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临床试验/NCT07570810
NCT07570810尚未招募不适用

A Single -Center, Randomized, Double-blind, Placebo-controlled Proof of Exploratory Study Evaluating the Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM

Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 30 人开始时间: 2026年6月1日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Percentage change in body weight relative to baseline
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is an exploratory study evaluating CS0159 in combination with Semaglutide in metabolic dysfunction-associated fatty liver disease (MAFLD) patients with obesity and type 2 diabetes (T2DM).

详细描述

This is an exploratory study to evaluate the efficacy, safety, and tolerability of CS0159 in combination with Semaglutide in MAFLD patients with obesity and T2DM. Approximately 30 patients were randomly assigned to two groups in a 1:1 ratio for treatment for 12 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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • •1. Age≥18 and ≤65 years, male or female.
  • •2. MRI-PDFF ≥10% within 3 months prior to randomized.
  • •3. Diagnosis of T2DM.
  • •4. HbA1c: 7.0%-10.5%.
  • •5. FPG: 7.0-13.3 mmol/L.
  • •6. BMI: 30-45 kg/m
  • •7. Subjects control blood glucose only by lifestyle intervention for at least 3 months before the screening period.
  • •8. 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.
  • •9. Can understand the research content, follow the research protocol, and voluntarily sign the ICF.

排除标准

  • •1. 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.
  • •2. Use of glucose-lowering medication in the 3 months prior to randomization.
  • •3. 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.
  • •4. 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.
  • •5. Subjects with T1DM, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes.
  • •6. Subjects with a history of severe pruritus.
  • •7. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
  • •8. Thyroid C-cell tumour or family history, multiple endocrine neoplasia type 2 or family history.
  • •9. History of acute or chronic pancreatitis.
  • •10. Subjects with Child-Pugh class B or C grade cirrhosis.
  • •11. HBsAg positive, HCV Ab positive, HIV Ab positive, TP Ab positive.
  • •12. 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.
  • •13. Diseases that interfere with the absorption, distribution, metabolism or excretion.
  • •14. Gastrointestinal diseases that affect food digestion and absorption.
  • •15. 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.
  • •16. History of malignant tumors within the first 5 years of randomization.
  • •17. 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.
  • •18. Drug abuse or alcohol abuse within the first 6 months of randomization.
  • •19. Poor blood pressure control.
  • •20. Mental illness, epilepsy.
  • •21. Patients with uncontrollable severe infectious diseases before randomization.
  • •22. Pregnant, planned pregnancy or breastfeeding.
  • •23. Participated in other clinical trials in the first three months of randomization.
  • •24. 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 12 weeks

干预措施: CS0159 (Drug)

4mg CS0159

Active Comparator

4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks

干预措施: Semaglutide (Drug)

CS0159 Placebo

Placebo Comparator

CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks

干预措施: CS0159 placebo (Drug)

CS0159 Placebo

Placebo Comparator

CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks

干预措施: Semaglutide (Drug)

结局指标

主要结局

Percentage change in body weight relative to baseline

时间窗: Baseline to 12 weeks

Evaluate the percentage change in body weight relative to baseline after 12 weeks of treatment.

Changes in energy expenditure

时间窗: Baseline to 12 weeks

The impact of the patient's energy expenditure change relative to the baseline after 12 weeks, assessed by whole-room indirect calorimetry (metabolic chamber).

次要结局

  • Change in patient's weight relative to the baseline(Baseline to 12 weeks)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Baseline to 12 weeks)
  • Change in patient's glucose oxidation(Baseline to 12 weeks)
  • Change in patient's lipid oxidation(Baseline to 12 weeks)
  • Percentage change in HbA1c relative to baseline(Baseline to 12 weeks)
  • Changes relative to baseline in BMI(Baseline to 12 weeks)
  • Changes relative to baseline in body composition(Baseline to 12 weeks)
  • Changes relative to baseline in waist circumference(Baseline to 12 weeks)
  • Changes relative to baseline in waist to hip ratio (WHR)(Baseline to 12 weeks)
  • Changes relative to baseline in serum liver function parameters(Baseline to 12 weeks)
  • Changes relative to baseline in serum lipid profile(Baseline to 12 weeks)
  • Changes relative to baseline in plasma glucose levels(Baseline to 12 weeks)
  • Changes relative to baseline in serum insulin levels(Baseline to 12 weeks)
  • Changes in peripheral blood metabolomics and proteomics relative to baseline(Baseline to 12 weeks)
  • Changes in fecal metabolites, gut microbiota homeostasis, and fecal gut microbiota metagenome relative to baseline(Baseline to 12 weeks)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Weiqing

Professor, PHD, MD

Shanghai Jiao Tong University School of Medicine

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