NCT07641517招募中2 期
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Osteoarthritis
适应症
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
- 80
研究概览
简要总结
The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to osteoarthritis (OA). 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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have presence of index knee pain for more than 12 weeks at screening
- •Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee
- •Have a body mass index ≤40 kilograms per meter squared (kg/m²) (inclusive)
- •Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening
排除标准
- •Are pregnant or breastfeeding
- •Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to screening
- •Have presence of surgical hardware or other foreign body in the index knee
- •Have ongoing complex regional pain syndrome or other concurrent medical condition that could interfere with the evaluation of pain in the index knee.
- •Have had any joint replacement of the lower extremity, such as hip, knee or ankle, in the 6 months prior to screening
- •Have an abnormal blood pressure (BP) (systolic BP greater than 140 millimeters mercury (>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
LY4065967 administered orally.
干预措施: LY4065967 (Drug)
Placebo
Placebo Comparator
Placebo administered orally.
干预措施: Placebo (Drug)
研究者
研究点 (80)
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