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

Primary Purpose

Non-alcoholic Steatohepatitis (NASH)

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Tropifexor (LJN452)

Placebo

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis (NASH) focused on measuring LJN452, non-alcoholic steatohepatitis, NASH, phase 2, adaptive design, randomized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

LJN452 10 μg

LJN452 30 μg

LJN452 60 μg

LJN452 90 μg

Placebo A+ B

LJN452 140 μg

LJN452 200 μg

Placebo C

Arm Description

Tropifexor (LJN452) Part A

Tropifezor (LJN452) Parts A + B

Tropifexor (LJN452) Parts A + B

Placebo Parts A + B

Tropifexor (LJN452) Part C

Tropifexor (LJN452) Part B

Placebo Part C

Outcomes

Primary Outcome Measures

Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE)

Number of Nonalcoholic steatohepatitis (NASH) patients with TEAEs

Change in Transaminase Levels (ALT)

The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. High levels of ALT may indicate liver damage. Normal range for ALT is typically 10 to 45 U/L or so (varies a little by age and gender). Elevation of these values indicate more liver inflammation/damage. ALT elevation is not unexpected in this patient population Dose relationship of tropifexor (LJN452) on ALT marker of hepatic inflammation in NASH from baseline to week 12 Summary statistics of change in ALT from baseline to EOT by treatment

Change in Aspartate Transaminase (AST)

To determine the dose relationship of tropifexor (LJN452) on markers of hepatic inflammation (AST) in NASH from baseline to Week 12 The alanine aminotransferase (AST) test is a blood test that checks for liver damage. High levels of AST may indicate liver damage. Normal range for AST is typically 10 to 45 U/L or so (varies a little by age and gender). Elevation of these values indicate more liver inflammation/damage AST elevation is not unexpected in this patient population The aspartate aminotransferase (AST) test is a blood test that checks for liver damage. Higher levels indicate more possible liver damage Summary statistics of change in AST from baseline up to end of treatment (EOT)

Change From Baseline in % of Fat in the Liver Assessed Using Magnetic Resonance Imaging (MRI)

Repeated measures analysis: Relative change in percentage of fat in the liver assessed using MRI from baseline by visit up to EOT (Full analysis set)

Secondary Outcome Measures

Change From Baseline in Weight

Repeated measures for LS mean change in weight after 12 weeks of treatment

Change in Body Mass Index (BMI)

Repeated measures for the LS mean change in BMI after 12 weeks of treatment. Body mass index (BMI) is a measure of body fat based on height and weight

Change From Baseline in Waist to Hip (WTH) Ratio

The LS mean change in waist to hip ratio after 12 weeks of treatment

Change From Baseline in Biomarker FGF19

Dose-response relationship of tropifexor (LJN452) on FGF19 over time, a marker of FXR target engagement in the gut. ANCOVA: Ratio of FGF19 (pg/mL) post-dose to pre-dose at Week 6 Value at 6 weeks minus value at baseline

Change From Baseline in Biomarker C4

Dose-response relationship of LJN452 on C4, a marker of hepatic target engagement at 4 hours post dose C4 (ng/mL): Summary statistics by treatment and visit

Change From Baseline on Markers of Liver Fibrosis, Fibroscan

Dose-response relationship of tropifexor (LJN452) on markers of liver fibrosis commonly available such as Fibroscan® Liver stiffness (kPa): Summary statistics by treatment and visit FibroScan is a specialized ultrasound machine for measuring fibrosis (scarring) in the liver Scores range from 0-4 with zero being no liver scarring and 4 being advanced liver scarring (cirrhosis)

Change From Baseline on Markers of Liver Fibrosis Panel (ELF) Score

ANCOVA: LS Mean Change in Enhanced liver fibrosis panel (ELF) score from baseline by visit up to EOT. The total ELF score reference range calculated non-parametrically is 6.72 (90% CI 6.58-6.84) to 9.79 (90% CI 9.45-10.01); Journal of Hepatology 2013 vol. 59 j 236-242. Enhanced liver fibrosis Test (ELF) panel: the following was assessed: hyaluronic acid (HA), tissue inhibitor of metalloproteinases (TIMP-1), and amino-terminal pro-peptide of procollagen type III (PIIINP). The Enhanced Liver Fibrosis score is a linear combination of TIMP-1, PIIINP, and HA with the following formula: ELF score = 2.494+0.846 x ln(HA) + 0.735 x ln (PIIINP) + 0.391 x ln (TIMP-1).

Change From Baseline on Markers of Liver Fibrosis, Fibrotest (Parts A+B)

Fibrosis biomarker test, originally called Fibrotest®/ Fibrosure®, is combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT. The coefficient for the score is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e^-z). Calculated scores range from 0.00 (no fibrosis) to 1.00 (severe fibrosis or cirrhosis) (See Part C in separate outcomes that follows)

Change From Baseline on Markers of Liver Fibrosis, Fibrotest, (Part C)

Change From Baseline on Gamma-glutamyl Transferase (GGT)

Summary statistics of change in GGT (IU/L) from baseline by visit up to EoT

Change From Baseline on Fasting Lipid Profile

Repeated measures analysis: LS geometric mean ratio of fasting lipids to baseline by visit up to EOT

Itch Based on a Visual Analog Scale (VAS) Rating Scale

Repeated measures analysis: Change in VAS for Itch from baseline by visit up to EoT VAS score 0 = no disease; and 9 is severely advanced disease

Pre-dose Trough Concentration (Ctrough) of LJN452

Pre-dose Trough Concentration (Ctrough) of tropifexor (LJN452)

C2h (Steady-state Drug Levels 2 Hours Postdose) of LJN452

Summary C2h of tropifexor (LJN452)

Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening of Steatohepatitis (Part C) - Total Score

Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)

Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening - FDA

Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)

Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening - EMA

Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)

Biopsy-based Response at Week 48 Compared to Baseline: Difference Between Treatment Groups (Part C) - Resolution of Steatohepatitis (Diagnostic Category)

Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)

Biopsy-based Response at Week 48 Compared to Baseline: Difference Between Treatment Groups (Part C) - Resolution of Steatohepatitis (FDA, EMA)

Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)

Full Information

NCT ID

NCT02855164

First Posted

July 20, 2016

Last Updated

August 11, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02855164

Brief Title

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

Acronym

FLIGHT-FXR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Terminated

Study Start Date

August 1, 2016 (Actual)

Primary Completion Date

April 6, 2020 (Actual)

Study Completion Date

April 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study was 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

Detailed Description

Part A In Part A, 77 subjects were randomized at baseline to receive tropifexor (10 μg, 30 μg, 60 μg or 90 μg) or placebo (Arms A, B, C, D and E) for 12 weeks. After ≥ 90% of the subjects from Part A completed 8 weeks of treatment, the first interim analysis of all Part A data was performed and the Data Monitoring Committee (DMC) recommended evaluation of 90 μg tropifexor (safe andefficacious) in Part B. The treatment arms of Part A were completed through Week 16 without adaptation. Part B Randomization for Part B was started after the DMC recommendations on the dose to be used in Part B were implemented by the sponsor. As planned in the study protocol, since the first interim analysis selected one active dose (90 μg) to be tested in Part B, one of the other originally planned active treatment arms (60 μg) was included with a smaller sample size to confirm the earlier findings of this dose observed in Part A. Therefore, in Part B, 121 subjects, were randomized at baseline to receive tropifexor (90 μg and 60 μg) or placebo (Arms F, G and H) for 12 weeks. Part C was introduced as a result of the DMC recommendation to pursue doses > 90 μg. Randomization in Part C started once the Part B randomization was completed. In Part C, 152 subjects were randomized at baseline to receive 140 μg or 200 μg tropifexor or placebo (Arms I, J and K) for 48 weeks. One patient was treated at 2 sites but is still only one patient. 350 total enrollment, and not 351.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-alcoholic Steatohepatitis (NASH)

Keywords

LJN452, non-alcoholic steatohepatitis, NASH, phase 2, adaptive design, randomized

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

This was a randomized, double-blind, placebo-controlled, multicenter, parallel-group, dose finding, 3-part (Parts A, B, and C), adaptive design study to assess the safety, tolerability, and efficacy of six doses of tropifexor as compared to placebo in subjects with NASH. Each study part had a screening period followed by a double-blind, randomized, treatment period, and a post-treatment follow-up period. This study was extended based on safety and efficacy results in Part A and available long-term toxicology coverage; Part C was added to explore 48 weeks of treatment at higher doses with paired biopsies in F2/3 NASH patients.

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

350 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LJN452 10 μg

Arm Type

Experimental

Arm Description

Tropifexor (LJN452) Part A

Arm Title

LJN452 30 μg

Arm Type

Experimental

Arm Description

Tropifexor (LJN452) Part A

Arm Title

LJN452 60 μg

Arm Type

Experimental

Arm Description

Tropifezor (LJN452) Parts A + B

Arm Title

LJN452 90 μg

Arm Type

Experimental

Arm Description

Tropifexor (LJN452) Parts A + B

Arm Title

Placebo A+ B

Arm Type

Placebo Comparator

Arm Description

Placebo Parts A + B

Arm Title

LJN452 140 μg

Arm Type

Experimental

Arm Description

Tropifexor (LJN452) Part C

Arm Title

LJN452 200 μg

Arm Type

Experimental

Arm Description

Tropifexor (LJN452) Part B

Arm Title

Placebo C

Arm Type

Placebo Comparator

Arm Description

Placebo Part C

Intervention Type

Drug

Intervention Name(s)

Tropifexor (LJN452)

Intervention Description

Comparison of different doses of drug

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Comparator

Primary Outcome Measure Information:

Title

Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE)

Description

Number of Nonalcoholic steatohepatitis (NASH) patients with TEAEs

Time Frame

End of Treatment (EoT): For Parts A&B, EoT was Week 12 (Primary Outcome Measure). For Part C, EoT was Week 48 (Secondary Outcome Measure)

Title

Change in Transaminase Levels (ALT)

Description

Time Frame

End of Treatment (EoT): For Parts A&B, EoT was Week 12 (Primary Outcome Measure). For Part C, EoT was Week 48 (Secondary Outcome Measure)

Title

Change in Aspartate Transaminase (AST)

Description

Time Frame

End of Treatment (EoT): For Parts A&B, EoT was Week 12 (Primary Outcome Measure). For Part C, EoT was Week 48 (Secondary Outcome Measure)

Title

Change From Baseline in % of Fat in the Liver Assessed Using Magnetic Resonance Imaging (MRI)

Description

Repeated measures analysis: Relative change in percentage of fat in the liver assessed using MRI from baseline by visit up to EOT (Full analysis set)

Time Frame

End of Treatment (EoT): For Parts A&B, EoT was Week 12 (Primary Outcome Measure). For Part C, EoT was Week 48 (Secondary Outcome Measure)

Secondary Outcome Measure Information:

Title

Change From Baseline in Weight

Description

Repeated measures for LS mean change in weight after 12 weeks of treatment

Time Frame

48 weeks

Title

Change in Body Mass Index (BMI)

Description

Repeated measures for the LS mean change in BMI after 12 weeks of treatment. Body mass index (BMI) is a measure of body fat based on height and weight

Time Frame

12 weeks

Title

Change From Baseline in Waist to Hip (WTH) Ratio

Description

The LS mean change in waist to hip ratio after 12 weeks of treatment

Time Frame

12 weeks

Title

Change From Baseline in Biomarker FGF19

Description

Time Frame

baseline, week 6

Title

Change From Baseline in Biomarker C4

Description

Dose-response relationship of LJN452 on C4, a marker of hepatic target engagement at 4 hours post dose C4 (ng/mL): Summary statistics by treatment and visit

Time Frame

Week 6, 4 hours post dose

Title

Change From Baseline on Markers of Liver Fibrosis, Fibroscan

Description

Time Frame

End of Treatment (EoT): For Parts A&B, EoT was Week 12. For Part C, EoT was Week 48

Title

Change From Baseline on Markers of Liver Fibrosis Panel (ELF) Score

Description

Time Frame

End of Treatment (EoT): For Parts A&B, EoT was Week 12. For Part C, EoT was Week 48

Title

Change From Baseline on Markers of Liver Fibrosis, Fibrotest (Parts A+B)

Description

Time Frame

End of Treatment (EoT):12 weeks

Title

Change From Baseline on Markers of Liver Fibrosis, Fibrotest, (Part C)

Description

Time Frame

End of Treatment (EoT) was 48 weeks

Title

Change From Baseline on Gamma-glutamyl Transferase (GGT)

Description

Summary statistics of change in GGT (IU/L) from baseline by visit up to EoT

Time Frame

EoT for Parts A+B=12 weeks; EoT for Part C = 48 weeks

Title

Change From Baseline on Fasting Lipid Profile

Description

Repeated measures analysis: LS geometric mean ratio of fasting lipids to baseline by visit up to EOT

Time Frame

End of Treatment (EoT): For Parts A&B, EoT was Week 12. For Part C, EoT was Week 48

Title

Itch Based on a Visual Analog Scale (VAS) Rating Scale

Description

Repeated measures analysis: Change in VAS for Itch from baseline by visit up to EoT VAS score 0 = no disease; and 9 is severely advanced disease

Time Frame

EoT for Parts A+B=12 weeks; EoT for Part C = 48 weeks

Title

Pre-dose Trough Concentration (Ctrough) of LJN452

Description

Pre-dose Trough Concentration (Ctrough) of tropifexor (LJN452)

Time Frame

In Parts A and B, LJN452 Ctrough was measured on Study Days 7, 14, 28, 42, 56, and 84. In Part C LJN452 Ctrough was measured on Study Days 42, 84, 168, 280 and 336

Title

C2h (Steady-state Drug Levels 2 Hours Postdose) of LJN452

Description

Summary C2h of tropifexor (LJN452)

Time Frame

Days 7 and 14 (10 and 30μg LJN452 C2h was not measured day 14)

Title

Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening of Steatohepatitis (Part C) - Total Score

Description

Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)

Time Frame

EoT (Week 48)

Title

Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening - FDA

Description

Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)

Time Frame

EoT (Week 48)

Title

Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening - EMA

Description

Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)

Time Frame

EoT (Week 48)

Title

Biopsy-based Response at Week 48 Compared to Baseline: Difference Between Treatment Groups (Part C) - Resolution of Steatohepatitis (Diagnostic Category)

Description

Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)

Time Frame

EoT (Week 48)

Title

Biopsy-based Response at Week 48 Compared to Baseline: Difference Between Treatment Groups (Part C) - Resolution of Steatohepatitis (FDA, EMA)

Description

Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)

Time Frame

EoT (Week 48)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Novartis Investigative Site

City

Madison

State/Province

Alabama

ZIP/Postal Code

35758

Country

United States

Facility Name

Novartis Investigative Site

City

North Little Rock

State/Province

Arkansas

ZIP/Postal Code

72117

Country

United States

Facility Name

Novartis Investigative Site

City

Coronado

State/Province

California

ZIP/Postal Code

92118

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Novartis Investigative Site

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

Novartis Investigative Site

City

Rialto

State/Province

California

ZIP/Postal Code

92377

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92114

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Novartis Investigative Site

City

Lonetree

State/Province

Colorado

ZIP/Postal Code

80124

Country

United States

Facility Name

Novartis Investigative Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33434

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Novartis Investigative Site

City

Lakewood Ranch

State/Province

Florida

ZIP/Postal Code

34211

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Novartis Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Novartis Investigative Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32503

Country

United States

Facility Name

Novartis Investigative Site

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Novartis Investigative Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Novartis Investigative Site

City

Catonsville

State/Province

Maryland

ZIP/Postal Code

21228

Country

United States

Facility Name

Novartis Investigative Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Novartis Investigative Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Novartis Investigative Site

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65109

Country

United States

Facility Name

Novartis Investigative Site

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

Novartis Investigative Site

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Novartis Investigative Site

City

Hermitage

State/Province

Tennessee

ZIP/Postal Code

37076

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75208-2312

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Novartis Investigative Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1120AAC

Country

Argentina

Facility Name

Novartis Investigative Site

City

Kingswood

State/Province

New South Wales

ZIP/Postal Code

2747

Country

Australia

Facility Name

Novartis Investigative Site

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Novartis Investigative Site

City

Chicoutimi

State/Province

Quebec

ZIP/Postal Code

G7H 7K9

Country

Canada

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75651

Country

France

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110070

Country

India

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

ZIP/Postal Code

24128

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Hatsukaichi city

State/Province

Hiroshima

ZIP/Postal Code

738 8503

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

Novartis Investigative Site

City

Saga-city

State/Province

Saga

ZIP/Postal Code

849-8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Izumo-city

State/Province

Shimane

ZIP/Postal Code

693 8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Dongjak Gu

State/Province

Seoul

ZIP/Postal Code

07061

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Busan

ZIP/Postal Code

602739

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Utrecht

ZIP/Postal Code

3584CX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Novartis Investigative Site

City

Banska Bystrica

ZIP/Postal Code

97517

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

82606

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

85101

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Kaoshiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Keelung City

ZIP/Postal Code

20401

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

35779659

Citation

Naoumov NV, Brees D, Loeffler J, Chng E, Ren Y, Lopez P, Tai D, Lamle S, Sanyal AJ. Digital pathology with artificial intelligence analyses provides greater insights into treatment-induced fibrosis regression in NASH. J Hepatol. 2022 Nov;77(5):1399-1409. doi: 10.1016/j.jhep.2022.06.018. Epub 2022 Jun 30.

Results Reference

derived

Links:

URL

https://clinicaltrials.gov/ct2/show/NCT02913105?term=NASH+novartis&rank=2

Description

A Randomized, Patient and Investigator Blinded, Placebo Controlled, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With Non-alcoholic Steatohepatitis (NASH)

Learn more about this trial

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

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

Non-alcoholic Steatohepatitis (NASH)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial