Trial · NCT02855164
Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)
NCT02855164, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2021-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH). Trials, record NCT02855164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02855164
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)
- NCT number
- NCT02855164
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 350 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Interventions
- Tropifexor (LJN452), Placebo
- First posted
- 2016-08-04
- Last updated
- 2021-09-05
- Other registries' IDs
- eudract:2015-005215-33
- Results first posted
- 2021-07-29
- Limitations and caveats
- No outputs were planned; and are not available for determining the effects of tropifexor on primary endpoints in the subset of patients who had historical biopsy data.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Safety analysis set (SAS) is all subjects who received at least one dose of drug and had at least one post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Full analysis set (FAS): All subjects to whom study treatment had been assigned.~Following the intent-to-treat (ITT) principle, subjects were analyzed according to the treatment they have been assigned to at randomization. | IU/L | MEAN |
| 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) | Full Analysis Set (FAS) | U/L | MEAN |
| 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) | FAS | percentage of fat in the liver | MEAN |
| SECONDARY | Change From Baseline in Weight | 48 weeks | FAS | kg | MEAN |
| SECONDARY | Change in Body Mass Index (BMI) | 12 weeks | FAS | kg/m2 | MEAN |
| SECONDARY | Change From Baseline in Waist to Hip (WTH) Ratio | 12 weeks | FAS | ratio | MEAN |
| SECONDARY | Change From Baseline in Biomarker FGF19 | baseline, week 6 | FAS | pg/mL | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Biomarker C4 | Week 6, 4 hours post dose | FAS | ng/mL | MEAN |
| 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 | FAS | scores | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group223
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE) | LJN452 10 μg | 5 | Participants | ||
| Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE) | LJN452 30 μg | 11 | Participants | ||
| Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE) | LJN452 60 μg | 24 | Participants | ||
| Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE) | LJN452 90 μg | 61 | Participants | ||
| Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE) | Placebo A+B | 31 | Participants | ||
| Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE) | LJN452 140 μg | 49 | Participants | ||
| Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE) | LNJ452 200 μg | 49 | Participants | ||
| Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE) | Placebo Part C | 46 | Participants | ||
| Change in Transaminase Levels (ALT) | LJN452 10 μg | -16.7 | Standard Deviation 17.53 | IU/L | |
| Change in Transaminase Levels (ALT) | LJN452 30 μg | -12.0 | Standard Deviation 35.99 | IU/L |
1 to 10 of 223Source ClinicalTrials.gov
See all 223 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Parts A + B (Randomized Set) | STARTED | LJN452 10 μg | 14 | |
| Parts A + B (Randomized Set) | STARTED | LJN452 30 μg | 16 | |
| Parts A + B (Randomized Set) | STARTED | LJN452 60 μg | 37 | |
| Parts A + B (Randomized Set) | STARTED | LJN452 90 μg | 85 | |
| Parts A + B (Randomized Set) | STARTED | Placebo A+B | 46 | |
| Parts A + B (Randomized Set) | STARTED | LJN452 140 μg | 0 | |
| Parts A + B (Randomized Set) | STARTED | LJN452 200 μg | 0 | |
| Parts A + B (Randomized Set) | STARTED | Placebo C | 0 | |
| Parts A + B (Randomized Set) | COMPLETED | LJN452 10 μg | 14 | |
| Parts A + B (Randomized Set) | COMPLETED | LJN452 30 μg | 16 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events576
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | LJN452 10 μg | 0 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | LJN452 30 μg | 1 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | LJN452 60 μg | 0 | 37 | |
| other | Anaemia | Blood and lymphatic system disorders | LJN452 90 μg | 0 | 85 | |
| other | Anaemia | Blood and lymphatic system disorders | LJN452 140 μg | 1 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | LJN452 200 μg | 0 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 97 | |
| other | Anaemia | Blood and lymphatic system disorders | Total | 3 | 350 | |
| other | Abdominal distension | Gastrointestinal disorders | LJN452 10 μg | 0 | 13 | |
| other | Abdominal distension | Gastrointestinal disorders | LJN452 30 μg | 0 | 17 |
1 to 10 of 576Source ClinicalTrials.gov
See all 576 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LJN452 10 μg | 0 | 13 |
| Total, all-cause mortality | LJN452 30 μg | 0 | 17 |
| Total, all-cause mortality | LJN452 60 μg | 0 | 37 |
| Total, all-cause mortality | LJN452 90 μg | 0 | 85 |
| Total, all-cause mortality | LJN452 140 μg | 0 | 50 |
| Total, all-cause mortality | LJN452 200 μg | 0 | 51 |
| Total, all-cause mortality | Placebo | 0 | 97 |
| Total, all-cause mortality | Total | 0 | 350 |
| Total, other adverse events | LJN452 10 μg | 5 | 13 |
| Total, other adverse events | LJN452 30 μg | 11 | 17 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02855164
GET https://conductscience.org/api/trials/v1/NCT02855164/registered?page=2