Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:August 1, 2016
End Date:April 3, 2020
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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

A Randomized, Double-blind, Placebo Controlled, 3- Part, Adaptive Design, Multicenter Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH): FLIGHT-FXR

The purpose of the study is to assess the effects of different doses of tropifexor (LJN452)
with respect to safety, tolerability, and on markers of liver inflammation in patients with
NASH


Inclusion Criteria:

- male/female patients, 18 years or older

- written informed consent

- Part A and B patients : presence of NASH by histological evidence (liver biopsy
obtained 2 years or less prior to randomization) with fibrosis level of F1, F2 or F3
(fibrosis in the absence of cirrhosis) and no diagnosis of chronic liver disease and
elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT,
BMI and diagnosis of Type 2 diabetes mellitus (DM)

- Part C patients: presence of NASH by histological evidence (liver biopsy obtained
during the Screening period or 6 months or less prior to randomization) with fibrosis
level of F2 or F3 and no diagnosis of chronic liver disease

And ( All Parts):

- ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)

- Liver fat equal to or higher than 10% by MRI

Exclusion Criteria:

- previous exposure to OCA

- patients taking prohibited medications

- patients taking the following medicines UNLESS on a stable dose (within 25% of
baseline dose) for at least 1 month before randomization: (for Part C patients, dose
must be stable for at least 1 month prior to biopsy through Screening : anti- diabetic
medications, insulin, beta-blockers, thiazide diuretics, fibrates, statins, niacin,
ezetimibe, vitamin E (if doses > 200 IU/day; doses > 800 IU/day are prohibited),
thyroid hormone, psychotropic medications, estrogen or estrogen containing birth
control

- pregnant or nursing (lactating) women

- current or history of significant alcohol consumption for a period of more than 3
consecutive months within 1 year prior to screening

- uncontrolled diabetes mellitus

- new use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or
dulaglutide within 3 months of screening

- presence of cirrhosis

- hepatic decompensation or severe liver impairment

- previous diagnosis of other forms of chronic liver disease

- patients with contraindications to MRI imaging
We found this trial at
32
sites
Coronado, California 92118
?
mi
from
Coronado, CA
Click here to add this to my saved trials
Bellevue, Nebraska 68123
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Caba, Buenos Aires
?
mi
from
Caba,
Click here to add this to my saved trials
Catonsville, Maryland 21228
?
mi
from
Catonsville, MD
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Georgia, Georgia 30607
?
mi
from
Georgia, GA
Click here to add this to my saved trials
Hermitage Nashville, Tennessee 37076
?
mi
from
Hermitage Nashville, TN
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
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Lakewood Ranch, Florida 34211
?
mi
from
Lakewood Ranch, FL
Click here to add this to my saved trials
Lonetree, Colorado 80124
?
mi
from
Lonetree, CO
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Madison, Alabama 35758
?
mi
from
Madison, AL
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Morehead City, North Carolina 28557
?
mi
from
Morehead City, NC
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
North Little Rock, Arkansas 72117
?
mi
from
North Little Rock, AR
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Pasadena, California 91105
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Pensacola, Florida 32504
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Rialto, California
?
mi
from
Rialto, CA
Click here to add this to my saved trials
Richmond, Virginia 23249
?
mi
from
Richmond, VA
Click here to add this to my saved trials
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94121
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Worcester, Massachusetts 01665
?
mi
from
Worcester, MA
Click here to add this to my saved trials