Patients and study design
NAFLD
In this phase Ib/IIa randomized, double-blinded, placebo-controlled, multiple-dose trial, a total of 95 patients with NAFLD were recruited and screened for eligibility in the First Hospital of Jilin University (Changchun, Jilin, China) and another two medical centers in China, including Nanfang Hospital, Nanfang Medical University (Guangzhou, Guangdong, China) and Beijing Friendship Hospital, Capital Medical University (Beijing, China) between June 2020 and June 2021, and the last patient completed follow-up in August 2021. Patients were diagnosed by liver biopsy with a NAFLD activity score (NAS) of 4 or more, or by clinical features of NAFLD that fulfilled the following two criteria: (1) Alanine aminotransferase (ALT) ≥ 1.5×ULN (male 75 U/L, female 60 U/L) for two examinations with an interval at least 7 days; (2) Body-mass index (BMI) ≥ 25 kg/m