Trial · NCT02442687
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population) | Baseline to week 24 | |
| Primary | Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population) | Baseline to Week 12 | |
| Secondary | Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population) | Baseline to week 24 | |
| Secondary | Analysis of ALT Change From Baseline to Week 12 (Per Protocol Population) | Baseline to week 12 | |
| Secondary | Time to Remission (in Weeks) | 24 weeks | Time to remission is the time in weeks from randomization to liver function remission, defined as two consecutive ALT values within normal range (\<40 U/L) during the treatment period. |
| Secondary | Change in BMI (Body Mass Index) | Baseline, week 24 | |
| Secondary | Change in Hemoglobin A1C | Baseline, week 24 | |
| Secondary | Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline, week 24 | HOMA-IR was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. Optimal Range: 1.0 (0.5-1.4). Lower values represent a better outcome. |
| Secondary | Percent Change in Cholesterol | Baseline, week 24 | |
| Secondary | Percent Change in Triglycerides | Baseline, week 24 | |
| Secondary | Percent Change in Low Density Lipoprotein (LDL) Cholesterol | Baseline, week 24 | |
| Secondary | Percent Change in High Density Lipoprotein (HDL) | Baseline, week 24 | |
| Secondary | Mean Serum Aspartate Aminotransferase (AST) | weeks 4, 8, 12, 16, 20, and 24 | |
| Secondary | Mean Serum Alanine Aminotransferase (ALT) | weeks 4, 8, 12, 16, 20, and 24 | |
| Secondary | Mean Serum Gamma-glutamyl Transpeptidase (GGT) | weeks 4, 8, 12, 16, 20, and 24 | |
| Secondary | Number of Subjects With ALT in Normal Range at Week 24 | Week 24 | Normal range is \<40 U/L |
| Secondary | Maximum Observed Concentrations (Cmax) | pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours | |
| Secondary | Minimum Observed Concentration (Cmin) | pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours | |
| Secondary | Area Under Concentration-time (AUC) | pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours | |
| Secondary | Half-life | pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours |
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/NCT02442687/registered