Trial · NCT03371355
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | An ANCOVA model was performed on the log ratio of Primary Analysis Time Point to Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Primary Analysis Time Point to Baseline - 1) × 100. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the log ratio of Primary Analysis Time Point to Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Primary Analysis Time Point to Baseline - 1) × 100. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | HOMA-IR is a method used to quantify insulin resistance. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/mL) \* fasting plasma glucose (mmol/L)/22.5. A negative change from Baseline indicates improvement. An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the percent change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the percent change from Baseline to Primary Analysis Time Point. |
| 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 | The percentage of participants who achieved HFF ≤ 8% at the Primary Analysis Time Point was compared between each ISIS 703802 treatment group and pooled placebo group using a logistic regression model. |
| 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 | The FLI was calculated by the following formula: FLI =(e0.953×loge\[triglycerides\]+0.139× Body Mass Index \[BMI\]+0.718×loge Gamma- Glutamyl Transferase \[GGT\]+0.053×waistcircumference-15.745)/ (1 + e0.953×loge\[triglycerides\]+0.139×BMI+0.718×loge \[GGT\]+0.053×waistcircumference-15.745) × 100. An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
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
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