Status:
COMPLETED
A Phase II Clinical Trial of Chiglitazar for NASH
Lead Sponsor:
Chipscreen Biosciences, Ltd.
Conditions:
NASH
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The study is to evaluate the efficacy and safety of chiglitazar monotherapy in patients with non-clcoholic steatohepatitis (NASH).
Detailed Description
The study is a non-invasive exploratory phase II trial in patients who were clinically diagnosed as non-alcoholic steatohepatitis (NASH) with liver fibrosis accompanied by elevated triglycerides (TG) ...
Eligibility Criteria
Inclusion
- Before any evaluation, an informed consent form voluntarily signed by the patient must be obtained;
- 18 -75 years old (at the time of screening visit V1), male or female;
- MRI-PDFF ≥ 8% ;
- Liver stiffness value ( LSM ) 7.0-11.0kPa ;
- Triglyceride ( TG ) ≥1.7mmol/L and ≤5.6 mmol/L;
- HOMA-IR ≥ 2.5 ;
- Serum Alanine aminotransferease (ALT) ≥ the upper limit of normal during screening.
Exclusion
- Type 1 diabetes;
- 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
- Existing other liver diseases or history of liver diseases
- History of transient ischemic attack or cerebrovascular accident;
- 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 ；
- During screening, blood pressure ≥ 160/100 mmHg ;
- Previous or planned ( during the study period) bariatric surgery;
- Liver transplantation history or planned liver transplantation;
- Liver biopsy show liver cirrhosis or clinically diagnosed as cirrhosis;
- Weight loss of more than 5% in 6 months before screening;
- History of edema of lower limbs or whole body;
- diagnosed as osteoporosis or any other known bone disease;
- Donated blood or lost blood \>400 ml within 8 weeks before the first medication;
- With MRI scan contraindications;
- In the past 5 years, there was a history of malignant tumors of any organ system;
- Human immunodeficiency virus ( HIV ) test is positive;
- Heavy drinking of alcohol for more than 3 months in a year;
- Heavy smoking \>30 per day within 1 year;
- History of drug abuse in 12 months;
- Drugs cumulatively for more than 1 month in the previous 3 months before screening, such as obeticholic acid ( OCA ), berberine;
- Drugs that may cause liver damage for more than 2 weeks within 1 year before screening;
- 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;
- The calculated eGFR \< 60 mL/(min\*1.73m\^2 );
- There is clinical evidence of liver decompensation or severe liver damage;
- Low density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L during screening ;
- Platelet \< 100×10\^9 /L ;
- Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening ;
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2024
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT05193916
Start Date
March 21 2022
End Date
January 2 2024
Last Update
May 28 2024
Active Locations (15)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
2
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
3
Peking University People's Hospital
Beijing, Beijing Municipality, China
4
The First Hospital of Lanzhou University
Lanzhou, Gansu, China