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Trial · NCT03508687

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Fasting Serum Triglyceride (at 12 Weeks)Baseline to week 12This is measured by percent change in fasting serum triglyceride from baseline to week 12
SecondaryChange in Fasting Serum Triglycerides (Through 24 Weeks)Baseline, week 6 and week 12, week 24This is measured by change in fasting serum triglyceride from baseline to average of weeks 6 and 12, and week 24 and change in fasting serum triglyceride from baseline to week 12
SecondaryPercent Change in Fasting Serum Triglycerides (Through 24 Weeks)Baseline, week 6 and week 12, week 24This is measured by percent change in fasting serum triglyceride from baseline to average of weeks 6 and 12, and week 24 and change in fasting serum triglyceride from baseline to week 12
SecondaryChange in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF)Baseline, week 12, week 24This is measured by change in liver fat content using Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) from baseline to week 12 and week 24
SecondaryPercent Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF)Baseline, week 12, week 24This is measured by percent change in liver fat content using Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) from baseline to week 12 and week 24
SecondaryChange in Liver FibrosisBaseline, Week 12, and Week 24This is measured by change in liver fibrosis using MR-elastography from baseline to week 12 and week 24
SecondaryPercent Change in Liver FibrosisBaseline, Week 12, and Week 24This is measured by percent change in liver fibrosis using MR-elastography from baseline to week 12 and week 24
SecondaryChange in NAS (Non-alcoholic Steatohepatitis)Baseline to week 24
This is measured by change in NAS via non-alcoholic fatty liver disease activity score. NAS is the unweighted sum of steatosis, lobular inflammation and hepatocyte ballooning from baseline to week 24. Total NAS scores can range from 0 to 8. The higher the NAS score, the more severe the liver disease.
SecondaryPercent Change in NAS (Non-alcoholic Steatohepatitis)Baseline to week 24
This is measured by change in NAS via non-alcoholic fatty liver disease activity score. NAS is the unweighted sum of steatosis, lobular inflammation and hepatocyte ballooning from baseline to week 24. Total NAS scores can range from 0 to 8. The higher the NAS score, the more severe the liver disease.
SecondaryChange in CholesterolBaseline, week 6 and week 12, week 24This will be measured by change in total, HDL and LDL levels in mg/dL
SecondaryPercent Change in CholesterolBaseline, week 6 and week 12, week 24This will be measured as percent change in total, HDL and LDL levels in mg/dL.
SecondaryChange in ApolipoproteinBaseline, week 6 and week 12, week 24This will be measured by change in apolipoprotein A and B in mg/dL
SecondaryPercent Change in ApolipoproteinBaseline, week 6 and week 12, week 24This will be measured by percent change in apolipoprotein A and B in mg/dL
SecondaryChange in High-Sensitivity C-Reactive Protein (hsCRP)Baseline, week 12, week 24This is measured by change in high-sensitivity C-reactive protein (hsCRP) from baseline to weeks 12 and week 24
SecondaryPercent Change in High-Sensitivity C-Reactive Protein (hsCRP)Baseline, week 12, week 24This is measured by percent change in high-sensitivity C-reactive protein (hsCRP) from baseline to weeks 12 and week 24
SecondaryChange in Alanine Aminotransferase (ALT)Baseline, week 12, week 24This is measured by change in alanine aminotransferase (ALT) from baseline to weeks 12 and week 24
SecondaryPercent Change in Alanine Aminotransferase (ALT)Baseline, week 12, week 24This is measured by percent change in alanine aminotransferase (ALT) from baseline to weeks 12 and week 24
SecondaryChange in Aspartate Aminotransferase (AST)Baseline, week 12, week 24This is measured by change in aspartate aminotransferase (AST) from baseline to weeks 12 and week 24
SecondaryPercent Change in Aspartate Aminotransferase (AST)Baseline, week 12, week 24This is measured by percent change in aspartate aminotransferase (AST) from baseline to weeks 12 and week 24

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.

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