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Phase 2 N=138 Randomized Double-blind Treatment

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

Chronic Low-back Pain

Enrolled (actual)
138
Serious AEs
1.5%
Results posted
Aug 2024
Primary outcome: Primary: Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) — -1.24; -1.63 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
LY3857210 (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Eli Lilly and Company
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
-1.24; -1.63
SECONDARY
Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)
-2.90; -4.06
SECONDARY
Mean Overall Improvement as Measured by Patient's Global Impression of Change
3.10; 2.88
SECONDARY
Change From Baseline for Worst Pain Intensity as Measured by NRS
-1.37; -1.89
SECONDARY
Change From Baseline on the Visual Analog Scale (VAS) for Pain
-17.78; -21.97
SECONDARY
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep
-0.06; 0.29
SECONDARY
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
203.84; 214.94
SECONDARY
Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)
0.05; 0.06

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 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 a history of low back pain for at least 3 months located between the 12th thoracic 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 1 through 3.
  • Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening.
  • Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria

  • Have 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, such as head injury (for example, skull fracture, cerebral contusion, concussion, or trauma resulting in prolonged unconsciousness), intracranial neoplasm or hemorrhage.
  • 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.
  • Have used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months 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 or Crohn's disease).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05630196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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