NCT02466516

Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3

A Phase 2, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	SEL	SEL tablet administered orally once daily
BIOLOGICAL	SIM	Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly

Timeline

• Start date: 2015-06-08
• Primary completion: 2016-10-11
• Completion: 2016-10-11
• First posted: 2015-06-09
• Last updated: 2019-06-26
• Results posted: 2019-06-26

Locations

28 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study