Chiglitazar for MASH and Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study enrolling adults with biopsy-confirmed MASH and fibrosis stage F1b or higher. Participants will receive either chiglitazar 48 mg daily or placebo for 72 weeks, in addition to background therapy with vitamin E and polyene phosphatidylcholine. The primary goal is to see if treatment leads to resolution of steatohepatitis without worsening liver fibrosis, with secondary goals including improvement in fibrosis stage and metabolic and safety outcomes. Eligible participants must have T2DM, specific liver stiffness and steatosis measurements, and stable body weight, among other criteria. The study is sponsored by Shanghai Jiao Tong University School of Medicine with collaboration from Chipscreen Biosciences, conducted at several Chinese centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Punan Hospital of Pudong New District (Punan Branch of Renji Hospital, Shanghai Jiaotong University School of Medicine)
  Shanghai, Shanghai Municipality, China Recruiting
• Ditan Hospital of integrated traditional Chinese and Western Medicine Center
  Beijing, Beijing Municipality, China Not yet recruiting
• Southwest Hospital of Third Military Medical University
  Chongqing, Chongqing Municipality, China Not yet recruiting
• The First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Not yet recruiting
• The Third Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Not yet recruiting
• Southern Hospital
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Hai Li, professor — Shanghai Punan Hospital of Pudong New District (Punan Branch of Renji Hospital, Shanghai Jiaotong University School of Medicine)
• Study coordinator: Hai Li, professor
• Email: haili_17@126.com
• Phone: +86 13818525494

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.