Trial · NCT03452228
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Fasting Triglycerides (TG) Level Following 12 Weeks of Repeated IV Doses of Evinacumab in Actual Cohort 3 Participants | Participants randomized to evinacumab: Week 0 corresponds to Baseline and 12 weeks treatment corresponds to Week 12 of the DBTP; Participants randomized to placebo: Week 12 corresponds to Baseline and 12 weeks treatment corresponds to Week 24 of the SBTP | The FAS included all randomized participants who received any double-blind study drug based on the treatment assigned (as randomized). Mixed-effect Model for Repeated Measures (MMRM) method assessed within-patient treatment comparisons (using an unstructured covariance matrix), while accounting for baseline TG, study visit, and baseline TG by study visit interaction. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | DBTP: Baseline, Weeks 2, 4, 6, 8, 12; SBTP: Weeks 16, 20, and 24 | The FAS included all randomized participants who received any double-blind study drug based on the treatment assigned (as randomized). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period and number analyzed signifies to participants evaluable for this outcome at given timepoints. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab in Actual Cohorts 1, 2, and 3 | Weeks 2, 4, 6, 8, 12, 16, 20, and 24 | The FAS included all randomized participants who received any double-blind study drug based on the treatment assigned (as randomized). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period and number analyzed signifies to participants evaluable for this outcome at given timepoints. | Percent Change | MEDIAN |
| SECONDARY | Change From Baseline in Total Score of Participants Reported Abdominal and Gastrointestinal (GI) Symptoms Using Hypertriglyceridemia and Acute Pancreatitis Symptom Scale (HAP-SS) | Baseline, Week 12 (DBTP), Week 24 (SBTP) | Patient-reported outcomes (PRO) analysis set included all randomized participants who received any double-blind study treatment with a baseline and at least 1 non-missing post-baseline PRO evaluation. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline in Total Score of Participants Reported Dietary Behavior Questionnaire (HAP-DB) | Baseline, Week 12 (DBTP), Week 24 (SBTP) | PRO analysis set includes all randomized participants who received any double-blind study treatment with a baseline and at least 1 non-missing post-baseline PRO evaluation. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period. | Score on a Scale | MEAN |
| SECONDARY | DBTP: Change From Baseline in Degree of Pancreatic Injury/Inflammation Through 18F-2-Fluoro-2-Deoxy-D Glucose Positron Emission Tomography (18F-FDG-PET) Imaging Following 12 Weeks of Treatment With Evinacumab Assessed by 18F-FDG SUVmax and SUVmean | Participants randomized to evinacumab: Week 0 corresponds to Baseline and 12 weeks treatment corresponds to Week 12 of the DBTP; Participants randomized to placebo: Week 12 corresponds to Baseline and 12 weeks treatment corresponds to Week 24 of the SBTP | PET analysis set included all randomized participants who received any double-blind study treatment with a baseline and a post-baseline (positron emission tomography) PET evaluation. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period. | gram/milliliter (g/ml) | MEAN |
| SECONDARY | DBTP: Change From Baseline in Degree of Pancreatic Injury/Inflammation Through Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI) Following 12 Weeks of Treatment With Evinacumab Assessed by Apparent Diffusion Coefficient (ADC) | Participants randomized to evinacumab: Week 0 corresponds to Baseline and 12 weeks treatment corresponds to Week 12 of the DBTP; Participants randomized to placebo: Week 12 corresponds to Baseline and 12 weeks treatment corresponds to Week 24 of the SBTP | Magnetic resonance imaging (MRI) analysis set included all randomized participants who received any double-blind study treatment with a baseline and at least 1 post-baseline MRI evaluation. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period and number analyzed signifies to participants evaluable for this outcome at given timepoints. | Square-millimeters per second (mm^2/sec) | MEAN |
| SECONDARY | SBTP: Change From Baseline to Degree of Pancreatic Injury/Inflammation Through DW-MRI Following 24 Weeks of Treatment With Evinacumab as Assessed by ADC | Baseline (Week 0 DBTP), Week 24 (SBTP) | MRI analysis set included all randomized participants who received any double-blind study treatment with a baseline and at least 1 post-baseline MRI evaluation. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period. | mm^2/sec | MEAN |
| SECONDARY | Total Evinacumab Concentration in Serum | Up to 44 weeks | Pharmacokinetic (PK) analysis set included all randomized participants who received any study drug and have at least 1 non-missing measurement of evinacumab concentration following the first dose of the study drug. Here, number analyzed signifies to participants evaluable for this outcome at given timepoints. | milligram per liter (mg/L) | MEAN |
| SECONDARY | Total Angiopoietin-like (ANGPTL3) Concentration in Serum | Up to 44 weeks | The total target analysis set is defined as all randomized participants who received any study drug and have at least 1 non-missing measurement of total ANGPTL3 concentration following the first dose of study drug. Here, number analyzed signifies to participants evaluable for this outcome at given timepoints. | mg/L | MEAN |
| SECONDARY | Number of Participants With Antidrug Antibodies (ADA) | Up to 44 weeks | The ADA analysis set included all randomized participants who received any study drug and had at least 1 non-missing ADA result following the first dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBTP: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From first dose of DB treatment to day of last dose of DB treatment + 24 weeks (if not proceeding to SBTP) or up to day before first dose of SB treatment in SBTP | The double-blind safety analysis set considered for safety analyses included the randomized population who received at least 1 dose or part of a dose of double-blind study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | SBTP: Number of Participants With TEAEs and Serious TEAEs | From day of first SB study treatment to day of last SB treatment + 24 weeks | The single-blind safety analysis set considered for safety analyses included the randomized population who received at least 1 dose or part of a dose of single-blind study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Liver Function Laboratory Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Total Bilirubin | Baseline up to 44 weeks | The double-blind safety analysis set considered for safety analyses included the randomized population who received at least 1 dose or part of a dose of double-blind study drug. The single-blind safety analysis set considered for safety analyses included the randomized population who received at least 1 dose or part of a dose of single-blind study drug. | Participants | COUNT_OF_PARTICIPANTS |
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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