Trial · NCT03517540
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
NCT03517540, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-11-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis. Trials, record NCT03517540. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03517540
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
- NCT number
- NCT03517540
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 193 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Interventions
- Tropifexor (LJN452), Cenicriviroc (CVC)
- First posted
- 2018-05-07
- Last updated
- 2022-04-29
- Other registries' IDs
- eudract:2017-004208-24
- Results first posted
- 2021-11-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 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 | Occurrence of adverse events and serious adverse events Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and then up to 66 weeks |
| Secondary | Proportion of Participants Who Have at Least a One Point Improvement in Fibrosis | baseline to 48 Weeks | Efficacy of tropifexor + CVC in patients with Nonalcoholic steatohepatitis (NASH) with fibrosis stage F2/F3 as assessed by histological improvement after 48 weeks of treatment compared to monotherapies (tropifexor and CVC) compared to baseline biopsy |
| Secondary | Proportion of Participants With Resolution of Steatohepatitis | baseline to 48 weeks | Efficacy of tropifexor + CVC in patients with Nonalcoholic steatohepatitis (NASH) with fibrosis stage F2/F3 as assessed by histological improvement after 48 weeks of treatment compared to monotherapies (tropifexor and CVC) compared to baseline biopsy |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | 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 | 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 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants Who Have at Least a One Point Improvement in Fibrosis | baseline to 48 Weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Resolution of Steatohepatitis | baseline to 48 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Arm A: Tropifexor (LJN452) - Dose 1 | Number of participants with at least one Adverse Event (AE) | 42 | Participants | |
| Number of Participants With Adverse Events | Arm B: Cenicriviroc (CVC) | Number of participants with at least one Adverse Event (AE) | 41 | Participants | |
| Number of Participants With Adverse Events | Arm C: Tropifexor (LJN452) Dose 1 + CVC | Number of participants with at least one Adverse Event (AE) | 40 | Participants | |
| Number of Participants With Adverse Events | Arm D: Tropifexor Dose 2 + CVC | Number of participants with at least one Adverse Event (AE) | 42 | Participants | |
| Number of Participants With Adverse Events | Arm A: Tropifexor (LJN452) - Dose 1 | Number of participants with at least one Serious Adverse Events (SAEs) | 5 | Participants | |
| Number of Participants With Adverse Events | Arm B: Cenicriviroc (CVC) | Number of participants with at least one Serious Adverse Events (SAEs) | 3 | Participants | |
| Number of Participants With Adverse Events | Arm C: Tropifexor (LJN452) Dose 1 + CVC | Number of participants with at least one Serious Adverse Events (SAEs) | 4 | Participants | |
| Number of Participants With Adverse Events | Arm D: Tropifexor Dose 2 + CVC | Number of participants with at least one Serious Adverse Events (SAEs) | 10 | Participants | |
| Number of Participants With Adverse Events | Arm A: Tropifexor (LJN452) - Dose 1 | Deaths | 0 | Participants | |
| Number of Participants With Adverse Events | Arm B: Cenicriviroc (CVC) | Deaths | 0 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Tropifexor (LJN452) - Dose 1 | 50 | |
| Overall Study | STARTED | Arm B: Cenicriviroc (CVC) | 48 | |
| Overall Study | STARTED | Arm C: Tropifexor (LJN452) Dose 1 + CVC | 47 | |
| Overall Study | STARTED | Arm D: Tropifexor Dose 2 + CVC | 48 | |
| Overall Study | COMPLETED | Arm A: Tropifexor (LJN452) - Dose 1 | 36 | |
| Overall Study | COMPLETED | Arm B: Cenicriviroc (CVC) | 41 | |
| Overall Study | COMPLETED | Arm C: Tropifexor (LJN452) Dose 1 + CVC | 38 | |
| Overall Study | COMPLETED | Arm D: Tropifexor Dose 2 + CVC | 43 | |
| Overall Study | NOT COMPLETED | Arm A: Tropifexor (LJN452) - Dose 1 | 14 | |
| Overall Study | NOT COMPLETED | Arm B: Cenicriviroc (CVC) | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events224
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 | Cataract | Eye disorders | Tropifexor 140mg | 0 | 50 | |
| other | Cataract | Eye disorders | CVC 150mg | 3 | 48 | |
| other | Cataract | Eye disorders | Tropifexor 140mcg + CVC 150mg | 0 | 47 | |
| other | Cataract | Eye disorders | Tropifexor 90 mg + CVC 150 mg | 0 | 48 | |
| other | Abdominal distension | Gastrointestinal disorders | Tropifexor 140mg | 2 | 50 | |
| other | Abdominal distension | Gastrointestinal disorders | CVC 150mg | 3 | 48 | |
| other | Abdominal distension | Gastrointestinal disorders | Tropifexor 140mcg + CVC 150mg | 1 | 47 | |
| other | Abdominal distension | Gastrointestinal disorders | Tropifexor 90 mg + CVC 150 mg | 4 | 48 | |
| other | Abdominal pain | Gastrointestinal disorders | Tropifexor 140mg | 5 | 50 | |
| other | Abdominal pain | Gastrointestinal disorders | CVC 150mg | 3 | 48 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tropifexor 140mg | 0 | 50 |
| Total, all-cause mortality | CVC 150mg | 0 | 48 |
| Total, all-cause mortality | Tropifexor 140mcg + CVC 150mg | 0 | 47 |
| Total, all-cause mortality | Tropifexor 90 mg + CVC 150 mg | 0 | 48 |
| Total, other adverse events | Tropifexor 140mg | 39 | 50 |
| Total, other adverse events | CVC 150mg | 30 | 48 |
| Total, other adverse events | Tropifexor 140mcg + CVC 150mg | 33 | 47 |
| Total, other adverse events | Tropifexor 90 mg + CVC 150 mg | 32 | 48 |
| Total, serious adverse events | Tropifexor 140mg | 5 | 50 |
| Total, serious adverse events | CVC 150mg | 3 | 48 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT03517540
GET https://conductscience.org/api/trials/v1/NCT03517540/events?page=2