Type 2 Diabetes Mellitus with Metabolic Dysfunction-associated Steatotic Liver Disease
Conditions
Interventions
Chiglitazar Sodium Group:Chiglitazar Sodium
Silymarin Group:Silymarin
Control Group:None
Sponsors
Zhongda Hospital of Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18--75 years (inclusive), without gender restriction; 2. Diagnosed with T2DM according to the 2010 ADA criteria; 3. BMI >= 18.5 kg/m² and = 5% of hepatocytes; (2). LFC >= 5% as determined by MRI-PDFF; (3). CAP >= 248 dB/m as determined by FibroScan; (4). Abdominal ultrasound or CT imaging indicative of fatty liver; 5. HbA1c <= 10.0% at screening, with stable treatment on diet, exercise, and/or conventional antihyperglycemic medications (metformin, sulfonylureas, glinides, a-glucosidase inhibitors, DPP-IV inhibitors, insulin) for at least 3 months; 6.Able to understand the clinical trial procedures and methods, willing to participate voluntarily, sign the informed consent form, and comply with the trial protocol requirements, including providing biological samples for testing as planned.
Exclusion criteria
Exclusion criteria: 1. History of acute diabetic complications (e.g., diabetic ketoacidosis, lactic acidosis, hyperosmolar hyperglycemic state) or acute comorbidities (e.g., cardiocerebrovascular diseases, respiratory failure) within 3 months prior to screening, or severe hypoglycemic events/repeated hypoglycemic episodes, or other diseases deemed by the investigator as unsuitable for study participation; 2. Liver diseases assessed by the investigator to potentially affect efficacy or patient safety evaluation (e.g., drug-induced, viral, alcoholic, autoimmune hepatitis), or ALT levels > 3 × ULN. 3.Any known severe renal disease or eGFR 1.5 mg/dL at screening; 4. Congestive heart failure (NYHA Class III or IV), or known left ventricular ejection fraction 800 IU/d), fibrates within 3 months prior to screening, or medications affecting fatty liver (e.g., THR-ß agonists, estrogens, tamoxifen, chloroquine, or other hepatotoxic drugs); 10. Use of thiazolidinediones, GLP-1 receptor agonists, SGLT2 inhibitors, or PPAR agonists within 3 months prior to screening; 11. Current enrollment in another clinical study involving investigational products, or any other medical research deemed scientifically or medically incompatible; 12. Participation in a clinical study involving investigational products within the last 30 days. If the prior investigational product has a long half-life, a washout period of five half-lives or 30 days (whichever is longer) is required; 13.Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LFC,Liver fat content; | — |
Secondary
| Measure | Time frame |
|---|---|
| LSM(Liver Serum Marker), CAP(community-acquired- pneumonia);Hepatic Enzymes;Glucose Metabolic Indicators;Lipid Metabolism Indicators;BMI, Waist; | — |
Countries
China
Contacts
Public ContactLing Li
Zhongda Hospital of Southeast University
Outcome results
None listed