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Not yet recruiting NCT07641504

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain

Phase II Interventional Chronic Pain Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY4065967, Placebo.
Who it may be relevant to
Registry conditions: Chronic Pain, Low Back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Puerto Rico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Chronic Low Back Pain

Overview

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of 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.

Interventions

  • Drug LY4065967
    Administered orally.
  • Drug Placebo
    Administered orally

Primary outcome measures

  • Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [Time frame: Baseline, Week 8]
Secondary outcome measures (6)
  • Change from Baseline in Mean Overall Improvement as Measured by Patient Global Impression of Change (PGI-C) [Time frame: Baseline, Week 8]
  • Change from Baseline in Worst Pain Intensity as Measured by NRS [Time frame: Baseline, Week 8]
  • Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) [Time frame: Baseline, Week 8]
  • Total Amount of Rescue Medication Used Daily During the Treatment Phase [Time frame: Week 8]
  • Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L) [Time frame: Baseline, Week 8]
  • Mean Change from Baseline to Endpoint for the Roland-Morris Disability Questionnaire (RMDQ) [Time frame: Baseline, Week 8]

Eligibility criteria

Inclusion criteria

  • 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 body mass index at screening of ≤40 kilograms per meter squared (kg/m²).
  • Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening

Exclusion criteria

  • Are pregnant or breastfeeding
  • Have used a therapeutic injection to the spine in the 3 months prior to screening
  • Are using a spinal cord stimulator or dorsal root ganglion stimulator
  • Have ongoing complex regional pain syndrome or other concurrent medical conditions that could interfere with the evaluation of CLBP
  • Have a history of major spinal deformity, such as spondylolisthesis, spondylolysis, scoliosis, or spina bifida, that causes instability to the spine
  • Have an abnormal blood pressure (BP) systolic BP is greater than 140 millimeters mercury (>140 mm Hg) and diastolic BP>90 mm Hg at screening • Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 36 centers
  • Central Research Associates — Birmingham
  • Synexus Clinical Research US, Inc. — Phoenix
  • Arizona Research Center — Phoenix
  • Desert Oasis Healthcare Medical Group — Palm Springs
  • Artemis Institute for Clinical Research — Riverside
  • Artemis Institute for Clinical Research — San Diego
  • CMR of Greater New Haven — Hamden
  • Bradenton Research Center, Inc. — Bradenton
  • … and 28 more centers
Puerto Rico · 1 center
  • Ponce Medical School Foundation Inc. — Ponce

Identifiers

NCT: NCT07641504 · 27368 · H0P-MC-BP07 · H0P-MC-CPMP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗