Trial · NCT02855164
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE) | 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) | Number of Nonalcoholic steatohepatitis (NASH) patients with TEAEs |
| Primary | Change in Transaminase Levels (ALT) | 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) | 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 |
| Primary | Change in Aspartate Transaminase (AST) | 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) | 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) |
| Primary | Change From Baseline in % of Fat in the Liver Assessed Using Magnetic Resonance Imaging (MRI) | 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) | 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 | Change From Baseline in Weight | 48 weeks | Repeated measures for LS mean change in weight after 12 weeks of treatment |
| Secondary | Change in Body Mass Index (BMI) | 12 weeks | 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 |
| Secondary | Change From Baseline in Waist to Hip (WTH) Ratio | 12 weeks | The LS mean change in waist to hip ratio after 12 weeks of treatment |
| Secondary | Change From Baseline in Biomarker FGF19 | baseline, week 6 | 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 |
| Secondary | Change From Baseline in Biomarker C4 | Week 6, 4 hours post dose | 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 |
| Secondary | Change From Baseline on Markers of Liver Fibrosis, Fibroscan | End of Treatment (EoT): For Parts A&B, EoT was Week 12. For Part C, EoT was Week 48 | 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) |
| Secondary | Change From Baseline on Markers of Liver Fibrosis Panel (ELF) Score | End of Treatment (EoT): For Parts A&B, EoT was Week 12. For Part C, EoT was Week 48 | 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). |
| Secondary | Change From Baseline on Markers of Liver Fibrosis, Fibrotest (Parts A+B) | End of Treatment (EoT):12 weeks | 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) |
| Secondary | Change From Baseline on Markers of Liver Fibrosis, Fibrotest, (Part C) | End of Treatment (EoT) was 48 weeks | 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) |
| Secondary | Change From Baseline on Gamma-glutamyl Transferase (GGT) | EoT for Parts A+B=12 weeks; EoT for Part C = 48 weeks | Summary statistics of change in GGT (IU/L) from baseline by visit up to EoT |
| Secondary | Change From Baseline on Fasting Lipid Profile | End of Treatment (EoT): For Parts A&B, EoT was Week 12. For Part C, EoT was Week 48 | Repeated measures analysis: LS geometric mean ratio of fasting lipids to baseline by visit up to EOT |
| Secondary | Itch Based on a Visual Analog Scale (VAS) Rating Scale | EoT for Parts A+B=12 weeks; EoT for Part C = 48 weeks | 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 |
| Secondary | Pre-dose Trough Concentration (Ctrough) of LJN452 | 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 | Pre-dose Trough Concentration (Ctrough) of tropifexor (LJN452) |
| Secondary | C2h (Steady-state Drug Levels 2 Hours Postdose) of LJN452 | Days 7 and 14 (10 and 30μg LJN452 C2h was not measured day 14) | Summary C2h of tropifexor (LJN452) |
| Secondary | 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 | EoT (Week 48) | Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score) |
| Secondary | Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening - FDA | EoT (Week 48) | Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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