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

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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
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Bellevue, Nebraska 68123
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Boston, Massachusetts 02118
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Caba, Buenos Aires
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Catonsville, Maryland 21228
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Cincinnati, Ohio 45229
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Coronado, California 92118
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Dallas, Texas 75216
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Detroit, Michigan 48202
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Georgia, Georgia 30607
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Hermitage Nashville, Tennessee 37076
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Houston, Texas 77030
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Lakewood Ranch, Florida 34211
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Lonetree, Colorado 80124
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Los Angeles, California 90095
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Marietta, Georgia 30060
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Minneapolis, Minnesota 55402
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Morehead City, North Carolina 28557
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Norfolk, Virginia 23507
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North Little Rock, Arkansas 72117
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Orlando, Florida 32806
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Pasadena, California 91105
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Pensacola, Florida 32504
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Philadelphia, Pennsylvania 19102
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Richmond, Virginia 23249
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San Diego, California 92123
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Worcester, Massachusetts 01665
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