A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- LY4065967
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov