Status:
COMPLETED
Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Severe Hypertriglyceridemia (sHTG)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective is to determine the change in Triglyceride (TG) levels following 12 weeks of repeated Intravenous (IV) doses of evinacumab.
Eligibility Criteria
Inclusion
- Key
- Previous documentation in the patient's medical records of a fasting serum TG measurement ≥ 1000 mg/dL (11.3 mmol/L) on more than 1 occasion, and all fasting TG values ≥500 mg/dL (5.6 mmol/L) at screening
- History of a hospitalization and diagnosis of acute pancreatitis in the past 10 years
- 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
- Body mass index (BMI) of 18-40 kg/m2
- Key
Exclusion
- A hospital or clinic discharge diagnosis of acute pancreatitis within 12 weeks of screening
- 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
- 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
- History of bleeding disorders, esophageal varices, heparin induced thrombocytopenia, or contraindications to receiving heparin (eg, allergic reaction to heparin)
- Previous treatment with Glybera® in the past 5 years or treatment with lomitapide or mipomersen in the past 6 months
- Pregnant or breast feeding women
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
June 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03452228
Start Date
June 7 2018
End Date
July 23 2020
Last Update
February 16 2023
Active Locations (17)
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1
Regeneron Research Facility
Boca Raton, Florida, United States, 33434
2
Regeneron Research Facility
Atlanta, Georgia, United States, 30328
3
Regeneron Research Facility
Kansas City, Kansas, United States, 66160
4
Regeneron Research Facility
New York, New York, United States, 10029