Loading clinical trials...

Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)

NCT02854605•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meets the following conditions:
•* A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
•* Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis
•* Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kilopascal (kPa) OR
•* A historical liver biopsy within 12 months of screening consistent with NASH with fibrosis, but not cirrhosis, and
•* No documented weight loss \> 5% between the date of the liver biopsy and screening.
•Platelet count ≥ 150,000/mm\^3
•Albumin ≥ 3.3 g/dL
•Serum creatinine ≤ upper limit of normal (ULN)

Exclusion Criteria

•Pregnant or lactating females
•Alanine aminotransferase (ALT) \> 5x upper limit of the normal range (ULN)
•Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
•Cirrhosis of the liver
•* Prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding
•Body mass index (BMI) \< 18 kg/m\^2
•Uncontrolled diabetes mellitus (hemoglobin A1c \> 9% at screening)
•International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
•Total bilirubin \> 1 x ULN, except with diagnosis of Gilbert's syndrome

Locations (37)

Ruane Clinical Research Group Inc.

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Inland Empire Liver Foundation

Rialto, California, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Northwestern Memorial Hospital, Clinical Research Unit

Chicago, Illinois, United States

Crescent Clinical Research Center, LLC

Metairie, Louisiana, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Kansas City Research Institute

Kansas City, Missouri, United States

Concorde Medical Group, PLLC

New York, New York, United States

Key Dates

Start Date

October 26, 2016

Primary Completion Date

January 9, 2018

Completion Date

January 9, 2018

Last Updated

January 29, 2019

Enrollment

140

ACTUAL participants

Conditions

Nonalcoholic Steatohepatitis (NASH)

Interventions

GS-9674

DRUG

Placebo to match GS-9674

DRUG

To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects

NCT06216041

Nonalcoholic Steatohepatitis (NASH)

View study

SUSPENDEDPHASE3

A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)

NCT04104321

Nonalcoholic Steatohepatitis (NASH)

View study

COMPLETEDPHASE2

Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)

Inclusion Criteria

Exclusion Criteria

To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects

A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)

Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)

The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects

Tesamorelin Effects on Liver Fat and Histology in HIV