| Primary | Percent Change From Baseline in Fasting TG at Month 6 | | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Olezarsen 50 mg | Participants received olezarsen 50 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG002 | Olezarsen 80 mg | Participants received olezarsen 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00011.52(-5.321 to 28.356)
- OG001-10.85(-27.797 to 6.095)
- OG002-31.99(-49.031 to -14.940)
|
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| | 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 | | =0.0009 | ANCOVA model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate. | LS mean difference | -43.5 | | | 2-Sided | 95 | -69.085 | -17.921 | | | | | Superiority | | | |
|
| Secondary | Percent Change From Baseline in Fasting TG at Month 12 | | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Olezarsen 50 mg | Participants received olezarsen 50 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG002 | Olezarsen 80 mg | Participants received olezarsen 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
| |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein C-III (apoC-III) at Months 6 and 12 | | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Olezarsen 50 mg | Participants received olezarsen 50 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG002 | Olezarsen 80 mg | Participants received olezarsen 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
| |
| Secondary | Percentage of Participants With ≥ 40% Reduction in Fasting TG at Month 6 | Percentages are rounded off to the nearest single decimal place. | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | Posted | | Number | | percentage of participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Olezarsen 50 mg | Participants received olezarsen 50 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG002 | Olezarsen 80 mg | Participants received olezarsen 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
| |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein B-48 (apoB-48) at Months 6 and 12 | | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Olezarsen 50 mg | Participants received olezarsen 50 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG002 | Olezarsen 80 mg | Participants received olezarsen 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
| |
| Secondary | Percent Change From Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Months 6 and 12 | | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Olezarsen 50 mg | Participants received olezarsen 50 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG002 | Olezarsen 80 mg | Participants received olezarsen 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
| |
| Secondary | Adjudicated Acute Pancreatitis Mean Event Rate Per 100 Participant-Years During the Treatment Period (Week 1 Through Week 53) in Participants With Prior History of Pancreatitis | All AEs and SAEs that consistently occurred during the study with an event of acute pancreatitis were adjudicated by a blinded, independent committee according to the Atlanta classification of acute pancreatitis as outlined in the Acute Pancreatitis Adjudication Committee (PAC) Charter. These events were categorized as 1) documented pancreatitis, 2) probable pancreatitis, 3) possible pancreatitis, 4) unable to adjudicate and 5) no diagnosis of acute pancreatitis. The adjudicated event rate represents the average number of events per 100 participant-years during the treatment period. | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. Overall number of participants analyzed is the number of participants with a history of pancreatitis within 10 years prior to screening. As prespecified in the protocol, data for this outcome measure was collected and reported in a pooled manner for olezarsen (combined Olezarsen 50 mg + Olezarsen 80 mg) | Posted | | Mean | 95% Confidence Interval | events per 100 participant-years | | During the treatment period Week 1 through Week 53 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Pooled Olezarsen |
|
| Secondary | Adjudicated Acute Pancreatitis Mean Event Rate Per 100 Participant-Years During the Treatment Period (Week 1 Through Week 53) | All AEs and SAEs that consistently occurred during the study with an event of acute pancreatitis were adjudicated by a blinded, independent committee according to the Atlanta classification of acute pancreatitis as outlined in the PAC Charter. These events were categorized as 1) documented pancreatitis, 2) probable pancreatitis, 3) possible pancreatitis, 4) unable to adjudicate and 5) no diagnosis of acute pancreatitis. The adjudicated event rate represents the average number of events per 100 participant-years during the treatment period. | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. As prespecified in the protocol, data for this outcome measure was collected and reported in a pooled manner for olezarsen (combined Olezarsen 50 mg + Olezarsen 80 mg). | Posted | | Mean | 95% Confidence Interval | events per 100 participant-years | | During the treatment period Week 1 through Week 53 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Pooled Olezarsen | Participants received olezarsen 50 mg or 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
|
| Secondary | Adjudicated Acute Pancreatitis Mean Event Per 100 Participant-Years Rate During Week 13 Through Week 53 in Participants With Prior History of Pancreatitis | All AEs and SAEs that consistently occurred during the study with an event of acute pancreatitis were adjudicated by a blinded, independent committee according to the Atlanta classification of acute pancreatitis as outlined in the PAC Charter. These events were categorized as 1) documented pancreatitis, 2) probable pancreatitis, 3) possible pancreatitis, 4) unable to adjudicate and 5) no diagnosis of acute pancreatitis. The adjudicated event rate represents the average number of events per 100 participant-years during the specified duration. | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. Overall number of participants analyzed is the number of participants with a history of pancreatitis within 10 years prior to screening. As prespecified in the protocol, data for this outcome measure was collected and reported in a pooled manner for olezarsen (combined Olezarsen 50 mg + Olezarsen 80 mg). | Posted | | Mean | 95% Confidence Interval | events per 100 participant-years | | Week 13 through Week 53 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Pooled Olezarsen | Participants received olezarsen 50 mg or 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
|
| Secondary | Adjudicated Acute Pancreatitis Mean Event Rate Per 100 Participant-Years During Week 13 to Week 53 | All AEs and SAEs that consistently occurred during the study with an event of acute pancreatitis were adjudicated by a blinded, independent committee according to the Atlanta classification of acute pancreatitis as outlined in the PAC Charter. These events were categorized as 1) documented pancreatitis, 2) probable pancreatitis, 3) possible pancreatitis, 4) unable to adjudicate and 5) no diagnosis of acute pancreatitis. The adjudicated event rate represents the average number of events per 100 participant-years during the specified duration. | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. As prespecified in the protocol, data for this outcome measure was collected and reported in a pooled manner for olezarsen (combined Olezarsen 50 mg + Olezarsen 80 mg). | Posted | | Mean | 95% Confidence Interval | events per 100 participant-years | | Week 13 through Week 53 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Pooled Olezarsen | Participants received olezarsen 50 mg or 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
| |
| Secondary | Percentage of Participants With ≥ 70% Reduction in Fasting TG at Month 6 | Percentages are rounded off to the nearest single decimal place. | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | Posted | | Number | | percentage of participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Olezarsen 50 mg | Participants received olezarsen 50 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG002 | Olezarsen 80 mg | Participants received olezarsen 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
| |
| Secondary | Percentage of Participants With Fasting TG ≤ 880 mg/dL at Month 6 | Percentages are rounded off to the nearest single decimal place. | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. "Overall number of participants analyzed" indicates the number of participants with data available for analyses. | Posted | | Number | | percentage of participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Olezarsen 50 mg | Participants received olezarsen 50 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG002 | Olezarsen 80 mg | Participants received olezarsen 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
| |
| Secondary | Adjudicated Acute Pancreatitis Mean Event Rate Per 100 Participant-Years During Treatment Period in Participants With ≥ 2 Events in 5 Years Prior to Enrollment | All AEs and SAEs that consistently occurred during the study with an event of acute pancreatitis were adjudicated by a blinded, independent committee according to the Atlanta classification of acute pancreatitis as outlined in the PAC Charter. These events were categorized as 1) documented pancreatitis, 2) probable pancreatitis, 3) possible pancreatitis, 4) unable to adjudicate and 5) no diagnosis of acute pancreatitis. The adjudicated event rate represents the average number of events per 100 participant-years during the treatment period. | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. Overall number of participants analyzed is the number of participants with ≥ 2 adjudicated acute pancreatitis events in 5 years prior to enrollment. As prespecified in the protocol, data for this outcome measure was collected and reported in a pooled manner for olezarsen (combined Olezarsen 50 mg + Olezarsen 80 mg). | Posted | | Mean | 95% Confidence Interval | events per 100 participant-years | | During the treatment period Week 1 through Week 53 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Pooled Olezarsen | |
|
| Secondary | Adjudicated Acute Pancreatitis Mean Event Rate Per 100 Participant-Years From Week 13 to Week 53 in Participants With ≥ 2 Events in 5 Years Prior to Enrollment | All AEs and SAEs that consistently occurred during the study with an event of acute pancreatitis were adjudicated by a blinded, independent committee according to the Atlanta classification of acute pancreatitis as outlined in the PAC Charter. These events were categorized as 1) documented pancreatitis, 2) probable pancreatitis, 3) possible pancreatitis, 4) unable to adjudicate and 5) no diagnosis of acute pancreatitis. The adjudicated event rate represents the average number of events per 100 participant-years during the specified duration. | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. Overall number of participants analyzed is the number of participants with ≥ 2 adjudicated acute pancreatitis events in 5 years prior to enrollment. As prespecified in the protocol, data for this outcome measure was collected and reported in a pooled manner for olezarsen (combined Olezarsen 50 mg + Olezarsen 80 mg). | Posted | | Mean | 95% Confidence Interval | events per 100 participant-years | | Week 13 to Week 53 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Pooled Olezarsen | Participants received olezarsen 50 mg or 80 mg, once every 4 weeks by SC injection during Weeks 1 to 49 of the 53-week treatment period. |
|
| Secondary | Percentage of Participants With Fasting TG ≤ 500 mg/dL at Month 6 | Percentages are rounded off to the nearest single decimal place. | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. 'Overall number of participants analyzed' indicates the number of participants with data available for the analyses. | Posted | | Number | | percentage of participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received olezarsen-matching placebo, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG001 | Olezarsen 50 mg | Participants received olezarsen 50 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. | | OG002 | Olezarsen 80 mg | Participants received olezarsen 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period. |
| |