NCT07641504招募中2 期
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Chronic Low Back 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
- 81
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 chronic low back pain (CLBP). 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 a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation
- •Have a body mass index at screening of ≤40 kilograms per meter squared (kg/m²).
- •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 used a therapeutic injection to the spine in the 3 months prior to screening
- •Are using a spinal cord stimulator or dorsal root ganglion stimulator
- •Have ongoing complex regional pain syndrome or other concurrent medical conditions that could interfere with the evaluation of CLBP
- •Have a history of major spinal deformity, such as spondylolisthesis, spondylolysis, scoliosis, or spina bifida, that causes instability to the spine
- •Have an abnormal blood pressure (BP) systolic BP is 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 (81)
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