NCT07285018招募中2 期
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Diabetic Peripheral Neuropathic Pain
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 37
- 主要终点
- Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
LY4065967
Experimental
Participants will receive LY4065967 orally.
干预措施: LY4065967 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
时间窗: Baseline, Week 8
次要结局
- Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score(Baseline, Week 8)
- Change from Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGI-C)(Baseline, Week 8)
- Change from Baseline in Worst Pain Intensity as Measured by NRS(Baseline, Week 8)
- Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)(Baseline, Week 8)
- Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)(Baseline, Week 8)
- Total Amount of Rescue Medication Used Daily During the Treatment Phase(Week 8)
研究者
研究点 (37)
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