Polyene Phosphatidyl choline: Polyene Phosphatidyl choline 456mg/three times a day
Study summary
This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Men and women aged at least 18 years and under 75 years (inclusive) at the time of obtaining consent.
2. Participants must be diagnosed as T2DM and HbA1c ≤ 9.5% at time of screening.
3. Participants must take Fibroscan examination with the result of CAP ≥ 238 dB/m and LSM\>8.5 kPa.
4. Diagnosis of MASH by liver biopsy, with NAFLD Activity Score (NAS) ≥4 with ≥1 point for each component, and fibrosis stage 1b or more over according to the NASH Clinical Research Network (CRN) scoring system. (or liver biopsy not more than 6 months prior to screening)
5. Stable body weight (≤10% body weight change) for at least 3 months.
6. Possess good understanding and behavior and be able to take the medication daily as required by the trial.
7. Willing to sign the informed consent.
Exclusion Criteria:
1. Alcohol consumption \>20g ethyl alcohol/day for women and \>40g ethyl alcohol/day for men.
2. Evidence of other forms of chronic liver disease:
1. Alcoholic liver disease,
2. Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg) or hepatitis B DNA,
3. Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA or positive hepatitis C antibody (anti-HCV),
4. Evidence of autoimmune liver disease as defined by compatible liver histology,
5. Current drug-induced liver disease as defined on the basis of typical exposure and history,
6. Suspected or proven liver cancer,
7. Any other type of liver disease other than MASH.
3. Uncontrolled T2DM defined as HbA1c \>9.5% at time of screening or Type 1 diabetes mellitus (T1DM).
4. Patients with T2DM who have a history of diabetic ketoacidosis, proliferative diabetic retinopathy, diabetic maculopathy or severe non-proliferative diabetic retinopathy that requires acute treatment.
5. Any of the following cardiovascular conditions within 6 months prior to screening:
1. acute myocardial infarction (MI),
2. cerebrovascular accident (stroke),
3. unstable angina,
4. hospitalization due to congestive heart failure (CHF)
5. New York Heart Association Functional Classification IV CHF
6. History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
7. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg).
8. Renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2.
9. Known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect gastrointestinal motility.
10. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).
11. Evidence of untreated hypothyroidism or hyperthyroidism based on clinical or laboratory evaluation.
12. A transplanted organ (corneal transplants allowed) or awaiting an organ transplant.
13. Women of childbearing potential: positive pregnancy test during screening or at randomization or unwillingness to use an effective form of birth control during the trial (at least include one barrier contraceptive method) and breast feeding.
14. Use of drugs associated with hepatic steatosis (e.g., amiodarone, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening.
15. Current use of medication is associated with weight gain, except when on stable dose for at least 3 months prior to screening and remaining on stable dose during the study.
16. Receiving or having received (within 3 months of screening) chronic (\>2 weeks) systemic glucocorticoid therapy.
17. Use of treatment targeting MASH for more than 2 weeks in the 3 months prior to screening (GLP-1 receptor agonists or PPAR pan agonists).
18. Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.
Primary outcome measure(s)
Percentage of participants with resolution of steatohepatitis and no worsening of liver fibrosis — week 72 The definition of resolution of steatohepatitis was based on the following criteria: ballooning=0, inflammation=0,1 and any level of steatosis in NAS
Trial sites (17)
Facility
City
Region
Status
Ditan Hospital of integrated traditional Chinese and Western Medicine Center
Beijing
Beijing Municipality
Not Yet Recruiting
Southwest Hospital of Third Military Medical University
Chongqing
Chongqing Municipality
Not Yet Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Fujian
Not Yet Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Not Yet Recruiting
Southern Hospital
Guangzhou
Guangdong
Not Yet Recruiting
Wuhan Union Hospital of Huazhong University of Science and Technology
Wuhan
Hebei
Not Yet Recruiting
Taihe Hospital
Shiyan
Hubei
Not Yet Recruiting
Xiangya hospital of Central South University
Changsha
Hunan
Not Yet Recruiting
The First Affiliated Hospital of Jilin University
Changchun
Jilin
Not Yet Recruiting
Renji hospital of Shanghai Jiao Tong University School of Medical
Shanghai
Shanghai Municipality
Not Yet Recruiting
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai
Shanghai Municipality
Not Yet Recruiting
Shanghai Public Health Clinical Center
Shanghai
Shanghai Municipality
Not Yet Recruiting
Shanghai Punan Hospital of Pudong New District (Punan Branch of Renji Hospital, Shanghai Jiaotong University School of Medicine)
Shanghai
Shanghai Municipality
Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an
Shanxi
Not Yet Recruiting
Tianjin Second People's Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
The First Teaching Hospital of Xinjiang Medical University
Ürümqi
Xinjiang
Not Yet Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou
Zhejiang
Not Yet Recruiting
More Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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