Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Osteoarthritis
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Osteoarthritis Pain
2 other identifiers
interventional
160
2 countries
30
Brief Summary
The purpose of this study is to test safety and efficacy of study drug LY3526318 in for the treatment of knee pain due to with osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2021
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2021
CompletedStudy Start
First participant enrolled
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
October 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2022
CompletedResults Posted
Study results publicly available
September 6, 2023
CompletedJuly 17, 2024
June 1, 2024
8 months
October 10, 2021
June 1, 2023
June 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Baseline, Week 4
Secondary Outcomes (19)
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Baseline, Week 8
Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale
Baseline, Week 4
Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale
Baseline, Week 8
Change From Baseline on the WOMAC® Stiffness Subscale
Baseline, Week 4
Change From Baseline on the WOMAC® Stiffness Subscale
Baseline, Week 8
- +14 more secondary outcomes
Study Arms (2)
LY3526318
EXPERIMENTALParticipants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.
Placebo
PLACEBO COMPARATORParticipants received placebo orally, once daily, for 8-weeks treatment period.
Interventions
Eligibility Criteria
You may qualify if:
- Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening.
- Have a history of daily pain for at least 12 weeks based on participant report or medical history.
- Have a body mass index \<40 kilograms per meter squared (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 for the duration of the study.
- Have presence of index knee pain for \>12 weeks at screening.
- Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee.
- Are men, or women able to abide by reproductive and contraceptive requirements.
You may not qualify if:
- 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 a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
- Have a positive human immunodeficiency virus (HIV) test result at screening.
- Are in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
- Have an intolerance to acetaminophen or paracetamol or any of its excipients.
- Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
- Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare.
- Have presence of surgical hardware or other foreign body in the index knee.
- Have an unstable index joint (such as a torn anterior cruciate ligament).
- Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to starting the washout period.
- Have chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Synexus- Chandler
Chandler, Arizona, 85224, United States
Synexus Clinical Research - Glendale
Glendale, Arizona, 85306, United States
Alliance for Multispecialty Research, LLC Tempe
Tempe, Arizona, 85281, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
CMR of Greater New Haven
Hamden, Connecticut, 06517, United States
VIN-Julie Schwartzbard
Aventura, Florida, 33180, United States
Suncoast Research Group
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Synexus Clinical Research US, Inc - Orlando
Orlando, Florida, 32806, United States
Synexus Clinical Research US, Inc.
Pinellas Park, Florida, 33781, United States
Synexus Clinical Research US, Inc - Orlando
The Villages, Florida, 32162, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Synexus Clinical Research US, Inc.
Chicago, Illinois, 60602, United States
Northwestern University
Chicago, Illinois, 60611, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65810, United States
Synexus - Cincinnati
Cincinnati, Ohio, 45236, United States
META Medical Research Institute
Dayton, Ohio, 45432, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Synexus - US
San Antonio, Texas, 78229, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2021
First Posted
October 18, 2021
Study Start
October 12, 2021
Primary Completion
June 6, 2022
Study Completion
June 6, 2022
Last Updated
July 17, 2024
Results First Posted
September 6, 2023
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.