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Business decision, unrelated to safety concerns.
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Participants with documented homozygous familial hypercholesterolemia (HoFH) who have provided informed consent will receive 2 open-label doses of ARO-ANG3 and be evaluated for safety and efficacy parameters through 36 weeks. Participants who complete the first 36 week treatment period may opt to continue in an additional 24-month extension period during which they will receive up to 8 doses open-label doses of ARO-ANG3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARO-ANG3 Dose 1 | Experimental | ARO-ANG3 Dose Level 1 subcutaneous (SC) |
|
| ARO-ANG3 Dose 2 | Experimental | ARO-ANG3 Dose Level 2 SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARO-ANG 3 Injection | Drug | Participants will be randomized to receive ARO-ANG3 SC on Day 1 and Day 84 during the initial 36 Weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Fasting LDL-C at Week 24 | LDL-C, computed using Friedewald formula, Martin-Hopkins methodology and preparative ultracentrifugation (PUC). | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Fasting LDL-C (PUC) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 | |
| Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Note: additional inclusion/exclusion criteria may apply per protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 4 | Mount Sinai | New York | 10029 | United States | ||
| Research Site 5 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41422812 | Derived | Raal FJ, Bergeron J, Gaudet D, Rosenson RS, Sullivan DR, Turner T, Hegele RA, Ballantyne CM, Knowles JW, Leeper NJ, Goldberg IJ, Zhou R, Muhsin M, Hellawell J, Hamilton J, Watts GF. Zodasiran, an RNAi therapeutic targeting ANGPTL3, for treating patients with homozygous familial hypercholesterolaemia (GATEWAY): an open-label, randomised, phase 2 trial. Lancet Diabetes Endocrinol. 2026 Feb;14(2):123-136. doi: 10.1016/S2213-8587(25)00290-6. Epub 2025 Dec 18. | |
| 38682459 |
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In this open-label clinical study, participants were randomized in a 1:1 ratio into ARO-ANG3 200 mg or 300 mg dose groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg | Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension (EXT) period. |
| FG001 | ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg | Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 36-Week Treatment Period |
| |||||||||||||
| 24-Month Extension Treatment Period |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg | Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period. |
| BG001 | ARO-ANG3 300 mg / EXT ARO-ANG3 300 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 | Percent Change From Baseline in Fasting LDL-C at Week 24 | LDL-C, computed using Friedewald formula, Martin-Hopkins methodology and preparative ultracentrifugation (PUC). | Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP) | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 24 |
|
Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
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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 | ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg | Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Operating Officer | Arrowhead Pharmaceuticals, Inc. | 1 (626) 304-3400 | info@arrowheadpharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 19, 2025 | Mar 17, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2023 | Mar 17, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000090542 | Homozygous Familial Hypercholesterolemia |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
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| Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Absolute Change From Baseline in Fasting ANGPTL3 Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Absolute Change From Baseline in Fasting Total ApoB Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Absolute Change From Baseline in Fasting HDL-C Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Percent Change From Baseline in Fasting Non-HDL-C Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Absolute Change From Baseline in Fasting Non-HDL-C Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Absolute Change From Baseline in Fasting VLDL-C Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Absolute Change From Baseline in Fasting TC Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Percent Change From Baseline in Fasting Triglycerides (TG) Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Absolute Change From Baseline in Fasting TG Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE occurring during any study phase that: results in death; is immediately life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medically important event or reaction that may require medical intervention to prevent one of the outcomes listed above. AEs are considered treatment-related if the relationship to the study drug is 'possibly related', 'probably related'. A TEAE is defined as an AE that occurs following IP administration or a pre-existing condition exacerbated following IP administration. Injection site reactions are assessed at every visit starting on Day 1 and include any Preferred Term containing 'Injection Site'. | From first dose of study drug up to Week 36 (initial treatment period), and up to Month 24 (extension period) |
| Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time | Baseline, Day 1, Weeks 4, 12, 16, 24 (initial treatment period), Week 36/Day 1, Months 1, 3, 6, 9, 12, 15, 18, 21 (extension period) |
| Percentage of Participants Meeting United States National Lipid Association Apheresis Eligibility Criteria of LDL-C ≥ 300 mg/dL at Week 24 | Apheresis is the extracorporeal process of removing one or more blood constituents from whole blood and returning the remainder to the circulation.The National Lipid Association outlines eligibility criteria for apheresis, particularly for patients with familial hypercholesterolemia who have not achieved target LDL cholesterol levels despite maximally tolerated pharmacotherapy. LDL-C ≥ 300 mg/dL is a criterion. | Week 24 |
| Percentage of Participants Meeting European Union (EU) Apheresis Eligibility Criteria Per German Apheresis Working Group at Week 24 | Apheresis is the extracorporeal process of removing one or more blood constituents from whole blood and returning the remainder to the circulation. The European Union (EU) apheresis eligibility criteria (per German Apheresis Working Group) include the following categories:
| Week 24 |
| Cincinnati |
| Ohio |
| 45227 |
| United States |
| Research Site 8 | Camperdown | New South Wales | 2050 | Australia |
| Research Site 3 | Nedlands | Western Australia | 6009 | Australia |
| Research Site 2 | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Research Site 1 | Québec | Quebec | G1V 4W2 | Canada |
| Research Site 7 | Johannesburg | 2193 | South Africa |
| Derived |
| Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29. |
| NOT COMPLETED |
|
|
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Low Density Lipoprotein Cholesterol (LDL-C) | LDL-C, computed using Friedewald formula, Martin-Hopkins methodology and preparative ultracentrifugation (PUC). | Mean | Standard Deviation | (mg/dL |
|
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|
| Secondary | Percent Change From Baseline in Fasting LDL-C (PUC) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | percentage change | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | percentage change | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | percentage change | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | percentage change | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Absolute Change From Baseline in Fasting ANGPTL3 Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | percentage change | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Absolute Change From Baseline in Fasting Total ApoB Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | percentage change | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Absolute Change From Baseline in Fasting HDL-C Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Percent Change From Baseline in Fasting Non-HDL-C Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | percentage change | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Absolute Change From Baseline in Fasting Non-HDL-C Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | percentage change | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Absolute Change From Baseline in Fasting VLDL-C Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | percentage change | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Absolute Change From Baseline in Fasting TC Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Percent Change From Baseline in Fasting Triglycerides (TG) Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | percentage change | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Absolute Change From Baseline in Fasting TG Over Time | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21 |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE occurring during any study phase that: results in death; is immediately life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medically important event or reaction that may require medical intervention to prevent one of the outcomes listed above. AEs are considered treatment-related if the relationship to the study drug is 'possibly related', 'probably related'. A TEAE is defined as an AE that occurs following IP administration or a pre-existing condition exacerbated following IP administration. Injection site reactions are assessed at every visit starting on Day 1 and include any Preferred Term containing 'Injection Site'. | Safety Analysis Set: All participants who received at least 1 dose of IP. | Posted | Count of Participants | Participants | No | From first dose of study drug up to Week 36 (initial treatment period), and up to Month 24 (extension period) |
|
|
|
| Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time | Safety Analysis Set: All participants who received at least 1 dose of IP. Participants with an assessment at given time point. | Posted | Count of Participants | Participants | No | Baseline, Day 1, Weeks 4, 12, 16, 24 (initial treatment period), Week 36/Day 1, Months 1, 3, 6, 9, 12, 15, 18, 21 (extension period) |
|
|
|
| Secondary | Percentage of Participants Meeting United States National Lipid Association Apheresis Eligibility Criteria of LDL-C ≥ 300 mg/dL at Week 24 | Apheresis is the extracorporeal process of removing one or more blood constituents from whole blood and returning the remainder to the circulation.The National Lipid Association outlines eligibility criteria for apheresis, particularly for patients with familial hypercholesterolemia who have not achieved target LDL cholesterol levels despite maximally tolerated pharmacotherapy. LDL-C ≥ 300 mg/dL is a criterion. | Full Analysis Set: All randomized participants who receive at least 1 dose of IP. | Posted | Number | percentage of participants | Week 24 |
|
|
|
| Secondary | Percentage of Participants Meeting European Union (EU) Apheresis Eligibility Criteria Per German Apheresis Working Group at Week 24 | Apheresis is the extracorporeal process of removing one or more blood constituents from whole blood and returning the remainder to the circulation. The European Union (EU) apheresis eligibility criteria (per German Apheresis Working Group) include the following categories:
| Full Analysis Set: All randomized participants who receive at least 1 dose of IP. | Posted | Number | percentage of participants | Week 24 |
|
|
|
| 0 |
| 9 |
| 2 |
| 9 |
| 7 |
| 9 |
| EG001 | ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg | Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period. | 0 | 9 | 1 | 9 | 7 | 9 |
| Coronary artery disease | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 27.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Tongue geographic | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Vertebral artery stenosis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Renal artery arteriosclerosis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
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| Renal artery stenosis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
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| Renal atrophy | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
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| Brachiocephalic vein stenosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
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| Iliac artery stenosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
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| Jugular vein distension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Study drug-related TEAEs |
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| TEAEs leading to study drug discontinuation |
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| Study drug-related TEAEs leading to discontinuation of study drug |
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| Injection site reaction |
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| Maximum severity of TEAE = Mild |
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| Maximum severity of TEAE = Moderate |
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| Maximum severity of TEAE = Severe |
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| Negative |
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| Week 4 |
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