A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain

NCT ID: NCT05620563

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2023-06-12

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of LY3857210 in participants with Osteoarthritic Pain. 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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

45 mg LY3857210

Participants received 45 milligram (mg) LY3857210 orally once daily for up to 8 weeks.

Group Type: EXPERIMENTAL

LY3857210

Intervention Type: DRUG

Administered orally

Placebo

Participants received placebo orally once daily for up to 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Interventions

LY3857210

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• A seizure disorder, history of seizure (other than remote history of childhood febrile seizure), or a condition that would place the participant at increased risk of seizure
• 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 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 fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee.
• Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
• Have clinical signs and symptoms of active knee infection or crystal disease of the index knee.
• Have a history of infection in the index joint.
• Have a history of arthritis due to crystals (e.g., gout, pseudogout).
• Have pain or functional impairment due to ipsilateral hip osteoarthritis.
• Have had any joint replacement such as knee of the lower extremity, such as hip, knee or ankle, in the past 6 months.
• Are pregnant or breastfeeding.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Synexus Clinical Research US, Inc.

Chandler, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

CMR of Greater New Haven, LLC

Hamden, Connecticut, United States

Accel Research Sites- Clinical Research Unit

DeLand, Florida, United States

Suncoast Research Group

Miami, Florida, United States

University of Miami

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Synexus Clinical Research US, Inc - Orlando

Orlando, Florida, United States

Synexus Clinical Research US, Inc.

Pinellas Park, Florida, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Northwestern University

Chicago, Illinois, United States

Boston Clinical Trials

Boston, Massachusetts, United States

ActivMed Practices and Research

Methuen, Massachusetts, United States

MedVadis Research Corporation

Waltham, Massachusetts, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

Clinvest Research LLC

Springfield, Missouri, United States

Lillestol Research

Fargo, North Dakota, United States

META Medical Research Institute

Dayton, Ohio, United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Synexus Clinical Research US, Inc.

San Antonio, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Rainier Clinical Research Center

Renton, Washington, United States

Ponce Medical School Foundation Inc.

Ponce, , Puerto Rico

Latin Clinical Trial Center

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lilly.com/en-US/trial/368103

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain (OA05)

Other Identifiers

H0P-MC-OA05

Identifier Type: OTHER

Identifier Source: secondary_id

18338

Identifier Type: -

Identifier Source: org_study_id