: LY3857210 ISA; Drug: Placebo Oral
LY3857210 Chronic Back Pain ISAExperimentalParticipants are randomized to receive either active LY3857210 or matching placebo
Receives: Drug: LY3857210 ISA; Drug: Placebo Oral
LY4065967 Chronic Low Back Pain ISAExperimentalParticipants are randomized to receive either active LY4065967 or matching placebo
Receives: Drug: Placebo Oral; Drug: LY4065967 ISA
LY4065967 Osteoarthritis ISAExperimentalParticipants are randomized to receive either active LY4065967 or matching placebo
Receives: Drug: Placebo Oral; Drug: LY4065967 ISA
LY4065967 Diabetic Neuropathic Pain ISAExperimentalParticipants are randomized to receive either active LY4065967 or matching placebo
Receives: Drug: Placebo Oral; Drug: LY4065967 ISA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Were Allocated to Each ISA

    Measured: Baseline, Up to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start30 Jan 2020
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05986292
Sponsor's protocol ID
17511
Other IDs
H0P-MC-CPMP
Acronym
CPMP
Status last verified
Sep 2026
First submitted
1 Aug 2023
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Knopp KL, Downing AM, Anthony L, Chaterjee S, Price K, Sparks J. An innovative phase 2 chronic pain master protocol design to assess novel mechanisms in multiple pain types. Pain Rep. 2024 Oct 16;9(6):e1203. doi: 10.1097/PR9.0000000000001203. eCollection 2024 Dec.

    PubMed 39430683

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3016859 ISA, LY3556050 ISA and LY3526318 ISA in people with Osteoarthritis, Knee and Diabetic Neuropathic Pain, run by Eli Lilly and Company at 64 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Were Allocated to Each ISA (time frame: Baseline, Up to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05986292, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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