Trial · NCT04568434
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Fasting TG at Month 6 | Baseline, Month 6 | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Fasting TG at Month 12 | Baseline, Month 12 | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Apolipoprotein C-III (apoC-III) at Months 6 and 12 | Baseline, Months 6 and 12 | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With ≥ 40% Reduction in Fasting TG at Month 6 | Month 6 | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Fasting Apolipoprotein B-48 (apoB-48) at Months 6 and 12 | Baseline, Months 6 and 12 | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Months 6 and 12 | Baseline, Months 6 and 12 | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | percent change | LEAST_SQUARES_MEAN |
| 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 | During the treatment period Week 1 through Week 53 | 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) | events per 100 participant-years | MEAN |
| SECONDARY | Adjudicated Acute Pancreatitis Mean Event Rate Per 100 Participant-Years During the Treatment Period (Week 1 Through Week 53) | During the treatment period Week 1 through Week 53 | 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). | events per 100 participant-years | MEAN |
| SECONDARY | Adjudicated Acute Pancreatitis Mean Event Per 100 Participant-Years Rate During Week 13 Through Week 53 in Participants With Prior History of Pancreatitis | Week 13 through Week 53 | 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). | events per 100 participant-years | MEAN |
| SECONDARY | Adjudicated Acute Pancreatitis Mean Event Rate Per 100 Participant-Years During Week 13 to Week 53 | Week 13 through Week 53 | 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). | events per 100 participant-years | MEAN |
| SECONDARY | Percentage of Participants With ≥ 70% Reduction in Fasting TG at Month 6 | Month 6 | FAS included all participants that were randomly assigned to treatment and received at least 1 dose of olezarsen or placebo. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Fasting TG ≤ 880 mg/dL at Month 6 | Month 6 | 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. | percentage of participants | NUMBER |
| 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 | During the treatment period Week 1 through Week 53 | 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). | events per 100 participant-years | MEAN |
| 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 | Week 13 to Week 53 | 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). | events per 100 participant-years | MEAN |
| SECONDARY | Percentage of Participants With Fasting TG ≤ 500 mg/dL at Month 6 | Month 6 | 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. | percentage of participants | NUMBER |
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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