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Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

A Phase 2, Randomized, Placebo-Controlled Study of Safety and Efficacy, Following Repeat-Dose Administration of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

NCT03452228•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

The primary objective is to determine the change in Triglyceride (TG) levels following 12 weeks of repeated Intravenous (IV) doses of evinacumab.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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
•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

•1. A hospital or clinic discharge diagnosis of acute pancreatitis within 12 weeks of screening
•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

Locations (17)

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

Key Dates

Start Date

June 7, 2018

Primary Completion Date

December 17, 2019

Completion Date

July 23, 2020

Last Updated

February 16, 2023

Enrollment

ACTUAL participants

Conditions

Severe Hypertriglyceridemia (sHTG)

Interventions

evinacumab

DRUG

Placebo

DRUG