Trial · NCT05089084
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG) | Baseline, Month 10 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and Month 10. | percentage change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Fasting TG at Month 10 and Month 12 (Averaged) | Baseline, Month 10, Month 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and Months 10 and 12. | percentage change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein C-III (APOC3) at Month 10 | Baseline, Month 10 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and Month 10. | percentage change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Fasting APOC3 at Month 12 | Baseline, Month 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and Month 12. | percentage change | MEDIAN |
| SECONDARY | Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Randomized Period) | From first dose of study drug through Month 12 (Randomized Period) | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. The Statistical Analysis Plan pre-specified that the ARO-APOC3 25 mg and 50 mg groups were to be pooled together to be compared with placebo for the Randomized Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Open-Label Period) | From first dose of study drug through Month 36 (Open-Label Period) | |||
| SECONDARY | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Month 10 | Baseline, Month 10 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. A pattern-mixture model is used as the imputation method for the missing values of Month 10 in fasting non-HDL-Cs. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Month 12 | Baseline, Month 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. A pattern-mixture model is used as the imputation method for the missing values of Month 12 in fasting non-HDL-Cs. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Month 10 | Baseline, Month 10 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. A pattern-mixture model is used as the imputation method for the missing values of Month 10 in fasting HDL-Cs. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in HDL-C at Month 12 | Baseline, Month 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. A pattern-mixture model is used as the imputation method for the missing values of Month 12 in fasting HDL-Cs. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Fasting Triglycerides (TG) at Month 12 | Baseline, Month 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. A pattern-mixture model is used as the imputation method for the missing values of Month 12 in fasting non-HDL-Cs. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Fasting TG of <500, 880, and 1000 mg/dL at Month 10 | Month 10 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Observed cases. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Fasting TG of <500, 880, and 1000 mg/dL at Month 12 | Month 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Observed cases. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ≥40% and ≥70% Reduction From Baseline in Fasting TG at Month 10 | Baseline, Month 10 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and Month 10. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting TG Over Time | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and given timepoint. | mg/dL | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting TG Over Time | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and given timepoint. | percentage change | MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs; Randomized Period) | From first dose of study drug through Month 12 (Randomized Period) | Safety Analysis Set: all randomized participants who received at least 1 dose of study drug, analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent AEs and/or SAEs (Open-Label Period) | From first dose of open-label study drug through Month 36 (Open-Label Period) |
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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