Phase I Study of RTA 402 in Obese Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Changes from baseline in fat mass measured by Dual Energy X-ray Absorption
研究概览
简要总结
To investigate changes in body weight and body composition in obese adults after repeated oral administration of RTA 402 once daily for 16 weeks, using placebo as a control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written voluntary informed consent to participate in the study
- •Male aged ≥ 20 and < 50 years at the time of consent
- •BMI ≥ 25.0 kg/m2 measured at screening
- •Waist circumference (umbilical position) ≥ 85 cm measured at screening.
- •MRI-measured visceral fat area ≥ 100 cm2 measured at screening
排除标准
- •Subjects who have undergone weight control procedures (weight loss medicine, surgical therapy, exercise therapy, bariatric diet, etc.) at a medical institution within 3 months before the screening
- •Subjects with conditions requiring treatment other than obesity
- •History of cardiac failure (e.g., a prior diagnosis of congestive cardiac failure defined as NYHA class III or IV or a history of hospitalization for cardiac failure)
研究组 & 干预措施
RTA 402 5mg or 10mg oral administration
干预措施: Bardoxolone methyl (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in fat mass measured by Dual Energy X-ray Absorption
时间窗: Through study completion, approximately 6 months
Changes from baseline in lean body mass measured by Dual Energy X-ray Absorption
时间窗: Through study completion, approximately 6 months
Changes from baseline in muscle mass measured by Magnetic Resonance Imaging
时间窗: Through study completion, approximately 6 months
Changes from baseline in body fat mass measured by Bioelectrical Impedance Analysis
时间窗: Through study completion, approximately 6 months
Changes from baseline in segmental muscle mass measured by Bioelectrical Impedance Analysis
时间窗: Through study completion, approximately 6 months
Changes from baseline in extracellular water measured by Bioelectrical Impedance Analysis
时间窗: Through study completion, approximately 6 months
Changes from baseline in skeletal muscle mass index measured by Dual Energy X-ray Absorption
时间窗: Through study completion, approximately 6 months
Changes from baseline in waist
时间窗: Through study completion, approximately 6 months
Changes from baseline in grip
时间窗: Through study completion, approximately 6 months
Changes from baseline in abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging
时间窗: Through study completion, approximately 6 months
Changes from baseline in weight measured by Bioelectrical Impedance Analysis
时间窗: Through study completion, approximately 6 months
Changes from baseline in visceral adipose tissue measured by Magnetic Resonance Imaging
时间窗: Through study completion, approximately 6 months
Changes from baseline in total body water measured by Bioelectrical Impedance Analysis
时间窗: Through study completion, approximately 6 months
Changes from baseline in basal metabolic rate measured by Bioelectrical Impedance Analysis
时间窗: Through study completion, approximately 6 months
次要结局
未报告次要终点