| Primary | Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point | 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. | FAS population included all participants who were randomized and received at least 1 dose of study drug. | Posted | | Geometric Mean | 95% Confidence Interval | percent change | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | Participants received ISIS 703802, 20 mg SC once every week for 26 doses. |
| | Units | Counts |
|---|
| Participants | - OG00027
- OG00126
- OG00226
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-16(-29 to 0)
- OG001-36(-47 to -23)
- OG002-53(-60 to -43)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.0343 | | Mean Difference in % CFB | -24 | | | 2-Sided | 95 | -41 | -2 | | | Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated. | | Superiority | | | | |
|
| Secondary | Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | μg/L | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | Participants received ISIS 703802, 20 mg SC once every week for 26 doses. |
|
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | |
|
| Secondary | Change From Baseline in Free Fatty Acid (FFA) at Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | mmol/L | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | Participants received ISIS 703802, 20 mg SC once every week for 26 doses. |
|
| Secondary | Change From Baseline in Lipoprotein(a) (Lp[a]) at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | nmol/L | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | Participants received ISIS 703802, 20 mg SC once every week for 26 doses. |
|
| 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 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | percent change | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. |
|
| Secondary | Change From Baseline in Fasting Plasma Glucose at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | Participants received ISIS 703802, 20 mg SC once every week for 26 doses. |
|
| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of HbA1c | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | |
|
| Secondary | Change From Baseline in Fasting Insulin at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | milli-international units per liter | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | |
|
| Secondary | Change From Baseline in and HOMA-IR at the Primary Analysis Time Point | 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | index | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | |
|
| Secondary | Change From Baseline in Fructosamine at Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | μmol/L | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | Participants received ISIS 703802, 20 mg SC once every week for 26 doses. |
|
| Secondary | Change From Baseline in Glycated Albumin at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | grams per deciliter (g/dL) | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | |
|
| Secondary | Change From Baseline in Weight at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | kg | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | Participants received ISIS 703802, 20 mg SC once every week for 26 doses. |
|
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | millimeters of mercury (mmHg) | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | |
|
| Secondary | Percent Change From Baseline in Weight, SBP and DBP at Primary Analysis Time Point | An ANCOVA model was performed on the percent change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C6 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | |
|
| 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 | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage (Hepatic Fat Fraction) | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW |
|
| 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 | An ANCOVA model was performed on the percent change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW |
|
| Secondary | Percentage of Participants With HFF ≤ 8% by MRI-PDFF at the Primary Analysis Time Point | 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. | 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. | Posted | | Number | | percentage of participants | | Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW |
|
| Secondary | Change From Baseline in Fatty Liver Index (FLI) at the Primary Analysis Time Point | 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | index | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. |
|
| Secondary | Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | units per liter (U/L) | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW |
|
| Secondary | Change From Baseline in Leptin at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | μg/L | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | Participants received ISIS 703802, 20 mg SC once every week for 26 doses. |
|
| Secondary | Change From Baseline in Adiponectin at the Primary Analysis Time Point | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | milligrams per liter (mg/L) | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | |
|
| Secondary | Change From Baseline in Subcutaneous Adipose Tissue (SAT) and Visceral Adipose Tissue (VAT) by Single Slice MRI at the Primary Analysis Timepoint | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | mm^2 | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | |
|
| Secondary | Change From Baseline in Waist Circumference by Single Slice MRI at the Primary Analysis Timepoint | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | cm | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg Q4W | |
|
| Secondary | Change From Baseline in Waist to Hip Ratio (WHR) at the Primary Analysis Timepoint | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | ratio | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | Participants received ISIS 703802, 20 mg SC once every week for 26 doses. |
|
| Secondary | Change From Baseline in Body Mass Index (BMI) at the Primary Analysis Timepoint | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. | 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 | Posted | | Least Squares Mean | 95% Confidence Interval | kg/m^2 | | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 mg SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 | Cohort A: ISIS 703802, 20 mg QW | Participants received ISIS 703802, 20 mg SC once every week for 26 doses. |
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE was defined as any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. TEAEs were defined as adverse events that occurred after the first administration of study drug. | Safety set included all participants who were randomized and received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | Up to 13 weeks post treatment period (up to 39 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants from each cohort received placebo at a dose-matched volume of study drug, SC. | | OG001 | Cohort B: ISIS 703802, 40 mg Q4W | Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses. | | OG002 | Cohort C: ISIS 703802, 80 mg Q4W | Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses. | | OG003 |
|