Trial · NCT02912260
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | The primary endpoint was relative change in MRI-PDFF assessed hepatic fat fraction compared with placebo at Week 12 in participants who had both a baseline and Week 12 MRI-PDFF. Least squares (LS) mean was provided for the statistical comparison of MGL-3196 versus placebo. |
| Secondary | Percentage Of Participants With Adverse Events (AEs) | Week 12 and Week 36 | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. |
| Secondary | Percent Change From Baseline To Week 36 In Hepatic Fat Fraction Assessed By MRI-PDFF | Week 36 | The endpoint was relative change assessed hepatic fat fraction compared with placebo at Week 36. LS mean was provided for the statistical comparison of MGL-3196 versus placebo. |
| Secondary | Change From Baseline To Week 12 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF | Week 12 | The endpoint was change in MRI-PDFF assessed absolute hepatic fat fraction compared with placebo at Week 12. LS mean was provided for the comparison of MGL-3196 versus placebo. |
| Secondary | Change From Baseline To Week 36 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF | Week 36 | The endpoint was change in assessed absolute hepatic fat fraction compared with placebo at Week 36. LS mean was provided for the comparison of MGL-3196 versus placebo. |
| Secondary | Percentage Of Participants With At Least 30% Relative Fat Reduction at Week 12 | Week 12 | The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% at Week 12. |
| Secondary | Percentage Of Participants With At Least 30% Relative Fat Reduction At Week 36 | Week 36 | The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% at Week 36. |
| Secondary | Percentage Of Participants Achieving A 1-Point Reduction In Non-alcoholic Fatty Liver Disease Activity Score (NAS) At Week 36 | Week 36 | The NAS is a histologic scale for non-alcoholic steatohepatitis (NASH) activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 1-point or greater reduction in NAS. |
| Secondary | Percentage Of Participants Achieving A 2-Point Reduction In NAS At Week 36 | Week 36 | The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS. |
| 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 | The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS and a 1-point or greater reduction in lobular inflammation or hepatocellular ballooning. |
| Secondary | Percentage Of Participants Achieving A 2-Point Reduction In NAS Without Fibrosis Worsening At Week 36 | Week 36 | The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). Fibrosis stage (0 to 3) was also included in the assessment. The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS without worsening fibrosis. |
| Secondary | Percentage Of Participants With A Reduction In Hepatocellular Steatosis At Week 36 | Week 36 | The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in hepatocellular steatosis. |
| Secondary | Percentage Of Participants With A Reduction In Lobular Inflammation At Week 36 | Week 36 | The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in lobular inflammation. |
| Secondary | Percentage Of Participants With A Reduction In Hepatocellular Ballooning At Week 36 | Week 36 | The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in hepatocellular ballooning. |
| Secondary | Percentage Of Participants Achieving NASH Resolution With At Least 2-Point Reduction In NAS At Week 36 | Week 36 | The endpoint presented the percentage of participants achieving NASH resolution with a 2-point reduction at Week 36. |
| Secondary | Percent Change From Baseline To Week 12 In High-sensitivity C-reactive Protein (hsCRP) | Week 12 | hsCRP was used as a non-invasive inflammation marker for this study. Blood samples were collected to determine the effect of MGL-3196 on hsCRP. |
| Secondary | Percent Change From Baseline To Week 36 In hsCRP | Week 36 | hsCRP was used as a non-invasive inflammation marker for this study. Blood samples were collected to determine the effect of MGL-3196 on hsCRP. |
| Secondary | Change From Baseline To Week 12 In Serum Alanine Aminotransferase (ALT) | Week 12 | Blood samples were collected to determine the effect of MGL-3196 on serum ALT. |
| Secondary | Change From Baseline To Week 36 In ALT | Week 36 | Blood samples were collected to determine the effect of MGL-3196 on serum ALT. |
| Secondary | Change From Baseline To Week 12 In Serum Aspartate Aminotransferase (AST) | Week 12 | Blood samples were collected to determine the effect of MGL-3196 on serum AST. |
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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