A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a Phase 1 study designed to assess the safety and tolerability of MEDI0382 (Cotadutide) in Japanese T2DM patients.
详细描述
This is a randomized, blinded, placebo-controlled study designed to evaluate the safety, tolerability, PK and efficacy of ascending doses of Cotadutide in Japanese obese subjects with T2DM. Approximately 20 subjects will be screened in total and 16 subjects will be randomized to Cotadutide or placebo in a 3:1 ratio. Those subjects who receive Cotadutide will be titrated up to HCTD. The study has a 2-week screening period, a run-in period of 9 days and an up to 7-week up-titration treatment period followed by a 3-week treatment extension period (if applicable), followed by a 28-day follow-up period.
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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo administered subcutaneously
干预措施: Placebo (Drug)
Cotadutide
Cotadutide administered subcutaneously
干预措施: Cotadutide (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Incidence of treatment-emergent serious adverse events (TESAEs)
时间窗: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Clinically important changes in 12-lead electrocardiogram (ECG)
时间窗: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Vital signs as measured by pulse rate (bpm)
时间窗: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Vital signs as measured by blood pressure (mmHg)
时间窗: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
ABPM (Ambulatory blood pressure monitoring) to measure pulse rate (bpm) and blood pressure (mmHg)
时间窗: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Physical examination (abnormality to be reported as part of adverse events)
时间窗: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
Clinical laboratory evaluations
时间窗: Baseline until the follow-up period, 28 days post-last dose
To assess the safety and tolerability of Cotadutide
次要结局
- Change in percentage time spent in hyperglycemia (> 140 mg/dL)(At baseline through end of study, 98 days in total)
- Change in percentage time spent in normoglycemia (70 -140 mg/dL)(At baseline through end of study, 98 days in total)
- Change in percentage time spent in clinically significant hypoglycemia (< 54 mg/dL)(At baseline through end of study, 98 days in total)
- Change in estimated hemoglobin A1c (HbA1c)(At baseline through end of study, 98 days in total)
- Change in fasting plasma glucose (mg/dL)(At baseline through end of study, 98 days in total)
- Change in HbA1c(At baseline through end of study, 98 days in total)
- Percentage change in body weight(At baseline through end of study, 98 days in total)
- Absolute change in body weight (kg)(At baseline through end of study, 98 days in total)
- Proportion of subjects achieving > 5% body weight loss(At baseline through end of study, 98 days in total)
- Area under the concentration-time curve (AUC) during the dosing interval (AUCtau)(Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks)
- Maximum observed concentration (Cmax)(Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks)
- Time to Cmax (tmax)(Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks)
- Trough plasma concentration (Ctrough)(Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks)
- Anti-drug antibodies (ADAs) to Cotadutide(At baseline through end of study, 98 days in total)
- Change in average glucose levels (mg/dL)(At baseline through end of study, 98 days in total)
- Change in coefficient of variation(At baseline through end of study, 98 days in total)