Trial · NCT04065841
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
NCT04065841, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2023-12-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis. Trials, record NCT04065841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04065841
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
- NCT number
- NCT04065841
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 234 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Non Alcoholic Steatohepatitis (NASH)
- Interventions
- Tropifexor, Licogliflozin, Placebo
- First posted
- 2019-08-22
- Last updated
- 2025-01-28
- Other registries' IDs
- eudract:2019-002324-32
- Results first posted
- 2023-12-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline | Baseline, Week 48 | Response was defined as at least a one-stage improvement in fibrosis without worsening of nonalcoholic steatohepatitis (NASH) Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. |
| Primary | Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis | 48 weeks | Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. |
| Secondary | Number and Percentage of Participants Who Achieved Resolution of NASH and no Worsening of Fibrosis OR Improvement in Fibrosis by at Least One Stage Without Worsening of NASH | 48 weeks | Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. |
| Secondary | Number and Percentage of Participants With at Least One Stage Improvement in Fibrosis | 48 weeks | Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. |
| Secondary | Number and Percentage of Participants With at Least Two Stage Improvement in Fibrosis Without Worsening of NASH | 48 weeks | Fibrosis staging and Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis. |
| Secondary | Number and Percentage of Participants Achieving 5% or More Reduction in Body Weight at Week 48 Compared With Baseline | Baseline, Week 48 | Whether the participants had 5% or more reduction in body weight. |
| Secondary | Change From Baseline to Week 48 in Percent Liver Fat Content Based on Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI - PDFF) | Baseline, Week 48 | Change in liver fat content based on MRI-PDFF. |
| Secondary | Change From Baseline in Alanine Transaminase (ALT) Over Time | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) | To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH. |
| Secondary | Change From Baseline in Aspartate Aminotransferase (AST) Over Time | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) | To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH. |
| Secondary | Change From Baseline in Gamma-glutamyltransferase (GGT) Over Time | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) | To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline | Baseline, Week 48 | Full Analysis Set (FAS): all participants to whom study treatment has been assigned by randomization and had an assessment of response at Week 48. Efficacy analysis was conducted using the FAS. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis | 48 weeks | Full Analysis Set (FAS): all participants to whom study treatment has been assigned by randomization. Efficacy analysis was conducted using the FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Participants Who Achieved Resolution of NASH and no Worsening of Fibrosis OR Improvement in Fibrosis by at Least One Stage Without Worsening of NASH | 48 weeks | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Participants With at Least One Stage Improvement in Fibrosis | 48 weeks | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Participants With at Least Two Stage Improvement in Fibrosis Without Worsening of NASH | 48 weeks | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Participants Achieving 5% or More Reduction in Body Weight at Week 48 Compared With Baseline | Baseline, Week 48 | Data are reported for the total number of participants in the treatment group with response variable defined. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 48 in Percent Liver Fat Content Based on Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI - PDFF) | Baseline, Week 48 | FAS: all participants to whom study treatment has been assigned by randomization and had an assessment at Week 48. This analysis was performed in 40% of participants. | Percent liver fat | MEAN |
| SECONDARY | Change From Baseline in Alanine Transaminase (ALT) Over Time | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) | The safety analysis set included all participants who received at least one dose of study treatment. At each time point, only participants with a value at both Baseline and that time point were included. | units per liter (U/L) | MEAN |
| SECONDARY | Change From Baseline in Aspartate Aminotransferase (AST) Over Time | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) | The safety analysis set included all participants who received at least one dose of study treatment. At each time point, only participants with a value at both Baseline and that time point were included. | U/L | MEAN |
| SECONDARY | Change From Baseline in Gamma-glutamyltransferase (GGT) Over Time | Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) | The safety analysis set included all participants who received at least one dose of study treatment. At each time point, only participants with a value at both Baseline and that time point were included. | U/L | MEAN |
Source ClinicalTrials.gov
Results by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline | Tropifexor Monotherapy | 6 | Participants | ||
| Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline | Licogliflozin Monotherapy | 9 | Participants | ||
| Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline | Combination Therapy | 10 | Participants | ||
| Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline | Placebo | 4 | Participants | ||
| Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis | Tropifexor Monotherapy | 5 | Participants | ||
| Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis | Licogliflozin Monotherapy | 3 | Participants | ||
| Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis | Combination Therapy | 10 | Participants | ||
| Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis | Placebo | 2 | Participants | ||
| Number and Percentage of Participants Who Achieved Resolution of NASH and no Worsening of Fibrosis OR Improvement in Fibrosis by at Least One Stage Without Worsening of NASH | Tropifexor Monotherapy | 8 | Participants | ||
| Number and Percentage of Participants Who Achieved Resolution of NASH and no Worsening of Fibrosis OR Improvement in Fibrosis by at Least One Stage Without Worsening of NASH | Licogliflozin Monotherapy | 10 | Participants |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tropifexor Monotherapy | 54 | |
| Overall Study | STARTED | Licogliflozin Monotherapy | 55 | |
| Overall Study | STARTED | Combination Therapy | 84 | |
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | COMPLETED | Tropifexor Monotherapy | 25 | |
| Overall Study | COMPLETED | Licogliflozin Monotherapy | 33 | |
| Overall Study | COMPLETED | Combination Therapy | 42 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Tropifexor Monotherapy | 29 | |
| Overall Study | NOT COMPLETED | Licogliflozin Monotherapy | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events200
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 | Abdominal distension | Gastrointestinal disorders | LJN452 | 2 | 53 | |
| other | Abdominal distension | Gastrointestinal disorders | LIK066 | 3 | 55 | |
| other | Abdominal distension | Gastrointestinal disorders | Combination | 5 | 84 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 2 | 41 | |
| other | Abdominal distension | Gastrointestinal disorders | All Patients | 12 | 233 | |
| other | Abdominal pain upper | Gastrointestinal disorders | LJN452 | 4 | 53 | |
| other | Abdominal pain upper | Gastrointestinal disorders | LIK066 | 2 | 55 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Combination | 1 | 84 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 41 | |
| other | Abdominal pain upper | Gastrointestinal disorders | All Patients | 8 | 233 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LJN452 | 0 | 53 |
| Total, all-cause mortality | LIK066 | 0 | 55 |
| Total, all-cause mortality | Combination | 0 | 84 |
| Total, all-cause mortality | Placebo | 0 | 41 |
| Total, all-cause mortality | All Patients | 0 | 233 |
| Total, other adverse events | LJN452 | 35 | 53 |
| Total, other adverse events | LIK066 | 39 | 55 |
| Total, other adverse events | Combination | 54 | 84 |
| Total, other adverse events | Placebo | 23 | 41 |
| Total, other adverse events | All Patients | 151 | 233 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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