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NCT02466516 · ClinicalTrials.gov registry record · Phase 2

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 study of Non-alcoholic Steatohepatitis (NASH), sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
72
Enrollment target
20
Study locations

NCT02466516 is a Phase 2 study of Non-alcoholic Steatohepatitis (NASH) that has completed, run by Gilead Sciences. The registered enrollment target is 72 participants, below the 163-participant average among 8 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT02466516, a Phase 2 study of Non-alcoholic Steatohepatitis (NASH), has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
72 participants
Enrollment target
20
Study locations

Study 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 Studied

Non-alcoholic Steatohepatitis (NASH)

Interventions

  • DRUG SEL
  • BIOLOGICAL SIM

Study Locations (20)

Texas

  • Texas Clinical Research Institute - Arlington
  • Methodist Dallas Medical Center - Dallas
  • CHI St. Luke's Health Baylor College of Medicine - Houston
  • Brooke Army Medical Center Ft. Sam - Houston
  • Digestive Research Center - Live Oak
  • American Research Corporation at Texas Liver Institute - San Antonio

California

  • Stanford University Medical Center - Palo Alto
  • University of California San Diego - San Diego
  • University of California San Francisco - San Francisco

Maryland

  • Mercy Medical Center - Baltimore
  • Walter Reed National Military Medical Center - Bethesda

Pennsylvania

  • Hospital of the University of Pennsylvania - Philadelphia
  • University of Pittsburg Medical Center - Pittsburgh

Colorado

  • University of Colorado Denver - Aurora

Illinois

  • Northwestern University - Chicago

Indiana

  • Indiana University School of Medicine - Indianapolis

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2015-06-08
Est. Completion 2016-10-11
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02466516

The ClinicalTrials.gov registry entry for NCT02466516 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 163-participant average among 8 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (56% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-alcoholic Steatohepatitis (NASH) appearing as the primary indexed condition, and to 2 interventions - of which SEL is the first listed.

NCT02466516 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Texas, California, Maryland.

Frequently Asked Questions

What is clinical trial NCT02466516 about?

NCT02466516 is a clinical study titled "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". 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 s...

What is the current status of trial NCT02466516?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2015-06-08. Estimated completion is 2016-10-11.

What conditions does trial NCT02466516 study?

This clinical trial studies the following conditions: Non-alcoholic Steatohepatitis (NASH).

What interventions are being tested in trial NCT02466516?

The interventions under investigation include: SEL (DRUG), SIM (BIOLOGICAL).

Who is sponsoring clinical trial NCT02466516?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02466516 being conducted?

This trial has 20 study locations across California, Colorado, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.