nonalcoholic fatty liver disease
Conditions
Interventions
Chiglitazar Sodium Tablets 48mg:Lifestyle intervention + Chiglitazar Sodium Tablets 48mg orally
Placebo:Lifestyle intervention + placebo Oral
Sponsors
Fudan University, Shanghai Fifth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old, no restrictions on gender and ethnicity. The diagnosis of NAFLD conforms to the "Diagnostic Criteria for Non-Alcoholic Fatty Liver Disease" issued by the Fatty Liver and Alcoholic Liver Disease Group of the Chinese Medical Association in 2018, and the diagnosis of T2DM conforms to the 1999 WHO promulgation.the diagnostic criteria for diabetes; 2. FibroScan-AST (FAST) score > 0.35; 3. Body mass index (BMI) 19~35 kg/m^2; 4. The effect of lifestyle interventions such as diet is not good, and the patient has not taken any hypoglycemic drugs in the past 3 months, or has taken a stable dose of hypoglycemic drugs that allow for concomitant treatment; 5. Glycated hemoglobin (HbA1c) 7.5-11%; 6. Women of childbearing age have a negative pregnancy test before the first dose of the study drug and agree to take effective contraceptive measures during the study; 7. Voluntary signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Combined with other acute and chronic active liver diseases (such as viral hepatitis, hereditary hemochromatosis, hepatolenticular degeneration, ?-antitrypsin deficiency, alcoholic liver disease, drug-related liver disease, etc.); 2. Type 1 diabetes (T1DM) patients; 3. Surgery planned during the trial; 4. Inability to stabilize blood pressure (systolic > 160 mmHg or diastolic > 100 mmHg) with daily stable doses of antihypertensive medication within 1 month prior to randomization; 5. With significant renal disease, such as estimated glomerular filtration rate (eGFR) value calculated from the CKD-E PI creatinine formula 13.0 mmol/L; 8. Triglyceride (TG)>5.7 mmol/L; 9. Uncontrolled hypothyroidism (thyroid stimulating hormone (TSH) >= 10mIU/L); 10. History of medical history that affects drug absorption, distribution, and metabolism (eg, inflammatory bowel disease, history of gastrointestinal surgery, chronic pancreatitis, gluten allergy, vagotomy, etc.); 11. Received the following drugs within 1 month before randomization: thiazolidinediones, glucagon-like peptide-1 (GLP-1), vitamin E, and other NASH drugs; 12. Diagnosed with active malignancy; 13. Active implantable medical devices (such as pacemakers or defibrillators); 14. Received clinical trials of other investigational drugs 3 months prior to screening; 15. Pregnant or breastfeeding women who plan to give birth in the near future; 16. Known or suspected allergy or intolerance to the investigational drug or its ingredients; 17. Inability to fill in the diary card correctly, inability to perform self-management of diet and exercise, poor compliance, abuse and dependence on alcohol and/or drugs, and other circumstances that the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FibroScan-AST (FAST) score; | — |
Countries
China
Contacts
Public ContactShufei Zang
Fudan University, Shanghai Fifth People's Hospital
Outcome results
None listed