This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.
Men and women aged at least 18 years and under 75 years (inclusive) at the time of obtaining consent.
Participants must be diagnosed as T2DM and HbA1c ≤ 9.5% at time of screening.
Participants must take Fibroscan examination with the result of CAP ≥ 238 dB/m and LSM>8.5 kPa.
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)
Alcohol consumption >20g ethyl alcohol/day for women and >40g ethyl alcohol/day for men.
Alcoholic liver disease,
Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg) or hepatitis B DNA,
Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA or positive hepatitis C antibody (anti-HCV),
Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Punan Hospital of Pudong New District
Sponsor institution
Chipscreen Biosciences, Ltd.
Collaborator