A Phase Ib, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse event leading to the discontinuation of study intervention (DAEs), death, and Adverse events of special interest (AESIs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and PK of AZD5004 compared with placebo in Chinese participants with overweight/obesity with or without T2DM.
详细描述
This is a Phase Ib, randomized, parallel-group, double-blind, placebo-controlled, multicentre, 2-arm treatment study to investigate the safety, tolerability, and PK of AZD5004 compared with placebo in Chinese male and female participants aged 18 to 74 years, who are overweight/obese with or without T2DM. The primary endpoints are incidence of AEs, SAEs, DAEs, death, AESIs, laboratory parameters, 12-lead ECG, and vital signs.
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
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 74 years inclusive at the time of signing the informed consent.
- •Stable self-reported body weight for 3 months prior to Screening.
- •Inclusion Criteria for Cohort A:
- •- 27 kg/m2 ≤ BMI ≤ 35 kg/m2 and weigh at least 60 kg at Screening.
- •Inclusion Criteria for Cohort B:
- •Diagnosed with T2DM for at least 6 months prior to signing the informed consent.
- •HbA1c value at Screening of ≥ 7.0% and ≤ 10.5%
- •BMI of ≥ 24 kg/m2 at the Screening Visit.
排除标准
- •History of, or any existing condition that influence the participant's ability to participate or affect the interpretation of the results of the study.
- •Known clinically significant gastric emptying abnormality.
- •Significant hepatic disease.
- •Abnormal renal function.
- •History of acute pancreatitis and chronic pancreatitis, gallstones.
- •Uncontrolled thyroid disease.
研究组 & 干预措施
AZD5004
Participants will receive AZD5004 orally.
干预措施: AZD5004 (Drug)
Placebo
Participants will receive Placebo orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse event leading to the discontinuation of study intervention (DAEs), death, and Adverse events of special interest (AESIs)
时间窗: From baseline to week 16.
To evaluate the safety and tolerability of AZD5004 compared with placebo.
次要结局
- AZD5004 concentrations in plasma(Week 16.)
- Area under the concentration-time curve over a dosing interval (AUCtau)(Week 16.)
- Maximum Observed Plasma Concentration (Cmax)(Week 16.)
- Half-Life (t1/2)(Week 16.)
- Time of Occurrence of Maximum Plasma Concentration (tmax)(Week 16.)
- Trough concentration (Ctrough)(Week 16.)