Trial · NCT03371355
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | μg/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, and ApoAI at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, 'number analyzed' (n) signifies participants evaluable for this outcome measure for each specified category. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Free Fatty Acid (FFA) at Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lipoprotein(a) (Lp[a]) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | nmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in ANGPTL3, TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, ApoAI, FFA, and Lp(a) at Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, 'n' signifies participants evaluable for this outcome measure for each specified category. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hemoglobin A1c (HbA1c) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Insulin at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | milli-international units per liter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in and HOMA-IR at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | index | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fructosamine at Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | μmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycated Albumin at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | grams per deciliter (g/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weight at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Weight, SBP and DBP at Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C6 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hepatic Fat Fraction (HFF) by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percentage (Hepatic Fat Fraction) | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Hepatic Fat Fraction (HFF) by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With HFF ≤ 8% by MRI-PDFF at the Primary Analysis Time Point | Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fatty Liver Index (FLI) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | index | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | units per liter (U/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.
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