Trial · NCT01811472
Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients
NCT01811472, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2016-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients. Trials, record NCT01811472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01811472
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients
- NCT number
- NCT01811472
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Non-alcoholic Fatty Liver Disease (NAFLD)
- Interventions
- LCQ908, placebo
- First posted
- 2013-03-14
- Last updated
- 2016-02-04
- Other registries' IDs
- eudract:2013-000049-38
- Results first posted
- 2016-02-04
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24 | From baseline to week 24 | Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14). |
| Secondary | Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12 | From baseline to week 12 | Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14). |
| Secondary | Percentage of Responders at Week 12 | At week 12 | The response criteria are defined as: a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content \< 10% d. Liver fat content \< 5.6%. Percentage is calculated as (m/n)\*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit. |
| Secondary | Percentage of Responders at Week 24 | From baseline to week 24 | The response criteria are defined as: a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content \< 10% d. Liver fat content \< 5.6%. Percentage is calculated as (m/n)\*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit. |
| Secondary | Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6 | From Baseline to week 6 | Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization). Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate. |
| Secondary | Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12 | From Baseline to week 12 | Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization). Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate. |
| Secondary | Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24 | From Baseline to week 24 | Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization). Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate. |
| Secondary | Percentage of Patients With Normalized Liver Enzymes | Baseline, week 6, week 12 and week 24 | Normalized liver enzymes defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 40 U/L. Normal/High categories at baseline are defined by criteria of normal. Better is defined as high' at baseline and 'normal' post-dose; Same is defined as 'normal' at baseline and 'normal' post-dose or 'high' at baseline and 'high' post-dose; Worse is defined as 'normal' at baseline and 'high' post-dose. |
| Secondary | Percent Change From Baseline in Fasting Triglycerides | Baseline, 6, 12 and 24 weeks | Blood samples were collected for a fasting triglycerides (TG) after a 10-hour (overnight) fast. Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline. Baseline is defined as the value collected at Week 0 (randomization). |
| Secondary | Post-prandial Peak Triglycerides Over 0 - 8 Hours | Baseline, 6 and 24 weeks | Post-prandial peak triglycerides is reported as maximum triglyceride value over 0-8 hours. Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model. Baseline is defined as the value collected at Week 0 (randomization). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24 | From baseline to week 24 | Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 24 are included in this analysis. | Percentage of liver fat | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12 | From baseline to week 12 | Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 12 are included in this analysis. | Percentage of liver fat | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Responders at Week 12 | At week 12 | Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 12 were included in this endpoint analysis. | Percentage of responders | NUMBER |
| SECONDARY | Percentage of Responders at Week 24 | From baseline to week 24 | Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 24 were included in this endpoint analysis. | Percentage of responders | NUMBER |
| SECONDARY | Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6 | From Baseline to week 6 | Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoint were included in this endpoint analysis. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12 | From Baseline to week 12 | Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 12 were included in this endpoint analysis. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24 | From Baseline to week 24 | Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 24 were included in this endpoint analysis. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients With Normalized Liver Enzymes | Baseline, week 6, week 12 and week 24 | Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoints were included in this endpoint analysis. | Percentage of patients | NUMBER |
| SECONDARY | Percent Change From Baseline in Fasting Triglycerides | Baseline, 6, 12 and 24 weeks | Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis | percent change | GEOMETRIC_MEAN |
| SECONDARY | Post-prandial Peak Triglycerides Over 0 - 8 Hours | Baseline, 6 and 24 weeks | Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis | mg/dL | GEOMETRIC_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group123
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24 | Placebo | 0.00 | 95% Confidence Interval -1.63 to 1.63 | Percentage of liver fat | |
| Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24 | Pradigastat (LCQ908) 5mg/10mg | -1.68 | 95% Confidence Interval -3.93 to 0.56 | Percentage of liver fat | |
| Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24 | Pradigastat (LCQ908) 10mg/20mg | -2.89 | 95% Confidence Interval -4.59 to -1.18 | Percentage of liver fat | |
| Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12 | Placebo | -0.80 | 90% Confidence Interval -2.31 to 0.72 | Percentage of liver fat | |
| Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12 | Pradigastat (LCQ908) 5mg/10mg | -1.71 | 90% Confidence Interval -3.79 to 0.37 | Percentage of liver fat | |
| Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12 | Pradigastat (LCQ908) 10mg/20mg | -2.98 | 90% Confidence Interval -4.55 to -1.42 | Percentage of liver fat | |
| Percentage of Responders at Week 12 | Placebo | At least 30% reduction in percent liver fat | 10.00 | Percentage of responders | |
| Percentage of Responders at Week 12 | Pradigastat (LCQ908) 5mg/10mg | At least 30% reduction in percent liver fat | 18.18 | Percentage of responders | |
| Percentage of Responders at Week 12 | Pradigastat (LCQ908) 10mg/20mg | At least 30% reduction in percent liver fat | 31.58 | Percentage of responders | |
| Percentage of Responders at Week 12 | Placebo | At least 50% reduction in percent liver fat | 5.00 | Percentage of responders |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | STARTED | Pradigastat (LCQ908) 5mg/10mg | 11 | |
| Overall Study | STARTED | Pradigastat (LCQ908) 10mg/20mg | 21 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | COMPLETED | Pradigastat (LCQ908) 5mg/10mg | 11 | |
| Overall Study | COMPLETED | Pradigastat (LCQ908) 10mg/20mg | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Pradigastat (LCQ908) 5mg/10mg | 0 | |
| Overall Study | NOT COMPLETED | Pradigastat (LCQ908) 10mg/20mg | 5 |
Source ClinicalTrials.gov
Adverse events348
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 | ANISOCYTOSIS | Blood and lymphatic system disorders | Placebo | 0 | 20 | |
| other | ANISOCYTOSIS | Blood and lymphatic system disorders | Pradigastat (LCQ908) 5mg /10 mg | 1 | 11 | |
| other | ANISOCYTOSIS | Blood and lymphatic system disorders | Pradigastat (LCQ908) 10mg/20 mg | 0 | 21 | |
| other | ANISOCYTOSIS | Blood and lymphatic system disorders | Pooled Pradigastat (LCQ908) | 1 | 32 | |
| other | PALPITATIONS | Cardiac disorders | Placebo | 1 | 20 | |
| other | PALPITATIONS | Cardiac disorders | Pradigastat (LCQ908) 5mg /10 mg | 0 | 11 | |
| other | PALPITATIONS | Cardiac disorders | Pradigastat (LCQ908) 10mg/20 mg | 0 | 21 | |
| other | PALPITATIONS | Cardiac disorders | Pooled Pradigastat (LCQ908) | 0 | 32 | |
| other | CONJUNCTIVITIS ALLERGIC | Eye disorders | Placebo | 1 | 20 | |
| other | CONJUNCTIVITIS ALLERGIC | Eye disorders | Pradigastat (LCQ908) 5mg /10 mg | 0 | 11 |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pradigastat (LCQ908) 5mg /10 mg | ||
| Total, all-cause mortality | Pradigastat (LCQ908) 10mg/20 mg | ||
| Total, all-cause mortality | Pooled Pradigastat (LCQ908) | ||
| Total, other adverse events | Placebo | 14 | 20 |
| Total, other adverse events | Pradigastat (LCQ908) 5mg /10 mg | 9 | 11 |
| Total, other adverse events | Pradigastat (LCQ908) 10mg/20 mg | 20 | 21 |
| Total, other adverse events | Pooled Pradigastat (LCQ908) | 29 | 32 |
| Total, serious adverse events | Placebo | 3 | 20 |
| Total, serious adverse events | Pradigastat (LCQ908) 5mg /10 mg | 1 | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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