Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)



Status:Terminated
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:3/29/2019
Start Date:December 5, 2012
End Date:December 29, 2016

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

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like Molecule 2 (LOXL2), in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

The primary objective of this study is to evaluate whether SIM (formerly referred to as
GS-6624) is effective at preventing the histologic progression of liver fibrosis and the
clinical progression to cirrhosis in participants with NASH.

It will consist of 2 phases:

- Randomized Double-Blind Phase

- Open-Label Phase (optional)


Key Inclusion Criteria:

- Adults with chronic liver disease due to NASH defined as macrovesicular steatosis
involving > 5% of hepatocytes on a liver biopsy with associated lobular inflammation

- Stage 3-4 fibrosis by Ishak score on a liver biopsy

- Exclusion of other causes of liver disease including viral hepatitis and alcoholic
liver disease

- Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x
Central Laboratory Upper Limit of Normal (clULN)

- Must have serum creatinine < 2.0 mg/dL

- A negative serum pregnancy test is required for females of childbearing potential

- All sexually active females of childbearing potential must agree to use a protocol
recommended method of contraception during intercourse throughout the study and for 90
days following the last dose of study medication

- Lactating females must agree to discontinue nursing before starting study treatment

- Males, if not vasectomized, are required to use barrier contraception (condom plus
spermicide) during heterosexual intercourse from the screening through the study
completion and for 90 days following the last dose of study drug.

Key Exclusion Criteria:

- Pregnant or breast feeding

- Cirrhosis of the liver

- Any history of hepatic decompensation including ascites, hepatic encephalopathy or
variceal bleeding

- Weight reduction surgery in the past 5 years

- Positive for hepatitis C virus (HCV) RNA

- Positive for HBsAg

- Alcohol consumption greater than 21oz/week for males or 14oz/week for females

- Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at
screening.

- Clinically significant cardiac disease

- History of malignancy, other than non-melanomatous skin cancer, within 5 years prior
to screening

- Major surgical procedure within 30 days prior to screening or the presence of an open
wound

- Known hypersensitivity to the investigation product or any of its formulation
excipients

- History of bleeding diathesis within 6 months of screening

- Unavailable for follow-up assessment or concern for individual's compliance with the
protocol procedures;

- Participation in an investigational trial of a drug or device within 30 days prior to
screening

- BMI < 18 kg/m^2

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
42
sites
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Arlington, Texas 76012
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Brussels, 1070
?
mi
from
Brussels,
Click here to add this to my saved trials
Buffalo, New York 14230
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
?
mi
from
Burlington, MA
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clive, Iowa 50325
?
mi
from
Clive, IA
Click here to add this to my saved trials
Coronado, California 92118
?
mi
from
Coronado, CA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport News, Virginia 23602
?
mi
from
Newport News, VA
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Providence, Rhode Island 02905
?
mi
from
Providence, RI
Click here to add this to my saved trials
Richmond, Virginia 23603
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
3635 Vista at Grand Ave.
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Paul, Minnesota 55114
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
San Antonio, Texas 78212
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
?
mi
from
Seattle, WA
Click here to add this to my saved trials