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

Официальное название

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Diabetic Peripheral Neuropathic Pain

Обзор

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.

Вмешательства

• Препарат LY4065967
  Administered orally
• Препарат Placebo
  Administered orally

Первичные конечные точки

• Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [Срок оценки: Baseline, Week 8]

Вторичные конечные точки (6)

• Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score [Срок оценки: Baseline, Week 8]
• Change from Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGI-C) [Срок оценки: Baseline, Week 8]
• Change from Baseline in Worst Pain Intensity as Measured by NRS [Срок оценки: Baseline, Week 8]
• Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) [Срок оценки: Baseline, Week 8]
• Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L) [Срок оценки: Baseline, Week 8]
• Total Amount of Rescue Medication Used Daily During the Treatment Phase [Срок оценки: Week 8]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 36 центров

• 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
• … и ещё 28 центров

Пуэрто-Рико · 1 центр

• Ponce Medical School Foundation Inc. — Ponce

Идентификаторы

NCT: NCT07285018 · 27370 · H0P-MC-NP07 · H0P-MC-CPMP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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