Trial · NCT02912260
Outcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline To Week 12 In Hepatic Fat Fraction Assessed By Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) | Week 12 | MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Of Participants With Adverse Events (AEs) | Week 12 and Week 36 | Safety population: all randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline To Week 36 In Hepatic Fat Fraction Assessed By MRI-PDFF | Week 36 | Modified Intent-to-Treat (mITT) population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Week 12 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF | Week 12 | MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit. | percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Week 36 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Of Participants With At Least 30% Relative Fat Reduction at Week 12 | Week 12 | MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants With At Least 30% Relative Fat Reduction At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Achieving A 1-Point Reduction In Non-alcoholic Fatty Liver Disease Activity Score (NAS) At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Achieving A 2-Point Reduction In NAS At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Achieving A 2-Point Reduction In NAS And Either A ≥1-Point Reduction In Lobular Inflammation Or Hepatocellular Ballooning At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Achieving A 2-Point Reduction In NAS Without Fibrosis Worsening At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants With A Reduction In Hepatocellular Steatosis At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants With A Reduction In Lobular Inflammation At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants With A Reduction In Hepatocellular Ballooning At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Achieving NASH Resolution With At Least 2-Point Reduction In NAS At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline To Week 12 In High-sensitivity C-reactive Protein (hsCRP) | Week 12 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline To Week 36 In hsCRP | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Week 12 In Serum Alanine Aminotransferase (ALT) | Week 12 | MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit. | IU/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Week 36 In ALT | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits | IU/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Week 12 In Serum Aspartate Aminotransferase (AST) | Week 12 | MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit. | IU/L | LEAST_SQUARES_MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT02912260/outcomes