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

ConditionsChronic PainLow Back Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4065967

    Drug

    Administered orally.

  • Placebo

    Drug

    Administered orally

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: LY4065967Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)

Time frame
Baseline, Week 8

Secondary outcomes

1

Change from Baseline in Mean Overall Improvement as Measured by Patient Global Impression of Change (PGI-C)

Time frame
Baseline, Week 8
2

Change from Baseline in Worst Pain Intensity as Measured by NRS

Time frame
Baseline, Week 8
3

Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)

Time frame
Baseline, Week 8
4

Total Amount of Rescue Medication Used Daily During the Treatment Phase

Time frame
Week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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