NCT05110846已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus
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
- 103
- 试验地点
- 5
- 主要终点
- Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26
研究概览
简要总结
A study to assess the effect of CT-868 in lowering glycated hemoglobin A1c (HbA1c) in overweight and obese participants with inadequately controlled Type 2 diabetes mellitus (T2DM).
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
- •Males or Females with T2DM
- •BMI of ≥27 kg/m2, inclusive
- •18-75 years old, inclusive
- •Stable body weight for 3 months
排除标准
- •Significant medical history
- •Uncontrolled diabetes
- •History of malignancy
研究组 & 干预措施
Placebo
Placebo Comparator
Participants in the placebo arm received volume- and regimen-matched placebo.
干预措施: Placebo (Drug)
CT-868 1.75 mg
Experimental
Participants in the CT-868 1.75 mg arm received 1.0 mg/day for 2 weeks followed by 1.75 mg/day for the remaining treatment period.
干预措施: CT-868 (Drug)
CT-868 4.0 mg
Experimental
Participants in the CT-868 4.0 mg arm escalated through 1.0 mg/day for 2 weeks, 1.75 mg/day for 2 weeks, 2.5 mg/day for 4 weeks, 3.25 mg/day for 4 weeks, to 4.0 mg/day for the remaining 14 weeks.
干预措施: CT-868 (Drug)
结局指标
主要结局
Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26
时间窗: Baseline and Week 26
次要结局
- Change from Baseline in HbA1c at Week 12(Baseline and Week 12)
- Percentage of Participants Achieving HbA1c <5.7% at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants Achieving HbA1c ≤6.5% at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants Achieving HbA1c <7.0% at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percent Change from Baseline in Body Weight at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Absolute (kg) Change from Baseline in Body Weight at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants with ≥5% Body Weight Loss from Baseline at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants with ≥10% Body Weight Loss from Baseline at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants with ≥15% Body Weight Loss from Baseline at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants with ≥20% Body Weight Loss from Baseline at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Fasting Plasma Glucose at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Fasting Insulin at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Waist Circumference at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Hip Circumference at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Waist-to-Hip Ratio at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Waist-to-Height Ratio at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Body Mass Index (BMI) at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Total Cholesterol at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Triglycerides at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in High Density Lipoprotein (HDL) Cholesterol at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Apolipoprotein B at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants with at Least One Treatment-Emergent Adverse Event(From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks))
- Percentage of Participants with at Least One Hypoglycemic Event(From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks))
- Percentage of Participants Testing Positive for Anti-Drug Antibodies to CT-868 at Baseline and Anytime Post-Baseline(Baseline and Post-Baseline (up to 30 weeks))
研究者
研究点 (5)
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