NCT06694935招募中1 期
A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus (T2DM) Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
1Globe Health Institute1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年1月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Recommended Phase 2 Dose (RP2D)
研究概览
简要总结
This is an open label phase 1b trial of QX1206 in patients with T2DM and with NAFLD. Laboratory tests and other measurements will be assessed prior to the first dose of study treatment and throughout the study to determine the recommended phase 2 dose. In addition, the preliminary effects of QX1206 on antidiabetic activity and other metabolic parameters will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent must be obtained and documented
- •18 years of age and < 65 years old
- •BMI ≥ 18 kg/m^2 and < 45 kg/m^2
- •T2DM diagnosed per 2021 American Diabetes Association criteria
- •Diagnosis of NAFLD
- •For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study
- •Women of child-bearing potential (WOCBP) must have a negative pregnancy test
- •Serum creatinine < 1.5×ULN or creatinine clearance ≥ 60 ml/min
- •Participating patients must be able to comply with all study requirements and the study center must have appropriate means of ensuring protocol compliance for each participating patient
排除标准
- •Uncontrolled diabetes
- •Patients with an active, serious medical disease that limit activities of daily living
- •Patients with current, significant alcohol consumption or a history of significant alcohol consumption
- •Patients with any of the following clinical laboratory abnormalities at screen and confirmed by a single repeat if deemed necessary:
- •Fasting triglycerides > 500 mg/dL
- •Fasting direct LDL-C > 190 mg/dL
- •AST > 5.0 × upper limit of normal (ULN)
- •ALT > 5.0 × ULN
- •Alkaline phosphatase (ALP) ≥ 2 × ULN
- •HbA1c > 10.5%
- •Fasting plasma glucose (FPG) > 240 mg/dL (13.3 mmol/L)
- •Platelets count < 140,000/mm^3
- •Patient takes drugs historically associated with NAFLD and other known hepatotoxins
- •Treatment with drugs (e.g., vitamin E > 400 IU/day) or herbal supplements with potential anti-NAFLD effect
研究组 & 干预措施
QX1206
Experimental
干预措施: QX1206 (Drug)
结局指标
主要结局
Recommended Phase 2 Dose (RP2D)
时间窗: Baseline Day 1 up to Week 12
次要结局
- Hemoglobin A1c (HbA1c)(12 Weeks)
- Fasting plasma glucose (FPG)(12 Weeks)
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)(12 Weeks)
- Fasting insulin(12 Weeks)
研究者
研究点 (1)
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