NCT07668180尚未招募2 期
A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of IN-207907 Injection in Elderly Patients With Sarcopenia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
The goal of this clinical trial is to learn if intervention can treat sarcopenia in the elderly. Researchers will compare IN-207907 120 mg, 240 mg, 360 mg and placebo to see if SPPB score improves.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥ 65 years (for female subjects, those who are medically unable to become pregnant)
- •Subjects diagnosed with sarcopenia in accordance with the Korean Working Group on Sarcopenia (KWGS) guidelines
- •Subjects with a body weight of ≥ 35 kg and a body mass index (BMI) of ≥ 15 kg/m² and < 30 kg/m²
- •Subjects with a nutritional status screening score of ≥ 8 as assessed by the Mini Nutritional Assessment (MNA) questionnaire
排除标准
- •Subjects with a history of diseases or surgical procedures that may affect physical activity or function
- •Subjects with underlying muscle disorders, including myopathy or muscular atrophy
- •Subjects with neuromuscular or neurological disorders
- •Subjects with uncontrolled diabetes mellitus, severe renal impairment, uncontrolled thyroid disorders, vitamin D deficiency, severe hepatic impairment, severe cardiac disease, uncontrolled hypertension, respiratory disorders
- •Subjects with clinically significant findings on a 12-lead electrocardiogram (ECG)
- •Subjects who are positive for active hepatitis B, active hepatitis C, syphilis, or human immunodeficiency virus
- •Subjects with a history of malignancy within 5 years
- •Subjects who have received systemic immunosuppressants or immunostimulants
- •Subjects who have undergone treatment with plasmapheresis within 8 weeks
- •Subjects who have received treatment with medications prohibited in this clinical trial within 4 weeks
- •Subjects with hemoglobin levels < 10 g/dL
- •Subjects who have undergone surgery requiring general anesthesia within 4 weeks
- •Subjects who are unable to walk or are physically inactive
- •Subjects who are participating in or planning to participate in a separate high-intensity program for increasing muscle mass or strength during the clinical trial period
- •Subjects with severe psychiatric disorders such as major depression, schizophrenia, alcoholism, or drug dependence
- •Subjects with a score of < 24 on the Korean version of the Mini Mental State Examination (MMSE-K)
- •Subjects with known allergies or hypersensitivity to the investigational product or its excipients
研究者
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