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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002692-17 | EudraCT Number |
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Sponsor Decision
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This clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of various single and combination treatments in adult patients with non-alcoholic fatty liver disease (NAFLD) who manifest a non-alcoholic steatohepatitis (NASH)-like biomarker phenotype.
This was a Phase II, non-confirmatory, multicenter, open label, platform study in NAFLD participants with a NASH-like biomarker phenotype to examine the effects of single and combination therapies over 12 weeks of treatment. The study consisted of four distinct study periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LYS006 | Experimental | LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks |
|
| LYS006 + LJN452 | Experimental | LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYS006 | Drug | 5 mg LYS006 capsules orally administered 20 mg b.i.d for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory parameters qualifying and reported as AEs. The number of participants in each category is reported in the table. | From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 113 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score | The markers of fibrosis assessed in this test comprised hyaluronic acid (HA), tissue inhibitor of metalloproteinase (TIMP1) and procollagen III N-terminal peptide (PIIINP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during fibrogenesis as a result of activation of the hepatic stellate cell. The ELF test is a composite score: < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates decreased fibrosis. |
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Inclusion Criteria:
Phenotypic diagnosis of NASH based on the presence of all of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Coronado | California | 92118 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41305844 | Derived | Frias J, Schmouder R, Lawitz E, Zhang Y, Zhou H, Badman MK, Ukomadu C, Weiss HM, Zack J, Yadav B, Martic M, Drakeford C, Koo P, Naoumov NV, Greenbaum LE. Clinical trial: A Phase 2 Randomised Platform Study to Assess Monotherapy and Combination Treatment Regimens in Metabolic Dysfunction-Associated Steatohepatitis. Aliment Pharmacol Ther. 2026 Mar;63(5):637-647. doi: 10.1111/apt.70475. Epub 2025 Nov 26. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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
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Participants underwent a Screening period of up to 33 days followed by a Baseline assessment period of up to 27 days.
Participants were recruited from 10 sites in 3 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | LYS006 | LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks |
| FG001 | LYS006 + LJN452 | LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2021 | Nov 17, 2022 |
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| Tropifexor |
| Drug |
100 ug LJN452 capsules orally administered 200ug once daily for 12 weeks |
|
|
| Baseline and Days 57, 85 and EOS (Day 113) |
| Change From Baseline in Cholesterol: Fasting Lipid Profile Endpoint | Fasting lipid profile (total cholesterol) was examined as a cardiometabolic risk parameter. Total cholesterol was measured on blood samples under fasted conditions and analyzed at a central laboratory. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates cardiovascular risk. | Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113) |
| Change From Baseline in Percent Liver Fat at Day 85 | Percent (%) Liver fat was measured by Magnetic Resonance Imaging Proton Density Liver Fat Fraction (MRIPDFF). Participants underwent magnetic resonance imaging twice during the course of the study (baseline and end of treatment) to quantitate liver fat. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in a component of NAFLD. | Baseline and Day 85 |
| Change From Baseline in Total Body Weight | Body weight (to the nearest 0.1 kilogram [kg] was measured on a calibrated scale. The measurement was performed with the study participant in underwear and without shoes; or while wearing minimal indoor clothing. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in obesity. | Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113) |
| Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Day 85 | HOMA-IR is a test that uses a simultaneous fasting blood glucose test and fasting insulin test to accurately estimate the degree of insulin resistance (IR) and β-cell function (the cells of the pancreas that produce insulin). HOMA-IR scores are classified as follows: Insulin sensitive is considered less than 1.0, Healthy is considered 0.5-1.4, Above 1.8 is early insulin resistance and Above 2.7 is considered significant insulin resistance HOMA-IR= [Fasting glucose (mmol/L) x (fasting insulin (pmol/L)/6)] / 22.5 Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in insulin sensitivity. | Baseline and Day 85 |
| Change From Baseline in Fasting Glucose | Fasting Glucose was examined as a cardiometabolic risk parameter. Total fasting glucose was measured on blood samples under fasted conditions and analyzed at a central laboratory. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in glycemic control. | Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113) |
| Change From Baseline in Fasting Insulin at Day 85 | Fasting insulin was examined as a cardiometabolic risk parameter. Total fasting insulin was measured on blood samples under fasted conditions and analyzed at a central laboratory. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in insulin sensitivity. | Baseline and Day 85 |
| Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c was examined as a cardiometabolic risk parameter. HbA1c was measured on blood samples under fasted conditions and analyzed at a central laboratory. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in glycemic control. | Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113) |
| Change From Baseline in Alanine Aminotransferase (ALT) | Alanine aminotransferase (ALT) is an enzyme found primarily in the liver. ALT is increased with liver damage. In this study, the blood levels of ALT was used to detect liver inflammation. Baseline is defined as the mean of the last 2 non-missing measurements taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in liver inflammation. | Baseline and days 15, 29, 43, 57, 85 and EOS (Day 113) |
| Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) | High-sensitivity C-reactive protein is a blood test marker for inflammation in the body. HsCRP was measured from a blood sample and analyzed at a central laboratory. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in liver inflammation. | Baseline and Days 57, 85 and EOS (Day 113) |
| LYS006 Plasma Concentration | LYS006 plasma concentrations were determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. No methods for imputation of missing data were used. | pre-dose at Days 1, 29, 57 and 85 and post-dose (1, 2, 3 and 4 hours) at Days 29 and 57 |
| Maximum Observed Plasma Concentration (Cmax) of LYS006 | LYS006 plasma concentrations were determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of LYS006 was determined with Phoenix WinNonlin (Version 8.0 or higher). No methods for imputation of missing data were used. | pre-dose and post-dose (1, 2, 3 and 4 hours) at Days 29 and 57 |
| Los Angeles |
| California |
| 90057 |
| United States |
| Novartis Investigative Site | Miami Lakes | Florida | 33014 | United States |
| Novartis Investigative Site | Marietta | Georgia | 30060 | United States |
| Novartis Investigative Site | Honolulu | Hawaii | 96814 | United States |
| Novartis Investigative Site | South Bend | Indiana | 46635 | United States |
| Novartis Investigative Site | Morehead City | North Carolina | 28557 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78215 | United States |
| Novartis Investigative Site | Buenos Aires | C1012AAR | Argentina |
| Novartis Investigative Site | Essen | Nordrhine Westphalia | 45136 | Germany |
| PD Analysis Set | Participants with available PD data and no major protocol deviations with impact on PD data. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LYS006 | LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks |
| BG001 | LYS006 + LJN452 | LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Year |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory parameters qualifying and reported as AEs. The number of participants in each category is reported in the table. | All participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 113 Days |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score | The markers of fibrosis assessed in this test comprised hyaluronic acid (HA), tissue inhibitor of metalloproteinase (TIMP1) and procollagen III N-terminal peptide (PIIINP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during fibrogenesis as a result of activation of the hepatic stellate cell. The ELF test is a composite score: < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates decreased fibrosis. | The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Days 57, 85 and EOS (Day 113) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cholesterol: Fasting Lipid Profile Endpoint | Fasting lipid profile (total cholesterol) was examined as a cardiometabolic risk parameter. Total cholesterol was measured on blood samples under fasted conditions and analyzed at a central laboratory. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates cardiovascular risk. | The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | mmol / L | Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percent Liver Fat at Day 85 | Percent (%) Liver fat was measured by Magnetic Resonance Imaging Proton Density Liver Fat Fraction (MRIPDFF). Participants underwent magnetic resonance imaging twice during the course of the study (baseline and end of treatment) to quantitate liver fat. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in a component of NAFLD. | The overall number of participants analyzed includes all participants in the PD analysis set with evaluable data for the endpoint. | Posted | Mean | Standard Deviation | Percentage of Liver Fat | Baseline and Day 85 |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Body Weight | Body weight (to the nearest 0.1 kilogram [kg] was measured on a calibrated scale. The measurement was performed with the study participant in underwear and without shoes; or while wearing minimal indoor clothing. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in obesity. | The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | kg | Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Day 85 | HOMA-IR is a test that uses a simultaneous fasting blood glucose test and fasting insulin test to accurately estimate the degree of insulin resistance (IR) and β-cell function (the cells of the pancreas that produce insulin). HOMA-IR scores are classified as follows: Insulin sensitive is considered less than 1.0, Healthy is considered 0.5-1.4, Above 1.8 is early insulin resistance and Above 2.7 is considered significant insulin resistance HOMA-IR= [Fasting glucose (mmol/L) x (fasting insulin (pmol/L)/6)] / 22.5 Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in insulin sensitivity. | The overall number of participants analyzed includes all participants in the PD analysis set with evaluable data for the endpoint. | Posted | Mean | Standard Deviation | HOMA-IR score | Baseline and Day 85 |
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| Secondary | Change From Baseline in Fasting Glucose | Fasting Glucose was examined as a cardiometabolic risk parameter. Total fasting glucose was measured on blood samples under fasted conditions and analyzed at a central laboratory. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in glycemic control. | The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | mmol / L | Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113) |
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| Secondary | Change From Baseline in Fasting Insulin at Day 85 | Fasting insulin was examined as a cardiometabolic risk parameter. Total fasting insulin was measured on blood samples under fasted conditions and analyzed at a central laboratory. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in insulin sensitivity. | The overall number of participants analyzed includes all participants in the PD analysis set with evaluable data for the endpoint. | Posted | Mean | Standard Deviation | pmol / L | Baseline and Day 85 |
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| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c was examined as a cardiometabolic risk parameter. HbA1c was measured on blood samples under fasted conditions and analyzed at a central laboratory. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in glycemic control. | The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | Percentage | Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113) |
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| Secondary | Change From Baseline in Alanine Aminotransferase (ALT) | Alanine aminotransferase (ALT) is an enzyme found primarily in the liver. ALT is increased with liver damage. In this study, the blood levels of ALT was used to detect liver inflammation. Baseline is defined as the mean of the last 2 non-missing measurements taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in liver inflammation. | The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | U / L | Baseline and days 15, 29, 43, 57, 85 and EOS (Day 113) |
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| Secondary | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) | High-sensitivity C-reactive protein is a blood test marker for inflammation in the body. HsCRP was measured from a blood sample and analyzed at a central laboratory. Baseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in liver inflammation. | The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | mg / L | Baseline and Days 57, 85 and EOS (Day 113) |
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| Secondary | LYS006 Plasma Concentration | LYS006 plasma concentrations were determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. No methods for imputation of missing data were used. | The overall number of participants analyzed includes all participants. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | ng / mL | pre-dose at Days 1, 29, 57 and 85 and post-dose (1, 2, 3 and 4 hours) at Days 29 and 57 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of LYS006 | LYS006 plasma concentrations were determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of LYS006 was determined with Phoenix WinNonlin (Version 8.0 or higher). No methods for imputation of missing data were used. | The overall number of participants analyzed includes all participants. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Mean | Standard Deviation | ng / mL | pre-dose and post-dose (1, 2, 3 and 4 hours) at Days 29 and 57 |
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Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 113 days.
Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LYS006 | LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks | 0 | 20 | 0 | 20 | 9 | 20 |
| EG001 | LYS006 + LJN452 | LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks | 0 | 21 | 0 | 21 | 15 | 21 |
| EG002 | Total | Total | 0 | 41 | 0 | 41 | 24 | 41 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2022 | Nov 17, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630573 | tropifexor |
Not provided
Not provided
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| SAEs |
|
| AEs leading to discontinuation of study treatment |
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| Units | Counts |
|---|---|
| Participants |
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