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



Status:Completed
Conditions:Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:1/31/2019
Start Date:October 26, 2016
End Date:January 9, 2018

Use our guide to learn which trials are right for you!

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

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


Key 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)

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
27
sites
Nashville, Tennessee 37211
623
mi
from
Nashville, TN
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Arlington, Texas 76012
348
mi
from
Arlington, TX
Click here to add this to my saved trials
Atlanta, Georgia 30342
798
mi
from
Atlanta, GA
Click here to add this to my saved trials
Calgary, Alberta
?
mi
from
Calgary,
Click here to add this to my saved trials
675 North Saint Clair Street
Chicago, Illinois 60611
611
mi
from
Chicago, IL
Click here to add this to my saved trials
801 Monterey Street
Coral Gables, Florida 33134
1318
mi
from
Coral Gables, FL
Click here to add this to my saved trials
341
mi
from
Dallas, TX
Click here to add this to my saved trials
350
mi
from
Dallas, TX
Click here to add this to my saved trials
1051
mi
from
Durham, NC
Click here to add this to my saved trials
1051
mi
from
Durham, NC
Click here to add this to my saved trials
Germantown, Tennessee 38138
481
mi
from
Germantown, TN
Click here to add this to my saved trials
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
572
mi
from
Houston, TX
Click here to add this to my saved trials
425 Volker Boulevard
Kansas City, Missouri 64131
196
mi
from
Kansas City, MO
Click here to add this to my saved trials
Live Oak, Texas 78233
566
mi
from
Live Oak, TX
Click here to add this to my saved trials
5901 West Olympic Boulevard
Los Angeles, California 90036
1174
mi
from
Los Angeles, CA
Click here to add this to my saved trials
3434 Houma Boulevard
Metairie, Louisiana 70006
691
mi
from
Metairie, LA
Click here to add this to my saved trials
778
mi
from
Murray, UT
Click here to add this to my saved trials
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
697
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10016
1288
mi
from
New York, NY
Click here to add this to my saved trials
1108
mi
from
Newport News, VA
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Rialto, California 92377
1120
mi
from
Rialto, CA
Click here to add this to my saved trials
1108
mi
from
Richmond, VA
Click here to add this to my saved trials
Richmond, Virginia 23249
1110
mi
from
Richmond, VA
Click here to add this to my saved trials
575
mi
from
San Antonio, TX
Click here to add this to my saved trials
Seattle, Washington 98104
1410
mi
from
Seattle, WA
Click here to add this to my saved trials