Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
NCT ID: NCT03452228
Last Updated: 2023-02-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2018-06-07
2020-07-23
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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evinacumab
evinacumab
Administered by Intravenous (IV)
Placebo
Placebo
Administered by Intravenous (IV)
Interventions
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evinacumab
Administered by Intravenous (IV)
Placebo
Administered by Intravenous (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of a hospitalization and diagnosis of acute pancreatitis in the past 10 years
3. On stable lipid-modifying diet with or without medications (eg, statins, niacin, omega-3 fatty acids). Lipid-modifying diet and doses of medications should be stable for at least 4 weeks (6 weeks for fibrates, 8 weeks for PCSK9 inhibitors) prior to screening
4. Body mass index (BMI) of 18-40 kg/m2
Exclusion Criteria
2. Lipid apheresis or plasma exchange treatment within the last 4 weeks or plans to undergo apheresis or plasma exchange during the time frame of the study
3. History of class 3/4 heart failure at any time in the past, or hospitalization for heart failure, diagnosis of a myocardial infarction, stroke, Transient ischemic attack (TIA), unstable angina, Coronary artery bypass surgery (CABG), Percutaneous coronary intervention (PCI), carotid surgery/stenting within 3 months before the screening visit
4. History of bleeding disorders, esophageal varices, heparin induced thrombocytopenia, or contraindications to receiving heparin (eg, allergic reaction to heparin)
5. Previous treatment with Glybera® in the past 5 years or treatment with lomitapide or mipomersen in the past 6 months
6. Pregnant or breast feeding women
18 Years
75 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Research Facility
Boca Raton, Florida, United States
Regeneron Research Facility
Atlanta, Georgia, United States
Regeneron Research Facility
Kansas City, Kansas, United States
Regeneron Research Facility
New York, New York, United States
Regeneron Research Facility
Philadelphia, Pennsylvania, United States
Regeneron Research Facility
Pittsburgh, Pennsylvania, United States
Regeneron Research Facility
Dallas, Texas, United States
Regeneron Research Facility
Houston, Texas, United States
Regeneron Research Facility
Milwaukee, Wisconsin, United States
Regeneron Research Facility
Chicoutimi, Quebec, Canada
Regeneron Research Facility
Québec, Quebec, Canada
Regeneron Research Facility
Napoli, Campania, Italy
Regeneron Research Facility
Rome, , Italy
Regeneron Research Facility
Birmingham, , United Kingdom
Regeneron Research Facility
London, , United Kingdom
Regeneron Research Facility
London, , United Kingdom
Regeneron Research Facility
Manchester, , United Kingdom
Countries
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References
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Rosenson RS, Gaudet D, Ballantyne CM, Baum SJ, Bergeron J, Kershaw EE, Moriarty PM, Rubba P, Whitcomb DC, Banerjee P, Gewitz A, Gonzaga-Jauregui C, McGinniss J, Ponda MP, Pordy R, Zhao J, Rader DJ. Evinacumab in severe hypertriglyceridemia with or without lipoprotein lipase pathway mutations: a phase 2 randomized trial. Nat Med. 2023 Mar;29(3):729-737. doi: 10.1038/s41591-023-02222-w. Epub 2023 Mar 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003307-62
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R1500-HTG-1522
Identifier Type: -
Identifier Source: org_study_id
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