Conditions: Non-Alcoholic Steatohepatitis (NASH)
Keywords: GS-4997 Non-alcoholic fatty liver disease (NAFLD) Fibrosis Simtuzumab (SIM) Apoptosis signal-regulating kinase 1 ASK1 inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 72
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib \[SEL\]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.

Detailed description:

Arms:
arm 1: Selonsertib (SEL) 6 mg for 24 weeks. arm 2: SEL 18 mg for 24 weeks. arm 3: SEL 6 mg plus SIM 125 mg for 24 weeks. arm 4: SEL 18 mg plus SIM 125 mg for 24 weeks. arm 5: SIM 125 mg for 24 weeks.

Interventions: intervention 1: SEL intervention 2: SIM
Intervention descriptions: intervention 1: SEL tablet administered orally once daily intervention 2: Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly

Protocol document: