| Secondary | Percent Change in Apolipoprotein C3 (ApoC3) From Baseline to Week 52 | Apolipoproteins transport lipids through the body by binding with fat and cholesterol to form lipoproteins. ApoC3 was a component of very-low-density lipoproteins (VLDL), high-density lipoprotein (HDL), and triglyceride-rich chylomicrons and regulates lipid metabolism. Percent change in ApoC3 from Baseline to Week 52 was reported. | ITT population was defined as all randomized participants who received 1 dose or part of a dose of study drug. Here, "Overall number of participants analyzed" refers to participants who were evaluable for this outcome measure and "0" in the overall analyzed field signifies that none of the participants were available for the assessment at the specified timepoint for placebo arm. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Randomized 1:1 Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Randomized 1:1 Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Percent Change in Fasting Triglycerides (TGs) - (From Baseline to Week 52) | | The ITT population is defined as all randomized participants who received 1 dose or part of a dose of study drug. Participants in the ITT population will be analyzed according to the treatment group allocated by randomization. Participants who were evaluable for this outcome measure and "0" in the overall analyzed field signifies that none of the participants were available for the assessment at the specified timepoint for placebo arm. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Randomized 1:1 Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Randomized 1:1 Randomized 1:1 Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Percent Change in Total Cholesterol (TC) - (Baseline to Week 52) | | ITT population was defined as all randomized participants who received 1 dose or part of a dose of study drug. Here, "Overall number of participants analyzed" refers to participants who were evaluable for this outcome measure and "0" in the overall analyzed field signifies that none of the participants were available for the assessment at the specified timepoint for placebo arm. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Randomized 1:1 Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Randomized 1:1 Randomized 1:1 Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) - (From Baseline to Week 52) | | ITT population was defined as all randomized participants who received 1 dose or part of a dose of study drug. Here, "Overall number of participants analyzed" refers to participants who were evaluable for this outcome measure and "0" in the overall analyzed field signifies that none of the participants were available for the assessment at the specified timepoint for placebo arm. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Randomized 1:1 Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks | | OG001 | Evinacumab | Randomized 1:1 Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Percent Change in Apolipoprotein B48 (ApoB48) From Baseline to Week 52 | | The ITT population is defined as all randomized participants who received 1 dose or part of a dose of study drug. Participants in the ITT population will be analyzed according to the treatment group allocated by randomization. Participants who were evaluable for this outcome measure and "0" in the overall analyzed field signifies that none of the participants were available for the assessment at the specified timepoint for placebo arm. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Randomized 1:1 Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Randomized 1:1 Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Percent Change in Apolipoprotein B100 (ApoB100) Levels From Baseline to Week 52 | | The ITT population is defined as all randomized participants who received 1 dose or part of a dose of study drug. Participants in the ITT population will be analyzed according to the treatment group allocated by randomization. Participants who were evaluable for this outcome measure and "0" in the overall analyzed field signifies that none of the participants were available for the assessment at the specified timepoint for placebo arm. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Randomized 1:1 Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Randomized 1:1 Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Percent Change in Nuclear Magnetic Resonance (NMR)-Determined Particle Size and Number From Baseline to Week 52 | | Data was not collected and analyzed for this outcome measure as the sponsor terminated the study early due to enrollment issues. | Posted | | | | | | Baseline to week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Randomized 1:1 Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Randomized 1:1 Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Number of Independently Adjudicated Positive Episodes of Acute Pancreatitis (AP) Per Participant | | The ITT population is defined as all randomized participants who received 1 dose or part of a dose of study drug. Participants in the ITT population will be analyzed according to the treatment group allocated by randomization | Posted | | Mean | Standard Deviation | Number of Episodes | | Up to 52 weeks | | | | ID | Title | Description |
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| OG000 | Placebo | Randomized 1:1 Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Randomized 1:1 Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Primary | Percentage of Participants With at Least One Positively Adjudicated Acute Pancreatitis (AP) Episode | All AP (Acute Pancreatitis) episodes occurred post-study drug treatment. | The Intent-to-treat Analysis Set (ITT) population was defined as all randomized participants who received 1 dose or part of a dose of study drug. | Posted | | Number | | Percentage of Participants | | Baseline to 52 weeks | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | | The SAF included all participants who received at least 1 dose or part of a dose of double-blind study drug. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to off drug follow-up (up to Week 72) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Number of Participants With TEAEs Based on Severity | AE was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. TEAEs are defined as AEs that developed or worsened during the treatment period. Severity of TEAEs was graded according to the following scale: Mild: Does not interfere in a significant manner with the participants normal functioning level, Moderate: Produces some impairment of functioning but is not hazardous to health and Severe: Produces significant impairment of functioning or incapacitation and is a definite hazard to the participants health. | The SAF included all participants who received at least 1 dose or part of a dose of double-blind study drug. Here, "Overall number of participants analyzed" refers to participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to off drug follow-up (up to Week 72) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters | Clinical laboratory parameters included biochemistry, hematology and urinalysis. The number of participants with clinically significant changes from baseline in laboratory parameters were reported. Clinical significance was determined by the investigator. | The SAF included all participants who received at least 1 dose or part of a dose of double-blind study drug. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to off drug follow-up (up to Week 72) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Number of Participants With Positive Treatment-emergent Anti-Drug Antibodies (ADA) | Treatment-Emergent ADA was defined as any positive post baseline assay response when baseline results were negative or missing. Treatment-Emergent ADA responses were further classified as: Persistent (a positive result in the ADA assay detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period [based on] nominal sampling time], with no ADA-negative results in-between, regardless of any missing samples); Indeterminate (a positive result in the ADA assay at the last collection time point only, regardless of any missing samples); Transient (not persistent/indeterminate, regardless of any missing samples). Number of participants with positive treatment-emergent ADA response during Week 52 were reported. | The ADA analysis set included all treated participants who received any amount of study drug (active or placebo) and had at least one non-missing ADA result following the first dose of the study drug or placebo. Here, "Overall number of participants analyzed" refers to participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Baseline to Week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Number of Participants With Positive Neutralizing Antibodies (NAb) | NAb positive was defined as presence of at least one positive nAb sample. | Data was not collected and analyzed for this outcome measure as the sponsor terminated the study early due to enrollment issues. | Posted | | | | | | Baseline to Week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Percent Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 | Percent Change in fasting HDL-C from Baseline to Week 52 was reported. | The SAF included all participants who received at least 1 dose or part of a dose of double-blind study drug. Here, "Overall number of participants analyzed" refers to participants who were evaluable for this outcome measure and "0" in the overall analyzed field signifies that none of the participants were available for the assessment at the specified timepoint for placebo arm. | Posted | | Mean | Standard Deviation | Percent change | | Baseline to Week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Percent Change in Fasting Low Density Lipoprotein (LDL-C) From Baseline to Week 52 | LDL-C levels were determined in beta-quantification with ultracentrifugation method. Percent change in fasting LDL-C from Baseline to Week 52 was reported. | The SAF included all participants who received at least 1 dose or part of a dose of double-blind study drug. Here, "Overall number of participants analyzed" refers to participants who were evaluable for this outcome measure and "0" in the overall analyzed field signifies that none of the participants were available for the assessment at the specified timepoint for placebo arm. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to Week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Concentration of Total Evinacumab in Serum | Concentration of total evinacumab in serum by time at Pre-dose and End of Infusion were analyzed and reported. | The PK analysis set included all randomized participants who received any study drug and for each participant who has at least 1 non-missing post-baseline measurement of evinacumab concentration. Here, "number analyzed" signifies to participants evaluable for this outcome at given timepoints. Data was planned to be reported only for evinacumab arm. | Posted | | Mean | Standard Deviation | milligrams per liter (mg/L) | | Pre-dose and End of Infusion (EOI) at Weeks 0, 4, 8, 12, 16, 20, 24, 32, 36, 40, 44, and 48; Pre-dose at Weeks 28 and 52 | | | | ID | Title | Description |
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| OG000 | Evinacumab | Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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| Secondary | Concentration of Total Angiopoietin-like 3 (ANGPTL3) in Serum | Concentration of total ANGPTL3 in serum by time were analyzed and reported. | The total target analysis set included all treated participants who received any study drug and who had at least 1 non-missing post-dose total ANGPTL3 measurement following the first dose of study drug. Here, "number analyzed" signifies to participants evaluable for this outcome at given timepoints. | Posted | | Mean | Standard Deviation | mg/L | | Pre-dose and End of Infusion (EOI) at Weeks 0, 4, 8, 12, 16, 20, 24, 32, 36, 40, 44, and 48; Pre-dose at Weeks 28 and 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matched-placebo IV infusion Q4W starting from Day 1 up to 52 weeks. | | OG001 | Evinacumab | Participants received evinacumab 20 mg/kg IV infusion Q4W starting from Day 1 up to 52 weeks. |
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