Chiglitazar for NASH

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a non-invasive exploratory phase II trial. Among patients who were clinically diagnosed as non-alcoholic steatohepatitis (NASH) with liver fibrosis accompanied by elevated triglycerides (TG) and insulin resistance, the efficacy and safety of chiglitazar sodium tablets 48mg , 64mg or placebo qd for 18 weeks were observed. The result will provide support for future clinical studies of Chiglitazar Sodium in the treatment of NASH.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chipscreen Biosciences, Ltd.

Criteria

Inclusion Criteria:

1. Before any evaluation, an informed consent form voluntarily signed by the patient must be obtained;

2. 18 -75 years old (at the time of screening visit V1), male or female;

3. MRI-PDFF ≥ 8% ;

4. Liver stiffness value ( LSM ) 7.0-11.0kPa ;

5. Triglyceride ( TG ) ≥1.7mmol/L and ≤5.6 mmol/L;

6. HOMA-IR ≥ 2.5 ;

7. Serum Alanine aminotransferease (ALT) ≥ the upper limit of normal during screening.

Exclusion Criteria:

1. Type 1 diabetes;

2. Any of the following for type 2 diabetes:

• HbA1c ≥ 8.5% during screening

• At the time of screening, ≥ 2 oral hypoglycemic drugs combinations

• Receiving any of the following medications at screening: Thiazolidinediones (TZD) drugs, fibrates, glucagon-like peptide-1 (GLP-1) receptor agonists, insulin

3. Existing other liver diseases or history of liver diseases

4. History of transient ischemic attack or cerebrovascular accident;

5. History of myocardial infarction, or coronary angioplasty or coronary artery bypass surgery, unstable angina, heart failure (New York Heart Association NYHA grade III / IV ), or ECG signs of left ventricular hypertrophy, or serious arrhythmias ；

6. During screening, blood pressure ≥ 160/100 mmHg ;

7. Previous or planned ( during the study period) bariatric surgery;

8. Liver transplantation history or planned liver transplantation;

9. Liver biopsy show liver cirrhosis or clinically diagnosed as cirrhosis;

10. Weight loss of more than 5% in 6 months before screening;

11. History of edema of lower limbs or whole body;

12. diagnosed as osteoporosis or any other known bone disease;

13. Donated blood or lost blood >400 ml within 8 weeks before the first medication;

14. With MRI scan contraindications;

15. In the past 5 years, there was a history of malignant tumors of any organ system;

16. Human immunodeficiency virus ( HIV ) test is positive;

17. Heavy drinking of alcohol for more than 3 months in a year;

18. Heavy smoking >30 per day within 1 year;

19. History of drug abuse in 12 months;

20. Drugs cumulatively for more than 1 month in the previous 3 months before screening, such as obeticholic acid ( OCA ), berberine;

21. Drugs that may cause liver damage for more than 2 weeks within 1 year before screening;

22. Patients received the following medications unless they have received a stable dose for at least 1 month before screening :Beta-blockers, thiazide diuretics, statins, niacin, ezetimibe, thyroid hormone;

23. The calculated eGFR < 60 mL/(min*1.73m^2 );

24. There is clinical evidence of liver decompensation or severe liver damage;

25. Low density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L during screening ;

26. Platelet < 100×10^9 /L ;

27. Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening ;

28. Pregnant or breastfeeding women.