Phase
Condition
N/ATreatment
chiglitazar sodium tablets
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Before any evaluation, an informed consent form voluntarily signed by the patientmust 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
Exclusion Criteria:
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 bypasssurgery, 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 beforescreening;
Patients received the following medications unless they have received a stable dosefor 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 3months prior to screening ;
Pregnant or breastfeeding women.
Study Design
Study Description
Connect with a study center
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing 100050
ChinaSite Not Available
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing
ChinaSite Not Available
Peking University People's Hospital
Beijing, Beijing
ChinaSite Not Available
The First Hospital of Lanzhou University
Lanzhou, Gansu
ChinaSite Not Available
Foshan First People's Hospital
Foshan, Guangdong
ChinaSite Not Available
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
ChinaSite Not Available
Henan Provincial People's Hospital
Zhengzhou, Henan
ChinaSite Not Available
The First Affiliated Hospital of Anhui Medical University
Hefei, Jiangsu
ChinaSite Not Available
Nanjing Second Hospital
Nanjing, Jiangsu
ChinaSite Not Available
The First Hospital of Jilin University
Ch'ang-ch'un, Jilin
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
ChinaSite Not Available
Shanghai Tongren Hospital
Shanghai, Shanghai
ChinaSite Not Available
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai
ChinaSite Not Available
Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang
ChinaSite Not Available
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
ChinaSite Not Available
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