Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)

Inclusion Criteria: * Must be willing and able to participate in the study and provide written informed consent. * Male and female adults ≥18 years of age on the date that written informed consent to take part in the study is provided. * Body mass index (BMI) ≥23 kg/m2 for Asians and ≥25 kg/m2 for other races. * Female subjects must be either: * Not of childbearing potential OR * Women of childbearing potential (WOCBP) must have a negative serum pregnancy (beta-human chorionic gonadotropin \[β-HCG\]) test during Screening, a negative urine pregnancy test within 24 hours before the first dose of study drug on Day 1, and must agree to perform urine home pregnancy tests monthly between study visits. WOCBP must not be breastfeeding, not plan to become pregnant during the study, and must use birth control. * Must have liver stiffness measurement ≥8.5 kPa measured by FibroScan and CAP score measured by FibroScan ≥280 dB/m during the Screening period. * Histologic confirmation of NASH: must have had prior liver biopsy within 180 days before randomization (randomization is within 24 hours of Baseline \[Day1\]) with fibrosis stage F2-F3 and a NAS of ≥4 with at least a score of 1 in each of the following NAS components: steatosis, ballooning degeneration, and lobular inflammation. Exclusion Criteria: * History of harmful alcohol intake for a period of more than 3 consecutive months within 1 year prior to Screening in the judgement of the Investigator. * Active substance abuse. …