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NCT07303803
A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus
Conditions: MASH - Metabolic Dysfunction-Associated Steatohepatitis, T2DM (Type 2 Diabetes Mellitus)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 300
Sponsor: Shanghai Jiao Tong University School of Medicine
Location: Ditan Hospital of integrated traditional Chinese and Western Medicine Center Beijing Beijing Municipality
Summary
This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.
Eligibility Criteria
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) \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.
Source: ClinicalTrials.gov (NCT07303803). StuddyBuddy aggregates publicly available trial information.
