Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
353 participants
INTERVENTIONAL
2021-09-28
2023-08-14
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-APOC3 10 mg, Day 1 and Week 12
2 doses of ARO-APOC3 by subcutaneous (sc) injection
ARO-APOC3
ARO-APOC3 Injection
ARO-APOC3 25 mg, Day 1 and Week 12
2 doses of ARO-APOC3 by subcutaneous (sc) injection
ARO-APOC3
ARO-APOC3 Injection
ARO-APOC3 50 mg, Day 1 and Week 12
2 doses of ARO-APOC3 by subcutaneous (sc) injection
ARO-APOC3
ARO-APOC3 Injection
ARO-APOC3 50 mg, Day 1 and Week 24
2 doses of ARO-APOC3 by subcutaneous (sc) injection
ARO-APOC3
ARO-APOC3 Injection
Placebo, Day 1 and Week 12 or Week 24
calculated volume to match active treatment by sc injection
Placebo
Sterile Normal Saline (0.9% NaCl)
Interventions
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ARO-APOC3
ARO-APOC3 Injection
Placebo
Sterile Normal Saline (0.9% NaCl)
Eligibility Criteria
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Inclusion Criteria
* Fasting levels at Screening of non-HDL-C ≥ 100 mg/dL OR LDL-C ≥ 70 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 14 days apart
* Willing to follow diet counseling as per Investigator judgment based on local standard of care
* Participants of childbearing potential (males \& females) must use highly-effective contraception during the study and for at least 24 weeks following the last dose of study medication. Males must not donate sperm and females must ot donate eggs during the study and for at least 24 weeks following the last dose of study medication.
* Women of childbearing potential must have a negative pregnancy test at Screening 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
* 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 through end of study
* Acute coronary syndrome event within 24 weeks of Day 1
* Major surgery within 12 weeks of Day 1
* Planned coronary intervention (e.g., stent placement or heart bypass) during the study
* New York Heart Association Class II, III or IV heart failure or last known ejection fraction of \<30%
* Uncontrolled hypertension
* Known history of 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 3
Beverly Hills, California, United States
Research Site 8
Northridge, California, United States
Research Site 2
Boca Raton, Florida, United States
Research Site 1
Fort Lauderdale, Florida, United States
Research Site 14
Miami Springs, Florida, United States
Research Site 5
Pembroke Pines, Florida, United States
Research Site 18
Dunwoody, Georgia, United States
Research Site 31
Las Vegas, Nevada, United States
Research Site 17
New Windsor, New York, United States
Research Site 12
Dayton, Ohio, United States
Research Site 4
Franklin, Ohio, United States
Research Site 7
Greenville, South Carolina, United States
Research Site 6
Houston, Texas, United States
Research Site 32
Houston, Texas, United States
Research Site 13
San Antonio, Texas, United States
Research Site 30
Morayfield, Queensland, Australia
Research Site 29
Adelaide, South Australia, Australia
Research Site 19
Clayton, Victoria, Australia
Research Site 27
Joondalup, Western Australia, Australia
Research Site 15
Concord, Ontario, Canada
Research Site 10
Montreal, Quebec, Canada
Research Site 20
Balatonfüred, , Hungary
Research Site 21
Debrecen, , Hungary
Research Site 22
Nyíregyháza, , Hungary
Research Site 11
Auckland, , New Zealand
Research Site 16
Christchurch, , New Zealand
Research Site 28
Lodz, , Poland
Research Site 24
Lodz, , Poland
Research Site 25
Poznan, , Poland
Research Site 26
Rzeszów, , Poland
Countries
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References
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Ballantyne CM, Vasas S, Azizad M, Clifton P, Rosenson RS, Chang T, Melquist S, Zhou R, Mushin M, Leeper NJ, Hellawell J, Gaudet D. Plozasiran, an RNA Interference Agent Targeting APOC3, for Mixed Hyperlipidemia. N Engl J Med. 2024 Sep 12;391(10):899-912. doi: 10.1056/NEJMoa2404143. Epub 2024 May 28.
Other Identifiers
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2021-000688-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AROAPOC3-2002
Identifier Type: -
Identifier Source: org_study_id
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