A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain

Last updated: July 18, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

2

Condition

Chronic Pain

Treatment

LY3857210

Placebo

Clinical Study ID

NCT05630196
18339
H0P-MC-BP05
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to assess whether LY3857210 is safe and efficacious in relieving chronic low back pain (CLBP). 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.

Eligibility Criteria

Inclusion

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 ormedical history.

  • Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).

  • Are willing to maintain a consistent regimen of any ongoing nonpharmacologicpain-relieving therapies (for example, physical therapy) and will not start any newnonpharmacologic pain-relieving therapies during study participation.

  • Are willing to discontinue all medications taken for chronic pain conditions for theduration of the study.

  • Have a history of low back pain for at least 3 months located between the 12ththoracic vertebra and the lower gluteal folds, with or without radiation.

  • Have a history of low back pain as classified by the Quebec Task Force Category 1through 3.

  • Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less thanor equal to 10 at time of screening.

  • Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion

Exclusion Criteria:

  • Have a seizure disorder, history of seizure (other than remote history of childhoodfebrile seizure), or a condition that would place the participant at increased riskof seizure, such as head injury (for example, skull fracture, cerebral contusion,concussion, or trauma resulting in prolonged unconsciousness), intracranial neoplasmor hemorrhage.

  • Have had a procedure within the past 6 months intended to produce permanent sensoryloss in the target area of interest (for example, ablation techniques).

  • Have surgery planned during the study for any reason, related or not to the diseasestate under evaluation.

  • Have, in the judgment of the investigator, an acute, serious, or unstable medicalcondition or a history or presence of any other medical illness that would precludestudy participation.

  • Have had cancer within 2 years of baseline, except for cutaneous basal cell orsquamous cell carcinoma resolved by excision.

  • Have a substance use disorder as defined by the Diagnostic and Statistical Manual ofMental 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 tobe 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 2years prior to screening.

  • Have used a therapeutic injection (botulinum toxin or corticosteroids) in the 3months prior to starting the washout period.

  • Have history of or current compression fracture.

  • Have had a recent major trauma (within 6 months of baseline).

  • Are pregnant or breastfeeding.

  • Have known history of gastric or duodenal ulcers.

  • Have known history of inflammatory bowel disease (including ulcerative colitis orCrohn's disease).

Study Design

Total Participants: 138
Treatment Group(s): 2
Primary Treatment: LY3857210
Phase: 2
Study Start date:
December 08, 2022
Estimated Completion Date:
June 15, 2023

Connect with a study center

  • Ponce Medical School Foundation Inc.

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Latin Clinical Trial Center

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Synexus- Chandler

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    Riverside, California 92503
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut 06517
    United States

    Site Not Available

  • Accel Research Sites- Clinical Research Unit

    DeLand, Florida 32720
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • Suncoast Research Group

    Miami, Florida 33135
    United States

    Site Not Available

  • University of Miami Don Suffer Clinical Research Building

    Miami, Florida 33136
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • Synexus - US

    Orlando, Florida 32806
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • ActivMed Practices and Research

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Lillestol Research LLC

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • META Medical Research Institute

    Dayton, Ohio 45432
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • FutureSearch Trials

    Austin, Texas 78731
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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