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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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:

  • - 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 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 a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
  • - Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.
  • - Are taking metformin therapy.
  • - Are pregnant or breastfeeding.
  • - Have had any joint replacement such as knee of the lower extremity, such as hip, knee or ankle, in the past 6 months.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05620563
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: LY3857210

LY3857210 will be given orally

Placebo Comparator: Placebo

Placebo will be given orally

Interventions

Drug: - LY3852710

Administered orally

Drug: - Placebo

Administered orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Synexus Clinical Research US, Inc., Chandler, Arizona

Status

Recruiting

Address

Synexus Clinical Research US, Inc.

Chandler, Arizona, 85224

Arizona Research Center, Phoenix, Arizona

Status

Recruiting

Address

Arizona Research Center

Phoenix, Arizona, 85053

Artemis Institute for Clinical Research, Riverside, California

Status

Recruiting

Address

Artemis Institute for Clinical Research

Riverside, California, 92503

Artemis Institute for Clinical Research, San Diego, California

Status

Recruiting

Address

Artemis Institute for Clinical Research

San Diego, California, 92103

CMR of Greater New Haven, LLC, Hamden, Connecticut

Status

Recruiting

Address

CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517

DeLand, Florida

Status

Not yet recruiting

Address

Accel Research Sites- Clinical Research Unit

DeLand, Florida, 32720

Suncoast Research Group, Miami, Florida

Status

Not yet recruiting

Address

Suncoast Research Group

Miami, Florida, 33135

University of Miami, Miami, Florida

Status

Not yet recruiting

Address

University of Miami

Miami, Florida, 33136

New Horizon Research Center, Miami, Florida

Status

Not yet recruiting

Address

New Horizon Research Center

Miami, Florida, 33165

Renstar Medical Research, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research

Ocala, Florida, 34470

Orlando, Florida

Status

Recruiting

Address

Synexus Clinical Research US, Inc - Orlando

Orlando, Florida, 32806

Synexus Clinical Research US, Inc., Pinellas Park, Florida

Status

Recruiting

Address

Synexus Clinical Research US, Inc.

Pinellas Park, Florida, 33781

North Georgia Clinical Research, Woodstock, Georgia

Status

Recruiting

Address

North Georgia Clinical Research

Woodstock, Georgia, 30189

Rocky Mountain Clinical Research, Idaho Falls, Idaho

Status

Recruiting

Address

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Boston Clinical Trials, Boston, Massachusetts

Status

Not yet recruiting

Address

Boston Clinical Trials

Boston, Massachusetts, 02131

ActivMed Practices and Research, Methuen, Massachusetts

Status

Not yet recruiting

Address

ActivMed Practices and Research

Methuen, Massachusetts, 01844

MedVadis Research Corporation, Waltham, Massachusetts

Status

Recruiting

Address

MedVadis Research Corporation

Waltham, Massachusetts, 02451

Great Lakes Research Group, Inc., Bay City, Michigan

Status

Recruiting

Address

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706

StudyMetrix Research, Saint Peters, Missouri

Status

Recruiting

Address

StudyMetrix Research

Saint Peters, Missouri, 63303

Clinvest Research LLC, Springfield, Missouri

Status

Recruiting

Address

Clinvest Research LLC

Springfield, Missouri, 65807

Lillestol Research, Fargo, North Dakota

Status

Recruiting

Address

Lillestol Research

Fargo, North Dakota, 58104

META Medical Research Institute, Dayton, Ohio

Status

Recruiting

Address

META Medical Research Institute

Dayton, Ohio, 45432

Altoona Center For Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

FutureSearch Trials of Neurology, Austin, Texas

Status

Recruiting

Address

FutureSearch Trials of Neurology

Austin, Texas, 78731

Synexus Clinical Research US, Inc., San Antonio, Texas

Status

Recruiting

Address

Synexus Clinical Research US, Inc.

San Antonio, Texas, 78229

Northwest Clinical Research Center, Bellevue, Washington

Status

Recruiting

Address

Northwest Clinical Research Center

Bellevue, Washington, 98007

Rainier Clinical Research Center, Renton, Washington

Status

Recruiting

Address

Rainier Clinical Research Center

Renton, Washington, 98057

International Sites

Ponce Medical School Foundation Inc., Ponce, Puerto Rico

Status

Recruiting

Address

Ponce Medical School Foundation Inc.

Ponce, , 00716

Latin Clinical Trial Center, San Juan, Puerto Rico

Status

Not yet recruiting

Address

Latin Clinical Trial Center

San Juan, , 00909