This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis (NCT03517540), a randomized phase 2 study. The primary outcome is Number of Participants With Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03517540 |
| Phase | Phase 2 |
| Condition | Non-alcoholic Steatohepatitis (NASH) |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 193 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Adults with nonalcoholic steatohepatitis (NASH) and liver fibrosis were the intended study population. The registry record identifies NASH as the condition and describes the study population as adult patients with NASH and liver fibrosis. It does not report the detailed eligibility criteria, how fibrosis was established, or the distribution of disease characteristics among enrolled participants.
Intervention
The study assessed tropifexor, also identified as LJN452, and cenicriviroc, or CVC, as individual treatments and in combination. The listed regimens were tropifexor 140 mcg once daily, CVC 150 mg once daily, tropifexor 140 mcg plus CVC 150 mg once daily, and tropifexor 90 mcg plus CVC 150 mg once daily. Each listed regimen was given orally.
Comparator
The randomized parallel-group design allocated participants among the listed regimens. The CVC-only and tropifexor-only arms offer comparisons with combination regimens, while the two combination arms differ in the listed tropifexor dose. The record does not state a placebo arm. It does not report the planned pairwise comparisons or identify which contrast was intended to answer a primary efficacy question.
Primary question
The posted primary outcome is the number of participants with adverse events, including serious adverse events, during the study-treatment period and follow-up described in the record. The broader study purpose was to assess safety, tolerability, and efficacy of tropifexor and CVC, separately and in combination. Secondary outcomes include improvement in fibrosis and resolution of steatohepatitis. The posted information does not establish a single comparative efficacy result for any regimen.
3. Trial Design
This was a randomized, parallel-group phase 2 study. The registry record describes masking as triple and the official title as double-blind. The record does not identify which participants, investigators, or other study personnel were masked, so the precise masking arrangement is not reported in the registry record. The sponsor was Novartis Pharmaceuticals.
Enrollment was 193. The study began on 2018-09-11, and primary completion was recorded as 2020-09-15; its status is completed. The registered population was adults with NASH and liver fibrosis. The registry record does not report detailed entry criteria or baseline characteristics that would show how closely enrolled participants matched that broad description.
Arm A received tropifexor 140 mcg once daily by mouth. Arm B received CVC 150 mg once daily by mouth. Arm C received tropifexor 140 mcg plus CVC 150 mg once daily by mouth. Arm D received tropifexor 90 mg plus CVC 150 mg once daily by mouth. These are the treatment regimens named in the arm descriptions; the registry record does not report adherence, dose interruptions, or treatment exposure by arm in the information summarized for the posted outcomes.
The primary outcome was the number of participants with adverse events, with collection from the first dose through the end of study treatment at week 48 and then up to a maximum duration of 66 weeks. The listed secondary outcomes concern at least a one point improvement in fibrosis and resolution of steatohepatitis. The record identifies 3 outcome measures and 8 analyses, but the primary outcome is not reduced to one comparison. Detailed allocation procedures, the sample-size justification, interim analyses, and the statistical plan are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 450 of 643 subjects discontinued during screening phase
Overall Study
| Stage | Arm A: Tropifexor (LJN452) - Dose 1 | Arm B: Cenicriviroc (CVC) | Arm C: Tropifexor (LJN452) Dose 1 + CVC | Arm D: Tropifexor Dose 2 + CVC |
|---|---|---|---|---|
| STARTED | 50 | 48 | 47 | 48 |
| COMPLETED | 36 | 41 | 38 | 43 |
| NOT COMPLETED | 14 | 7 | 9 | 5 |
Reasons for not completing this period:
| Reason | Arm A: Tropifexor (LJN452) - Dose 1 | Arm B: Cenicriviroc (CVC) | Arm C: Tropifexor (LJN452) Dose 1 + CVC | Arm D: Tropifexor Dose 2 + CVC |
|---|---|---|---|---|
| Protocol Violation | 2 | 0 | 0 | 1 |
| Adverse Event | 9 | 3 | 8 | 1 |
| Withdrawal by Subject | 3 | 4 | 1 | 3 |
Analysis population for the primary outcome, as defined in the registry: Safety set (SAF) - All patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Of note, the statement that a patient had no AEs also constituted a safety assessment. Patients were analyzed according to the treatment received
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Full analysis set (FAS) - All participants to whom study treatment was assigned (excluding patients who were mis-randomized and did not take investigational drug. Mis-randomized participants were those who were not qualified for randomization but were inadvertently randomized into the study). Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at randomization.
| Characteristic | Unit | Arm A: Tropifexor (LJN452) - Dose 1 | Arm B: Cenicriviroc (CVC) | Arm C: Tropifexor (LJN452) Dose 1 + CVC | Arm D: Tropifexor Dose 2 + CVC | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 50 | 48 | 47 | 48 | 193 | |
| Age, Continuous | years | 54.8 (SD 13.35) | 53.7 (SD 11.79) | 54.7 (SD 12.65) | 54.9 (SD 12.29) | 54.5 (SD 12.52) |
| Age, Customized: <65 | Participants | 35 | 39 | 37 | 38 | 149 |
| Age, Customized: >=65 | Participants | 15 | 9 | 10 | 10 | 44 |
| Sex/Gender, Customized: Male | Participants | 20 | 17 | 18 | 25 | 80 |
| Sex/Gender, Customized: Female | Participants | 30 | 31 | 29 | 23 | 113 |
| Race/Ethnicity, Customized: White | Participants | 41 | 44 | 40 | 43 | 168 |
| Race/Ethnicity, Customized: Asian | Participants | 7 | 4 | 5 | 5 | 21 |
| Race/Ethnicity, Customized: Black | Participants | 1 | 0 | 2 | 0 | 3 |
| Race/Ethnicity, Customized: Unknown | Participants | 1 | 0 | 0 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events, measured over AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with adverse events. The registry description includes adverse events and serious adverse events, defining adverse events as untoward signs or symptoms occurring during study treatment and then up to 66 weeks. Collection began with the first dose and continued until the end of study treatment at week 48, followed by collection up to the maximum duration stated in the record. The safety population includes patients who received at least one dose and had at least one post-baseline safety assessment; a statement that a patient had no adverse events also counted as a safety assessment. Participants were analyzed according to treatment received.
In general, adverse-event outcomes are used to describe the safety experience observed during a study. Counts can show how many participants were recorded as experiencing an event, while serious and other adverse events provide distinct ways to describe the event data. These summaries do not, on their own, establish that treatment caused an event or explain its clinical context. A comparison between arms also requires a clearly defined contrast and analysis; the registry record does not present one single primary-outcome comparison for the several categories or time points. The listed secondary endpoints address fibrosis improvement and steatohepatitis resolution, but their results are not reported in the information summarized in the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is a safety count, not a direct measure of change in NASH or liver fibrosis. The record lists serious adverse events and other adverse events for each treatment arm, with the number at risk and the number affected. For serious adverse events, the listed counts are 5 among 50 for tropifexor 140mg, 3 among 48 for CVC 150mg, 4 among 47 for tropifexor 140mcg plus CVC 150mg, and 10 among 48 for tropifexor 90 mg plus CVC 150 mg. For other adverse events, the counts are 39 among 50, 30 among 48, 33 among 47, and 32 among 48, respectively. Deaths are recorded as 0 in each arm.
These are descriptive arm-level counts. They do not establish whether differences between arms are statistically reliable or attributable to treatment. The registry record does not report confidence intervals, p-values, adjusted estimates, or a single prespecified contrast for this primary outcome. A reader should therefore avoid treating the counts as a ranked comparison of the regimens or as evidence that one regimen has a different safety profile from another. Differences in the number at risk also matter when interpreting raw counts; the counts alone do not express uncertainty around any comparison.
The record also lists serious adverse-event terms and percentages: COVID-19, 4.2%; acute lymphocytic leukaemia, 2.1%; cerebrovascular accident, 2.1%; depression suicidal, 2.1%; benign prostatic hyperplasia, 2.1%; and coronary artery disease, 2.1%. These entries describe terms listed in the registry record. The information summarized does not identify the arm for each term, provide further clinical details, or establish whether an event was caused by a study drug.
The study's broader purpose included efficacy, and its secondary outcomes concern fibrosis improvement and resolution of steatohepatitis. Their numerical results and comparative estimates are not reported in the registry record. Consequently, the posted safety counts cannot answer whether any regimen changed either disease outcome. The enrollment figure and completed status describe the study record, but neither substitutes for outcome estimates or information about precision. A cautious reading distinguishes the observed counts from an inferential treatment comparison, and distinguishes a safety description from a conclusion about efficacy.
9. Statistical Methods Explained
What kind of outcome is the primary endpoint?
The primary endpoint is a count of participants recorded as having adverse events. The registry record separately lists serious adverse events and other adverse events, alongside the number at risk in each arm. In general, this kind of outcome is binary at the participant level for a specified event definition: a participant is classified as having or not having the event under consideration. Summing those classifications produces a count. That count is not the same as a measure of event severity, duration, number of repeated events, or time until the first event unless those details are separately defined and reported. The registry record does not provide those additional summaries.
Why do the denominators matter?
The reported number at risk indicates the participants represented in each arm's safety summary. Raw counts are easiest to interpret alongside those denominators, because counts may reflect different numbers of participants at risk. In general, an arm-level count describes what was observed among the listed participants; it does not by itself quantify uncertainty or make an adjusted comparison. A confidence interval, when reported, expresses a range of values compatible with the data and the method used under specified assumptions. No confidence interval for a primary-outcome comparison is reported in the registry record.
What does randomization contribute?
In general, random allocation is intended to make treatment groups comparable at the point of assignment, including with respect to measured and unmeasured characteristics on average. Randomization does not guarantee that the groups have identical characteristics, and it does not remove the need to report the analysis population, outcome definitions, missing-data handling, and uncertainty. This study is recorded as randomized and parallel-group, but the allocation procedure and statistical methods for comparing arms are not reported in the registry record. The posted safety population was analyzed according to treatment received, which is distinct from an analysis based strictly on assigned treatment.
How should masking be understood?
The registry field describes masking as triple, while the official title uses the wording double-blind. These descriptions are both present in the record. The particular people masked and how masking was maintained are not reported in the registry record. In general, masking can reduce the influence of expectations on treatment delivery, reporting, or assessment, depending on who is masked and how outcomes are measured. The label alone does not reveal whether these effects occurred in this study.
What can be inferred from counts without a comparative analysis?
Counts allow a descriptive account of the number of participants recorded with events. A treatment comparison requires a defined estimand or contrast, a statistical method, and a way to express uncertainty. For binary outcomes, general approaches may compare proportions or model the probability of an event, but no particular method should be attributed to this trial without documentation. The registry record explicitly does not reduce the primary outcome, which has several categories or time points, to one comparison. It does not report a test statistic, p-value, confidence interval, or adjusted treatment effect for the primary endpoint.
In general, a p-value measures how unusual data at least as incompatible with a specified null hypothesis would be under the assumptions of a statistical model. It is not the probability that a treatment has no effect, and it does not measure the size or clinical importance of an effect. Since no primary-outcome p-value is reported in the registry record, there is no basis to describe a statistically significant or nonsignificant result for a defined primary comparison.
Why can event counts require careful interpretation?
Adverse events may differ in seriousness, type, timing, and recurrence. A single participant may experience more than one event, and a participant-level count does not reveal the total number of event episodes unless that is separately reported. The registry record provides participant counts for serious and other adverse events and lists selected serious-event terms, but the information summarized does not provide event-level detail, timing by arm, or causal assessments. In general, event counts are descriptive safety evidence and should not be read as proof of causation.
What is not established by the posted methods information?
The registry record does not report a sample-size justification, a prespecified statistical analysis plan, interim analyses, multiplicity procedures, or detailed missing-data methods. It also does not report confidence intervals or adjusted estimates for the primary outcome. The study's recorded enrollment and outcome counts should not be used to infer the design's intended power or the precision of a treatment comparison. Without the missing analysis details, the appropriate interpretation remains descriptive: the record reports event counts by treatment received, but does not supply a single inferential comparison for the primary endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The record identifies 3 outcome measures and 8 analyses, and lists secondary outcomes for fibrosis improvement and resolution of steatohepatitis. It also notes that the primary outcome has several categories or time points and is not reduced to one comparison. The registry record does not report which comparisons were prespecified as primary, how the analyses relate to one another, or whether any adjustment for multiple testing was planned or applied. Without those details, the chance of false-positive findings across multiple comparisons cannot be evaluated from the posted information.
Missing-data handling is not reported in the registry record. The safety population is defined as patients who received at least one dose and had at least one post-baseline safety assessment. A statement that a patient had no adverse events counted as a safety assessment, and patients were analyzed according to treatment received. This definition clarifies who could enter the safety summaries, but it does not describe what happened when a participant had incomplete follow-up, discontinued treatment, or had missing outcome information. The record does not specify imputation methods, censoring rules, or sensitivity analyses for missing data.
The registry record also does not report the sample-size justification, interim analyses, or detailed statistical plan. Those omissions limit assessment of whether the analysis matched the intended design and how uncertainty or multiple outcomes were handled. The posted counts can be read descriptively within the stated safety population, but they do not resolve these methodological questions or support an unreported efficacy comparison.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Tropifexor 140mg | 5 | 50 | 10.0% |
| CVC 150mg | 3 | 48 | 6.2% |
| Tropifexor 140mcg + CVC 150mg | 4 | 47 | 8.5% |
| Tropifexor 90 mg + CVC 150 mg | 10 | 48 | 20.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Tropifexor 140mg | 0 of 50 |
| CVC 150mg | 0 of 48 |
| Tropifexor 140mcg + CVC 150mg | 0 of 47 |
| Tropifexor 90 mg + CVC 150 mg | 0 of 48 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Tropifexor 140mg | 39 of 50 |
| CVC 150mg | 30 of 48 |
| Tropifexor 140mcg + CVC 150mg | 33 of 47 |
| Tropifexor 90 mg + CVC 150 mg | 32 of 48 |
Most frequent serious adverse event terms
| Event term | Organ system | Tropifexor 140mg | CVC 150mg | Tropifexor 140mcg + CVC 150mg | Tropifexor 90 mg + CVC 150 mg |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | 0 of 50 | 0 of 48 | 0 of 47 | 2 of 48 |
| Cerebrovascular accident | Nervous system disorders | 0 of 50 | 0 of 48 | 1 of 47 | 1 of 48 |
| Coronary artery disease | Cardiac disorders | 0 of 50 | 1 of 48 | 0 of 47 | 0 of 48 |
| Myocardial infarction | Cardiac disorders | 0 of 50 | 0 of 48 | 0 of 47 | 1 of 48 |
| Duodenal ulcer | Gastrointestinal disorders | 1 of 50 | 0 of 48 | 0 of 47 | 0 of 48 |
| Gastritis | Gastrointestinal disorders | 1 of 50 | 0 of 48 | 0 of 47 | 0 of 48 |
| Oesophageal ulcer | Gastrointestinal disorders | 1 of 50 | 0 of 48 | 0 of 47 | 0 of 48 |
| Pancreatitis acute | Gastrointestinal disorders | 0 of 50 | 1 of 48 | 0 of 47 | 0 of 48 |
| Non-cardiac chest pain | General disorders | 1 of 50 | 0 of 48 | 0 of 47 | 0 of 48 |
| Biliary dyskinesia | Hepatobiliary disorders | 0 of 50 | 0 of 48 | 0 of 47 | 1 of 48 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Tropifexor 140mg | CVC 150mg | Tropifexor 140mcg + CVC 150mg | Tropifexor 90 mg + CVC 150 mg |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | 20 of 50 | 10 of 48 | 15 of 47 | 10 of 48 |
| Nausea | Gastrointestinal disorders | 2 of 50 | 6 of 48 | 7 of 47 | 6 of 48 |
| Fatigue | General disorders | 7 of 50 | 4 of 48 | 5 of 47 | 4 of 48 |
| Constipation | Gastrointestinal disorders | 5 of 50 | 2 of 48 | 6 of 47 | 3 of 48 |
| Urinary tract infection | Infections and infestations | 7 of 50 | 3 of 48 | 2 of 47 | 4 of 48 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 6 of 50 | 3 of 48 | 6 of 47 | 1 of 48 |
| Abdominal pain | Gastrointestinal disorders | 5 of 50 | 3 of 48 | 5 of 47 | 2 of 48 |
| Upper respiratory tract infection | Infections and infestations | 3 of 50 | 2 of 48 | 5 of 47 | 5 of 48 |
| Asthenia | General disorders | 4 of 50 | 2 of 48 | 5 of 47 | 3 of 48 |
| Diarrhoea | Gastrointestinal disorders | 2 of 50 | 7 of 48 | 4 of 47 | 0 of 48 |
Serious events with the highest arm-level rate: covid-19 (4.2%), acute lymphocytic leukaemia (2.1%), cerebrovascular accident (2.1%), depression suicidal (2.1%), benign prostatic hyperplasia (2.1%).
The safety summaries distinguish serious adverse events from other adverse events and give the number at risk and affected in each arm. For serious adverse events, the registry lists 5 affected among 50 at risk with tropifexor 140mg; 3 among 48 with CVC 150mg; 4 among 47 with tropifexor 140mcg plus CVC 150mg; and 10 among 48 with tropifexor 90 mg plus CVC 150 mg. The other-adverse-event counts are 39 among 50, 30 among 48, 33 among 47, and 32 among 48, respectively. The registry records 0 deaths for each arm.
These are participant counts, not a comparative estimate with an uncertainty interval. In general, a serious adverse event is a category defined by seriousness criteria; a count does not indicate that all events had the same clinical nature or outcome. The registry lists COVID-19 at 4.2%, and acute lymphocytic leukaemia, cerebrovascular accident, depression suicidal, benign prostatic hyperplasia, and coronary artery disease at 2.1% each among the top serious terms. Arm attribution and further clinical context for those terms are not reported in the registry record. The listed event counts do not establish causation or a statistically reliable difference between treatments.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized phase 2 study of tropifexor and CVC in adults with NASH and liver fibrosis. Its posted primary endpoint is a safety outcome: the number of participants with adverse events. The record gives serious and other adverse-event counts by treatment received and records no deaths in the listed groups. These registry entries describe the safety experience captured in the registry summaries during the stated observation period.
They do not establish that a study drug caused an event, that a regimen is safer than another, or that any observed difference between arms is statistically reliable. The registry record does not provide a single primary-outcome comparison, confidence intervals, p-values, or adjusted estimates. The posted event terms also do not supply enough detail to assess individual cases or attribute each term to a particular treatment arm.
The study's stated purpose also included efficacy, and the listed secondary outcomes concern improvement in fibrosis and resolution of steatohepatitis. Their results are not reported in the registry information, so no conclusion about those outcomes follows from the safety counts. The completed status and enrollment of 193 describe trial conduct, not the size, precision, or clinical importance of a treatment effect.
In general, trial results need to be interpreted in light of the outcome definitions, populations analyzed, missing data, analysis methods, and uncertainty. Several of those details are not reported in the registry record. The soundest reading is therefore limited: the record reports arm-level safety counts for the defined safety population, but does not supply a comprehensive statistical comparison or efficacy result.
13. Why This Trial Matters Statistically
This trial is statistically notable because it places single-agent and combination regimens in a randomized parallel-group study, while the posted primary endpoint is a count-based safety outcome. That structure makes it important to distinguish descriptions within each arm from inferential comparisons between arms. Seeing counts side by side is not equivalent to having a prespecified contrast, an estimate of the difference, or an uncertainty interval.
The safety population is defined according to treatment received and requires at least one dose and a post-baseline safety assessment. This is useful context for understanding who contributes to the posted safety counts, but it is not interchangeable with every possible randomized analysis population. The record does not report the allocation procedure or detailed missing-data handling, so readers cannot assess those aspects of the statistical analysis from the registry information.
The record also lists secondary outcomes addressing fibrosis improvement and steatohepatitis resolution, yet the results for those outcomes are not reported in the information summarized. This illustrates why a trial's stated purpose and outcome list should be kept separate from the results actually available in a registry record. A broad study aim does not establish a treatment effect on a disease outcome.
Finally, the primary outcome is recorded across several categories or time points without one consolidated comparison. Without details about multiplicity, the analysis plan, or uncertainty estimates, the posted counts support a descriptive reading rather than a definitive ranking of regimens. Recognizing that distinction is central to statistical interpretation in clinical research.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific limitations follow from what the registry record does not report. Detailed eligibility criteria and baseline characteristics are not included in the information summarized, which limits assessment of the enrolled population beyond the broad description of adults with NASH and liver fibrosis. The record does not describe allocation procedures, the people masked, or how masking was maintained. The official title and masking description use different wording, and the record does not clarify the practical masking arrangement.
The primary outcome has several categories or time points and is not presented as one comparison. No confidence intervals, p-values, adjusted estimates, or detailed statistical methods for this endpoint are reported. The record also does not provide the sample-size justification, interim analyses, or multiplicity procedures. Missing-data methods and sensitivity analyses are not reported, leaving uncertainty about how incomplete follow-up was handled.
For safety, the arm-level counts do not provide event-level timing, recurrence, further clinical context, or causal assessment. The listed serious-event terms are not linked to arms in the information summarized. The secondary outcomes are named, but their numerical results are not reported. These gaps restrict interpretation to the posted safety counts and prevent assessment of efficacy or a comprehensive comparative treatment effect. The information summarized should not be treated as a substitute for a complete results report.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis — NCT03517540.
- Registry record last updated 2022-04-29; status last verified 2022-04.
- Results first posted 2021-11-12.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes NCT03517540, a completed randomized phase 2 parallel-group study sponsored by Novartis Pharmaceuticals. Enrollment was 193, and the recorded study dates are 2018-09-11 for start and 2020-09-15 for primary completion. The study enrolled adults with NASH and liver fibrosis and assessed tropifexor, CVC, and combination regimens.
The primary outcome was the number of participants with adverse events, collected from the first dose through treatment ending at week 48 and then up to a maximum duration of 66 weeks. The record lists serious and other adverse-event counts by treatment received and 0 deaths in each arm. Secondary outcomes concern fibrosis improvement and resolution of steatohepatitis, but their results are not reported in the information summarized. The registry record does not provide a single primary-outcome comparison, detailed statistical methods, confidence intervals, or p-values.