Completed PHASE2 INTERVENTIONAL 5-arm 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

Sponsor: Gilead Sciences

Conditions Non-Alcoholic Steatohepatitis (NASH)

Interventions SEL SIM

Updated 7 times since 2017 Last updated: May 31, 2019 Started: Jun 8, 2015 Primary completion: Oct 11, 2016 Completion: Oct 11, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Non-Alcoholic Steatohepatitis (NASH) and is currently completed. Gilead Sciences leads this study, which shows 7 recorded versions since 2015 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jul 2019 — Jan 2021 [monthly]

Completed PHASE2
Jun 2018 — Jul 2019 [monthly]

Completed PHASE2

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Jun 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Gilead Sciences

Data source: Gilead Sciences

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Arlington, United States , Aurora, United States , Baltimore, United States , Bethesda, United States , Boston, United States , Calgary, Canada , Charlottesville, United States , Chicago, United States , Dallas, United States , Durham, United States and 16 more locations