A Randomized, Double-blind, Placebo-controlled Proof-of-concept Parallel Group Clinical Trial to Investigate the Efficacy, Safety and Tolerability of Weekly Subcutaneous Dosing of CK-0045 in Participants With Overweight/Obesity and Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h))
研究概览
简要总结
The goal of this clinical trial is to learn if treatment with CK-0045 improves blood sugar control after a meal in participants with type 2 diabetes mellitus (T2DM) and overweight/obesity. It also aims to learn if CK-0045 can reduce body weight in these patients.
The main question it aims to answer is:
• Does 16 weeks of treatment with CK-0045 improve blood sugar control after a meal in participants with overweight or obesity and T2DM? Researchers will compare two dose levels of CK-0045 to a placebo arm (a look-alike substance that contains no drug) to see if CK-0045 improves blood sugar control.
Participants will:
- Have CK-0045 or placebo injected subcutaneously (under the skin) once weekly over a period of 16 weeks.
- Visit the clinic 24 times and stay overnight at 2 of the visits.
- During the visits blood samples will be collected and several other assessments/examinations will be performed to learn about the effects (and potential side effects) of CK-0045.
详细描述
Phase 2a, randomized, double-blind, placebo-controlled, parallel group trial with weekly SC dosing of CK-0045 (2 dose levels) or placebo over 16 weeks followed by 8 weeks of follow-up in participants with overweight / obesity and T2DM. The total duration of involvement for each participant, screening through follow-up, will be approximately 30 weeks.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-74 years old male or female diagnosed with type 2 diabetes mellitus ≥ 6 months prior to screening
- •Body Mass Index (BMI) between 27.0 and 40.0 kg/m^2 at screening
- •Treated with diet and exercise
- •HbA1c 6.5-8.5%, both inclusive, at screening for participants taking 3 antidiabetic medications or HbA1c 6.5-9.0%, both inclusive, at screening for participants taking 2 or less antidiabetic medications at stable doses for at least 3 months prior to screening
排除标准
- •Any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure or any other clinically significant history or evidence of poorly controlled cardiovascular disorder(s) as judged by the investigator.
- •Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction), have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, gastric banding ), and/or device-based therapy for obesity, or have had device removal within the past 6 months.
- •History or signs of clinically relevant skin diseases including but not limited to: psoriasis, atopic dermatitis, eczema, etc., as judged by the investigator.
研究组 & 干预措施
CK-0045 Dose level 2
干预措施: CK-0045 (Drug)
CK-0045 Dose level 1
干预措施: CK-0045 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h))
时间窗: 16 weeks
次要结局
- Change from baseline in body weight(16 weeks)
- Change from baseline in total cholesterol, HDL-, LDL-cholesterol, triglycerides, free fatty acids (FFA), and Lp(a)(16 weeks)
- Change from baseline in HbA1c(16 weeks)
- Ctrough, observed(168 hours)
- Incidence of adverse events(24 weeks)