NCT06277934已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of RGT001-075 Compared With Placebo in Adult Patients With Obesity or Overweight With Weight-Related Comorbidities
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings
研究概览
简要总结
The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years
- •Have a BMI ≥27 kg/m² and ≤ 45 kg/m²
- •Have had a stable body weight for the 3 months prior to randomization
排除标准
- •Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
- •Have a prior or planned surgical treatment for obesity
- •Have or plan to have endoscopic and/or device-based therapy for obesity
- •Have any prior diagnosis of diabetes
- •Have an electrocardiogram (ECG) with abnormalities
- •Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders within the last 2 years
- •Have a history of suicide attempt.
研究组 & 干预措施
RGT001-075 Group
Experimental
Patients will receive once daily dose of study drug for a total of 12 weeks
干预措施: RGT001-075 (Drug)
Placebo Group
Placebo Comparator
Patients will receive once daily dose of matching placebo for a total of 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings
时间窗: 14 weeks
次要结局
- Change in waist circumference in centimetre(12 weeks)
- RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf)(12 weeks)
- Percent change in body weight(12 weeks)
- Change in body weight in kilogram(12 weeks)
- Percentage of participants who achieve ≥5% and ≥10% body weight reduction(12 weeks)
- Change in Body mass index (BMI) in kg/m^2(12 weeks)
- RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last)(12 weeks)
- RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax)(12 weeks)
- RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax)(12 weeks)
- RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2)(12 weeks)
研究者
研究点 (1)
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