A Phase II Clinical Trial of Chiglitazar for NASH

Last updated: May 24, 2024
Sponsor: Chipscreen Biosciences, Ltd.
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

chiglitazar sodium tablets

Placebo

Clinical Study ID

NCT05193916
CGZ203
CINAR
  • Ages 18-75
  • All Genders

Study Summary

The study is to evaluate the efficacy and safety of chiglitazar monotherapy in patients with non-clcoholic steatohepatitis (NASH).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Before any evaluation, an informed consent form voluntarily signed by the patientmust 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

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

  1. Existing other liver diseases or history of liver diseases

  2. History of transient ischemic attack or cerebrovascular accident;

  3. 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 ;

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

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

  6. Liver transplantation history or planned liver transplantation;

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

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

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

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

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

  12. With MRI scan contraindications;

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

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

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

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

  17. History of drug abuse in 12 months;

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

  19. Drugs that may cause liver damage for more than 2 weeks within 1 year beforescreening;

  20. 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;

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

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

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

  24. Platelet < 100×10^9 /L ;

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

  26. Pregnant or breastfeeding women.

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: chiglitazar sodium tablets
Phase: 2
Study Start date:
March 21, 2022
Estimated Completion Date:
January 02, 2024

Study 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) and insulin resistance. The efficacy and safety of chiglitazar tablets 48mg and 64mg will be compared with placebo in the 18-week-treament.

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Beijing Youan Hospital, Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing
    China

    Site Not Available

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu
    China

    Site Not Available

  • Foshan First People's Hospital

    Foshan, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Jiangsu
    China

    Site Not Available

  • Nanjing Second Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • The First Hospital of Jilin University

    Ch'ang-ch'un, Jilin
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi
    China

    Site Not Available

  • Shanghai Tongren Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai
    China

    Site Not Available

  • Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang
    China

    Site Not Available

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

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