NCT04838405已完成1 期
A Phase 1 Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise Healthy Overweight and Obese Adult Participants and in Obese Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events as assessed by self-report
研究概览
简要总结
This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females
- •18-65 years old, inclusive
- •BMI 27.0-40.0, inclusive
- •Stable body weight for 2 months
排除标准
- •Significant medical history
- •Uncontrolled hypertension
- •History of malignancy
研究组 & 干预措施
CT-388
Experimental
SC dose of CT-388
干预措施: CT-388 (Drug)
Placebo
Placebo Comparator
SC dose of placebo matching CT-388 dose
干预措施: Placebo (Drug)
CT-388 Optional
Experimental
SC dose of CT-388
干预措施: CT-388 (Drug)
CT-388 MD
Experimental
SC dose of CT-388
干预措施: CT-388 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events as assessed by self-report
时间窗: Baseline up to 24 weeks
Safety and tolerability
次要结局
- Area under the concentration versus time curve (AUC)(Baseline up to 24 weeks)
- Maximum observed drug concentration (Cmax)(Baseline up to 24 weeks)
- Elimination half-life(Baseline up to 24 weeks)
- Change in mean body weight(Baseline up to 24 weeks)
- Change in mean glucose levels(Baseline up to 24 weeks)
- Change in mean insulin levels(Baseline up to 24 weeks)
研究者
研究点 (2)
Loading locations...
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