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This is a Phase 1, randomized, parallel-cohort, open-label study to characterize the pharmacokinetics, pharmacodynamics, safety and tolerability of vupanorsen following 80 mg and 160 mg single subcutaneous dose in healthy Chinese adults with elevated fasting triglyceride.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vupanorsen 80 milligram (mg) | Experimental | Participants will receive one, 0.8 milliliter (mL) subcutaneous injection with vupanorsen 100 mg/mL solution |
|
| Vupanorsen 160 milligram (mg) | Experimental | Participants will receive two, 0.8 mL subcutaneous injections with vupanorsen 100 mg/mL solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vupanorsen | Drug | 80 mg subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC24h) for Vupanorsen | AUC24h is the area under the concentration-time profile from time 0 to 24 hour post-dose | 0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on day 1 |
| AUC From Time 0 to 48 Hours Post-dose (AUC48h) for Vupanorsen | AUC48h is the area under the plasma concentration-time profile from time zero to the quantifiable concentration 48 hours post-dose | 0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose |
| AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Vupanorsen | AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
| Maximum Observed Concentration (Cmax) | Maximum plasma concentration observed from data | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
| AUC From Time 0 Extrapolated to Infinite Time (AUCinf) for Vupanorsen | AUCinf is area under the plasma concentration-time profile from time zero extrapolated to infinite time | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
| Time for Cmax (Tmax) for Vupanorsen | Time for Cmax (Tmax) for vupanorsen |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Causality to study treatment was determined by the investigator. |
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Inclusion Criteria:
Male and female Chinese participants must be 18 to 65 years of age, inclusive, at the time of signing the ICD.
Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests (except for TG levels), and 12-lead ECG monitoring.
Fasting TG ≥ 90 mg/dL at Screening (up to 1 repeat allowed for TG and the second TG value will be used for the eligibility).
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
BMI of 17.5 to 35.0 kg/m2; and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
History of human immunodeficiency virus (HIV) infection, syphilis, hepatitis B, or hepatitis C; positive testing for HIV, syphilis, HBsAg, or HCVAb. Prior Hepatitis B vaccination is allowed.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
Previous administration with an investigational drug within 4 months or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
A positive urine drug test.
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval >450 msec, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
Blood donation (excluding plasma donations) of approximately 400 mL or more within 60 days prior to dosing.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
History of substance abuse within 12 months of the screening visit.
Pregnant females; breastfeeding females.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital,Fudan University | Shanghai | Shanghai Municipality | 201107 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38949758 | Derived | Wu X, Yu J, Ge B, Wang J, Han X, Zhang C, Mao X, Kalluru H, Bramson C, Terra SG, Liu J. A Randomized, Open-Label, Phase I, Single-Dose Study of Antisense Oligonucleotide, Vupanorsen, in Chinese Adults with Elevated Triglycerides. Drugs R D. 2024 Jun;24(2):253-262. doi: 10.1007/s40268-024-00467-5. Epub 2024 Jul 1. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vupanorsen 80 mg | Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90. |
| FG001 | Vupanorsen 160 mg | Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population included all participants enrolled and who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vupanorsen 80 mg | Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90. |
| BG001 | Vupanorsen 160 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC24h) for Vupanorsen | AUC24h is the area under the concentration-time profile from time 0 to 24 hour post-dose | The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen pharmacokinetic (PK) parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per milliliter(mcg*hr/mL) | 0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on day 1 |
|
Baseline through day 90
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vupanorsen 80 mg | Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 28, 2020 | Sep 2, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2020 | Sep 2, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000723171 | vupanorsen |
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| Vupanorsen |
| Drug |
80 mg subcutaneous injection |
|
| 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
| Terminal Elimination Half Life (t½) for Vupanorsen | terminal elimination half life (t½) for vupanorsen | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
| Apparent Clearance (CL/F) for Vupanorsen | Apparent clearance for vupanorsen | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
| Apparent Volume of Distribution (Vz/F) for Vupanorsen | Apparent volume of distribution for vupanorsen | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
| Baseline through day 90 |
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria. | Baseline through day 90 |
| Number of Participants With Clinically Significant Vital Sign Values | Vital sign data included blood pressure and pulse rate. Clinical significance was assessed by the investigator. | Baseline through day 90 |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | Clinical significance of ECG data was assessed by the investigator. | Baseline through day 90 |
| Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | Percent changes from baseline in ANGPTL3 on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Total Cholesterol | Percentage changes from baseline in total cholesterol on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | Percentage changes from baseline in HDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Percentage changes from baseline in LDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | Percentage changes from baseline in VLDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Triglyceride | Percentage changes from baseline in triglyceride on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Percentage changes from baseline in non-HDL on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
| Percent Change From Baseline in Apolipoprotein A-1 (ApoA-I) | Percentage changes from baseline in ApoA-I on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan. | Day 1, Day 15, Day 60, and Day 90 |
| Percent Change From Baseline in Apolipoprotein B (ApoB) Total (Including ApoB-48, ApoB-100) | Percentage changes from baseline in ApoB total (including ApoB-48, ApoB-100) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan. | Day 1, Day 15, Day 60, and Day 90 |
| Percent Change From Baseline in Apolipoprotein C-III (ApoC-III) | Percentage changes from baseline in apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan. | Day 1, Day 15, Day 60, and Day 90 |
Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Vupanorsen 160 mg |
Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90. |
|
|
| Primary | AUC From Time 0 to 48 Hours Post-dose (AUC48h) for Vupanorsen | AUC48h is the area under the plasma concentration-time profile from time zero to the quantifiable concentration 48 hours post-dose | The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | 0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose |
|
|
|
| Primary | AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Vupanorsen | AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) | The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
|
|
|
| Primary | Maximum Observed Concentration (Cmax) | Maximum plasma concentration observed from data | The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
|
|
|
| Primary | AUC From Time 0 Extrapolated to Infinite Time (AUCinf) for Vupanorsen | AUCinf is area under the plasma concentration-time profile from time zero extrapolated to infinite time | The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
|
|
|
| Primary | Time for Cmax (Tmax) for Vupanorsen | Time for Cmax (Tmax) for vupanorsen | The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest. | Posted | Median | Full Range | hour (hr) | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
|
|
|
| Primary | Terminal Elimination Half Life (t½) for Vupanorsen | terminal elimination half life (t½) for vupanorsen | The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest. | Posted | Mean | Standard Deviation | hour (hr) | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
|
|
|
| Primary | Apparent Clearance (CL/F) for Vupanorsen | Apparent clearance for vupanorsen | The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/hr) | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
|
|
|
| Primary | Apparent Volume of Distribution (Vz/F) for Vupanorsen | Apparent volume of distribution for vupanorsen | The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter (L) | 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90 |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Causality to study treatment was determined by the investigator. | All participants enrolled and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline through day 90 |
|
|
|
| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria. | All participants enrolled and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline through day 90 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Vital Sign Values | Vital sign data included blood pressure and pulse rate. Clinical significance was assessed by the investigator. | All participants enrolled and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline through day 90 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | Clinical significance of ECG data was assessed by the investigator. | All participants enrolled and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline through day 90 |
|
|
|
| Secondary | Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3) | Percent changes from baseline in ANGPTL3 on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | All participants enrolled and treated who had at least 1 of the pharmacodynamic (PD) parameters of interest. | Posted | Mean | Standard Deviation | percent change (%) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
|
|
|
| Secondary | Percent Change From Baseline in Total Cholesterol | Percentage changes from baseline in total cholesterol on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | All participants enrolled and treated who had at least 1 of the PD parameters of interest. | Posted | Mean | Standard Deviation | percent change (%) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
|
|
|
| Secondary | Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | Percentage changes from baseline in HDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | All participants enrolled and treated who had at least 1 of the PD parameters of interest. | Posted | Mean | Standard Deviation | percent change (%) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
|
|
|
| Secondary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Percentage changes from baseline in LDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | All participants enrolled and treated who had at least 1 of the PD parameters of interest. | Posted | Mean | Standard Deviation | percent change (%) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
|
|
|
| Secondary | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) | Percentage changes from baseline in VLDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | All participants enrolled and treated who had at least 1 of the PD parameters of interest. | Posted | Mean | Standard Deviation | percent change (%) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
|
|
|
| Secondary | Percent Change From Baseline in Triglyceride | Percentage changes from baseline in triglyceride on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | All participants enrolled and treated who had at least 1 of the PD parameters of interest. | Posted | Mean | Standard Deviation | percent change (%) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
|
|
|
| Secondary | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Percentage changes from baseline in non-HDL on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 | All participants enrolled and treated who had at least 1 of the PD parameters of interest. | Posted | Mean | Standard Deviation | percent change (%) | Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90 |
|
|
|
| Secondary | Percent Change From Baseline in Apolipoprotein A-1 (ApoA-I) | Percentage changes from baseline in ApoA-I on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan. | Study endpoint of percent changes from baseline in apolipoprotein A-1 (ApoA-I),apolipoprotein B (ApoB) total (including ApoB-48, ApoB-100), and apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90, were terminated due to changes of development plan. No data were collected for these terminated endpoints. | Posted | Day 1, Day 15, Day 60, and Day 90 |
|
|
| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) Total (Including ApoB-48, ApoB-100) | Percentage changes from baseline in ApoB total (including ApoB-48, ApoB-100) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan. | Study endpoint of percent changes from baseline in apolipoprotein A-1 (ApoA-I),apolipoprotein B (ApoB) total (including ApoB-48, ApoB-100), and apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90, were terminated due to changes of development plan. No data were collected for these terminated endpoints. | Posted | Day 1, Day 15, Day 60, and Day 90 |
|
|
| Secondary | Percent Change From Baseline in Apolipoprotein C-III (ApoC-III) | Percentage changes from baseline in apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan. | Study endpoint of percent changes from baseline in apolipoprotein A-1 (ApoA-I),apolipoprotein B (ApoB) total (including ApoB-48, ApoB-100), and apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90, were terminated due to changes of development plan. No data were collected for these terminated endpoints. | Posted | Day 1, Day 15, Day 60, and Day 90 |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | Vupanorsen 160 mg | Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90. | 0 | 9 | 0 | 9 | 5 | 9 |
| Ventricular extrasystoles | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Mesenteric panniculitis | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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