Trial · NCT01811472
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline in Body Weight | Baseline, 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 both baseline and post-baseline values at different timepoints were included in this endpoint analysis | kilogram (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Waist Circumference | Baseline, 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 both baseline and post-baseline values at different timepoints were included in this endpoint analysis | centimeter (cm) | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability | 24 weeks | Safety set (SAF) - All patients who received at least one dose of study drug and had at least 1 post-baseline safety assessment. | Patients | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01811472/outcomes