A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain (NP07)

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: Placebo; Drug: LY4065967

Study type: Interventional

Funder types: Industry

Identifiers

NCT07285018

H0P-MC-NP07 (Other Identifier)

27370

H0P-MC-CPMP (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP). 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have presence of diabetic peripheral neuropathy, of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument (©University of Michigan)
• Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
• Have an HbA1c <11% and on a stable regimen for treatment of diabetes at least 90 days prior to screening
• Have a body mass index at screening of ≤40 kilogram per meter squared (kg/m2)

Exclusion criteria

• Are pregnant or breastfeeding
• Have a history of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to diabetic peripheral neuropathic pain (DPNP)
• Have lower limb amputation due to diabetes inclusive of great toe (metatarsal bone)
• Have serum vitamin B12 ≤200 picogram per milliliter (pg/mL)
• Have an abnormal BP (systolic BP >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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 2 patient groups, including a placebo group

LY4065967

Experimental group

Description:

Participants will receive LY4065967 orally.

Treatment:

Drug: LY4065967

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally.

Treatment:

Drug: Placebo