Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2021-06-28
2024-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ARO-ANG3 50 mg
Two doses of ARO-ANG3 by subcutaneous (sc) injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
ARO-ANG3
ARO-ANG3 Injection
ARO-ANG3 100 mg
Two doses of ARO-ANG3 bysc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
ARO-ANG3
ARO-ANG3 Injection
ARO-ANG3 200 mg
Two doses of ARO-ANG3 by sc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
ARO-ANG3
ARO-ANG3 Injection
Placebo
Calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
ARO-ANG3
ARO-ANG3 Injection
Placebo
Sterile Normal Saline (0.9% NaCl)
Interventions
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ARO-ANG3
ARO-ANG3 Injection
Placebo
Sterile Normal Saline (0.9% NaCl)
Eligibility Criteria
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Inclusion Criteria
* Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy
* Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 17 days apart
* Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care
* Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication
* Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
* Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
* Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
* Able and willing to provide written informed consent and to comply with study requirements
Exclusion Criteria
* Active pancreatitis within 12 weeks prior to Day 1
* Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
* Acute coronary syndrome event within 24 weeks of Day 1
* Major surgery within 12 weeks of Day 1 or planned surgery during the study
* Planned coronary intervention (e.g., stent placement or heart bypass) during the study
* Uncontrolled hypertension
* Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
* Uncontrolled hypothyroidism or hyperthyroidism
* Hemorrhagic stroke within 24 weeks of Day 1
* History of bleeding diathesis or coagulopathy
* Current diagnosis of nephrotic syndrome
* Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study
* Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)
18 Years
ALL
No
Sponsors
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Arrowhead Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Research Site 9
Québec, , Canada
Research Site 19
Birkenhead, , New Zealand
Research Site 13
Christchurch, , New Zealand
Research Site 20
Hamilton, , New Zealand
Research Site 14
Rotorua, , New Zealand
Research Site 5
Huntington Park, California, United States
Research Site 7
Hialeah, Florida, United States
Research Site 17
Miami, Florida, United States
Research Site 8
Port Orange, Florida, United States
Research Site 24
Minneapolis, Minnesota, United States
Research Site 10
Omaha, Nebraska, United States
Research Site 23
Las Vegas, Nevada, United States
Research Site 22
New York, New York, United States
Research Site 15
Greensboro, North Carolina, United States
Research Site 2
Morehead City, North Carolina, United States
Research Site 1
Marion, Ohio, United States
Research Site 4
Camp Hill, Pennsylvania, United States
Research Site 11
Houston, Texas, United States
Research Site 6
Blacktown, New South Wales, Australia
Research Site 21
Sippy Downs, Queensland, Australia
Research Site 18
Nedlands, , Australia
Research Site 25
London, Ontario, Canada
Research Site 16
Chicoutimi, Quebec, Canada
Research Site 12
Québec, , Canada
Countries
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References
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Rosenson RS, Gaudet D, Hegele RA, Ballantyne CM, Nicholls SJ, Lucas KJ, San Martin J, Zhou R, Muhsin M, Chang T, Hellawell J, Watts GF; ARCHES-2 Trial Team. Zodasiran, an RNAi Therapeutic Targeting ANGPTL3, for Mixed Hyperlipidemia. N Engl J Med. 2024 Sep 12;391(10):913-925. doi: 10.1056/NEJMoa2404147. Epub 2024 May 29.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AROANG3-2001
Identifier Type: -
Identifier Source: org_study_id
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