NCT06492330已完成不适用
A Multi-center, Randomized, Double-blind, Placebo-controlled Proof of Concept Study Evaluating the Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MASH Patients With Obesity and T2DM
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年7月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Percentage change in body weight relative to baseline
研究概览
简要总结
This is an exploratory study evaluating CS0159 in combination with Semaglutide in MASH patients with obesity and T2DM.
详细描述
This is an exploratory study to evaluate the efficacy, safety, and tolerability of CS0159 in combination with Semaglutide in MASH patients with obesity and T2DM. A total of 60 patients will be recruited. BMI ≥35 kg/m2 will be used as a randomized stratification factor, and patients will be randomly assigned in a 1:1 ratio.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 and ≤65 years, male or female.
- •Patients with previous liver biopsy for MASH or MRI-PDFF ≥10% within 3 months prior to randomization.
- •Diagnosis of T2DM.
- •HbA1c: 7.0%-10.5%.
- •FPG: 7.0-13.3 mmol/L.
- •BMI: 30-45 kg/m
- •Subjects control blood glucose only by lifestyle intervention for at least 3 months before the screening period.
- •Willing to maintain consistent diet and exercise habits throughout the entire study, and adhere to the study protocol for timely administration of the study drug, and timely self-monitoring of blood glucose and recording.
排除标准
- •ALT≥2.5×ULN, AST≥2.5×ULN, TBil≥2×ULN, creatinine (Cr) ≥1.5×ULN and Serum creatinine clearance<60 mL/min, PLT<100×10^9/L, INR >1.3, ALB <3.5 g/dL.
- •Use of glucose-lowering medication in the 3 months prior to randomization.
- •Weight loss ≥ 5% in the 3 months prior to randomization or ≥10% in the 6 months prior to randomization or use of other weight-lowering drugs, corticosteroids, and etc.
- •History of allergy to glucagon-like peptide-1 receptor agonists (GLP-1RA) medications, currently in an allergic state, having allergic conditions, or history of allergies to ≥2 substances.
- •Subjects with T1DM, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes.
- •Subjects with a history of severe pruritus.
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- •Thyroid C-cell tumour or family history, multiple endocrine neoplasia type 2 or family history.
- •History of acute or chronic pancreatitis.
- •Subjects with Child-Pugh class B or C grade cirrhosis.
- •HBsAg positive, HCV Ab positive, HIV Ab positive, TP Ab positive.
- •Arrhythmias, male QTc≥450 ms, or female QTc≥470 ms. Or cardiovascular disease for which the researcher has assessed that participation in the trial is not appropriate.
- •Diseases that interfere with the absorption, distribution, metabolism or excretion.
- •Gastrointestinal diseases that affect food digestion and absorption.
- •Use moderate or strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A4 enzyme) within the first 14 days of randomization and throughout the entire trial period.
- •History of malignant tumors within the first 5 years of randomization.
- •Serious hypoglycemic events occurring ≥ 3 times within 12 weeks prior to administration, or acute and severe metabolic disorder occurred within 12 weeks prior to administration.
- •Drug abuse or alcohol abuse within the first 6 months of randomization.
- •Poor blood pressure control.
- •Mental illness, epilepsy.
- •Patients with uncontrollable severe infectious diseases before randomization.
- •Pregnant, planned pregnancy or breastfeeding.
- •Participated in other clinical trials in the first three months of randomization.
- •Any condition that in the judgement of the researcher precludes participation.
研究组 & 干预措施
4mg CS0159
Active Comparator
4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 16 weeks
干预措施: CS0159 (Drug)
CS0159 Placebo
Placebo Comparator
CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 16 weeks
干预措施: CS0159 placebo (Drug)
结局指标
主要结局
Percentage change in body weight relative to baseline
时间窗: Baseline to 16 weeks
Evaluate the percentage change in body weight relative to baseline after 16 weeks of treatment.
次要结局
- 2-hour post-prandial plasma glucose levels(Baseline to 16 weeks)
- Changes relative to baseline in body mass index (BMI)(Baseline to 16 weeks)
- Proportion of subjects achieving ≥5% weight loss(Baseline to 16 weeks)
- Fasting plasma glucose levels(Baseline to 16 weeks)
- Fasting serum C peptide levels(Baseline to 16 weeks)
- Changes relative to baseline in waist circumference and waist-to-hip ratio (WHR)(Baseline to 16 weeks)
- Changes relative to baseline in parameters of hepatic fibrosis(Baseline to 16 weeks)
- 2-hour post-prandial serum insulin levels(Baseline to 16 weeks)
- 2-hour post-prandial serum C peptide levels(Baseline to 16 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Baseline to 16 weeks)
- Percentage change in HbA1c relative to baseline(Baseline to 16 weeks)
- Fasting serum insulin levels(Baseline to 16 weeks)
- Percentage change in liver fat content relative to baseline(Baseline to 16 weeks)
- Changes relative to baseline in renal function(Baseline to 16 weeks)
- Patient Health Questionnaire 9 (PHQ-9)(Baseline to 16 weeks)
- Short form 36 health survey questionnaire (SF-36)(Baseline to 16 weeks)
- Visual analog scale for pruritus and 5-D itch scale(Baseline to 16 weeks)
- Changes relative to baseline in body composition(Baseline to 16 weeks)
- Changes relative to baseline in liver function(Baseline to 16 weeks)
- Changes relative to baseline in lipid profile(Baseline to 16 weeks)
研究者
Wang Weiqing
Professor, PHD, MD
Shanghai Jiao Tong University School of Medicine
研究点 (1)
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