Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain

H0P-MC-NP02 -

The purpose of this study is to test the safety and efficacy of study drug LY3526318 in participants with diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol (H0P-MC-CPMP) which is a protocol to accelerate the development of new treatments for chronic pain.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Diabetic Neuropathy
What the trial is testing?
LY3526318
Could I receive a Placebo?
Yes
Enrollment Goal
155
Trial Dates
Jan 26, 2022 - Oct 13, 2022
How long will I be in the trial?
Your participation could last about 8 weeks and may include up to 5 visits to the study center.
Trial Phase
II

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have daily pain for at least 12 weeks

  • Participants must have a body mass index of <40 kilograms per meter squared (kg/m²)

  • Participants must be willing to maintain any non-drug pain relieving therapies (for example, physical therapy) and not start any new non drug pain-relieving therapies during the study

  • Participants must be willing to stop all pain medications for diabetic nerve pain, except for rescue medication allowed in the study

  • Participants must have type 1 or type 2 diabetes and stable glycemic control

Participants Must Not:

  • Participants must not have surgery planned during the study for any reason

  • Participants must not have had cancer within 2 years, except for certain types of skin cancer (cutaneous basal cell or squamous cell carcinoma) surgically removed

  • Participants must not have an intolerance to acetaminophen or paracetamol

  • Participants must not have a history of alcohol or drug disorder within 2 years

  • Participants must not have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy

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