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.
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
- Conditions the study is for
- Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain
- What is being tested?
- LY3016859 ISA, LY3556050 ISA and LY3526318 ISA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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
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- 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
Physicians interested in becoming principal investigators please contact contact
64 sites in 2 countries
United States62 sites, 40 recruiting
- Recruiting
FutureSearch Trials of Neurology
Austin, Texas, 78731
512-380-9925
John Hudson
- Completed
VIN-Julie Schwartzbard
Aventura, Florida, 33180
- Recruiting
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
- Completed
Simon Williamson Clinic
Birmingham, Alabama, 35211
- Not yet recruiting
Boston Clinical Trials
Boston, Massachusetts, 02131
617-477-4868
Antonio Mendes
- Recruiting
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
9417080005
Eric Folkens
- Completed
Synexus Clinical Research
Chicago, Illinois, 60602
- Recruiting
Northwestern University
Chicago, Illinois, 60611
312-503-2315
Thomas Schnitzer
- Completed
Synexus - Cincinnati
Cincinnati, Ohio, 45236
- Recruiting
StudyMetrix Research
City of Saint Peters, Missouri, 63303
6363875100
Timothy Smith
- Completed
Aventiv Research Inc
Columbus, Ohio, 43213
- Not yet recruiting
Clinical Research of South Florida
Coral Gables, Florida, 33134
3054455637
Jeffrey Rosen
- Completed
Synexus
Dallas, Texas, 75234
- Completed
Cedar Health Research
Dallas, Texas, 75251
- Recruiting
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
- Terminated
Re:Cognition Health - Fort Worth
Fort Worth, Texas, 76104
- Completed
Synexus Clinical Research - Glendale
Glendale, Arizona, 85306
- Completed
PharmQuest
Greensboro, North Carolina, 27408
- Recruiting
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517
Jillian Reid
- Not yet recruiting
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
208-522-6005
Kevin Prier
- Completed
Irvine Clinical Research
Irvine, California, 92614
- Recruiting
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
- Completed
ActivMed Practices and Research
Methuen, Massachusetts, 01844
- Recruiting
Flourish Research - Miami, LLC
Miami, Florida, 33135
305-631-6704
Mark Kutner
- Not yet recruiting
University of Miami Don Suffer Clinical Research Building
Miami, Florida, 33136
3052438555
Danielle Horn
- Recruiting
New Horizon Research Center
Miami, Florida, 33165
3052263933
Lazaro Nunez
- Completed
SYNEXUS
Murray, Utah, 84123
- Recruiting
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
- Completed
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
- Recruiting
Renstar Medical Research
Ocala, Florida, 34470
3526295800
David Oliver
- Completed
Synexus Clinical Research US, Inc.
Omaha, Nebraska, 68144
- Not yet recruiting
Synexus Clinical Research US, Inc.
Orlando, Florida, 32806
407-426-9299
Beatriz Colon
- 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
- Completed
Synexus Clinical Research - St. Petersburg
Pinellas Park, Florida, 33781
- Completed
Martin E. Hale M.D., P.A.
Plantation, Florida, 33317
- Recruiting
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
- Completed
Synexus Clinical Research US, Inc.
San Antonio, Texas, 78229
- Recruiting
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
- Completed
Alliance for Multispecialty Research, LLC
Tempe, Arizona, 85281
- Recruiting
Charter Research - Lady Lake
The Villages, Florida, 32162
Stephen Miller
- Completed
Synexus Clinical Research US, Inc.
The Villages, Florida, 32162
- Completed
Cotton O'Neil Clinical Research Center - Central Office
Topeka, Kansas, 66606
- Recruiting
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
- Completed
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, 19610
Puerto Rico2 sites, 1 recruiting
- Recruiting
Ponce Medical School Foundation Inc.
Ponce, 00716
1-787-840-2505
Elizabeth Barranco-Santana
- Completed
Latin Clinical Trial Center
San Juan, 00909
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 group | Role | What they receive |
|---|---|---|
| LY3016859 Osteoarthritis ISA | Experimental | Participants are randomized to receive either active LY3016859 or matching placebo Receives: Drug: LY3016859 ISA; Drug: Placebo |
| LY3016859 Diabetic Neuropathic Pain ISA | Experimental | Participants are randomized to receive either active LY3016859 or matching placebo Receives: Drug: LY3016859 ISA; Drug: Placebo |
| LY3016859 Chronic Back Pain ISA | Experimental | Participants are randomized to receive either active LY3016859 or matching placebo Receives: Drug: LY3016859 ISA; Drug: Placebo |
| LY3556050 Osteoarthritis ISA | Experimental | Participants are randomized to receive either active LY3556050 or matching placebo Receives: Drug: LY3556050 ISA; Drug: Placebo Oral |
| LY3556050 Diabetic Neuropathic Pain ISA | Experimental | Participants are randomized to receive either active LY3556050 or matching placebo Receives: Drug: LY3556050 ISA; Drug: Placebo Oral |
| LY3556050 Chronic Back Pain ISA | Experimental | Participants are randomized to receive either active LY3556050 or matching placebo Receives: Drug: LY3556050 ISA; Drug: Placebo Oral |
| LY3526318 Osteoarthritis ISA | Experimental | Participants are randomized to receive either active LY3526318 or matching placebo Receives: Drug: LY3526318 ISA; Drug: Placebo Oral |
| LY3526318 Diabetic Neuropathic Pain ISA | Experimental | Participants are randomized to receive either active LY3526318 or matching placebo Receives: Drug: LY3526318 ISA; Drug: Placebo Oral |
| LY3526318 Chronic Back Pain ISA | Experimental | Participants are randomized to receive either active LY3526318 or matching placebo Receives: Drug: LY3526318 ISA; Drug: Placebo Oral |
| LY3857210 Osteoarthritis ISA | Experimental | Participants are randomized to receive either active LY3857210 or matching placebo Receives: Drug: LY3857210 ISA; Drug: Placebo Oral |
| LY3857210 Diabetic Neuropathic Pain ISA | Experimental | Participants are randomized to receive either active LY3857210 or matching placebo Receives: Drug: LY3857210 ISA; Drug: Placebo Oral |
| LY3857210 Chronic Back Pain ISA | Experimental | Participants are randomized to receive either active LY3857210 or matching placebo Receives: Drug: LY3857210 ISA; Drug: Placebo Oral |
| LY4065967 Chronic Low Back Pain ISA | Experimental | Participants are randomized to receive either active LY4065967 or matching placebo Receives: Drug: Placebo Oral; Drug: LY4065967 ISA |
| LY4065967 Osteoarthritis ISA | Experimental | Participants are randomized to receive either active LY4065967 or matching placebo Receives: Drug: Placebo Oral; Drug: LY4065967 ISA |
| LY4065967 Diabetic Neuropathic Pain ISA | Experimental | Participants 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.
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.
- First posted14 Aug 2023
- Study start30 Jan 2020
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
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