Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2022-03-21
2024-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Chiglitazar low dose
3 tablets of drug and 1 tablet of placebo p.o. per day
chiglitazar sodium tablets
the drugs will be given orally once a day
Chiglitazar high dose
4 tablets p.o. per day
chiglitazar sodium tablets
the drugs will be given orally once a day
control group
4 placebo tablets p.o. per day
Placebo
no active drug contained
Interventions
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chiglitazar sodium tablets
the drugs will be given orally once a day
Placebo
no active drug contained
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Chipscreen Biosciences, Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Foshan First People's Hospital
Foshan, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Jiangsu, China
Nanjing Second Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Ch’ang-ch’un, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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CINAR
Identifier Type: OTHER
Identifier Source: secondary_id
CGZ203
Identifier Type: -
Identifier Source: org_study_id
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