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



Status:Recruiting
Conditions:Gastrointestinal, Metabolic
Therapuetic Areas:Gastroenterology, Pharmacology / Toxicology
Healthy:No
Age Range:18 - 75
Updated:1/17/2019
Start Date:June 7, 2018
End Date:January 22, 2021
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com
Phone:844-734-6643

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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

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


Key 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
12
sites
New York, New York 10065
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Atlanta, Georgia 30328
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Atlanta, GA
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Aurora, Colorado 80045
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Aurora, CO
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Boca Raton, Florida 33434
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Boca Raton, FL
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Chicoutimi, Quebec
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Chicoutimi,
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Dallas, Texas 75390
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Dallas, TX
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Houston, Texas 77030
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Houston, TX
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Kansas City, Kansas 66160
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Kansas City, KS
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Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Minneapolis, Minnesota 55422
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Minneapolis, MN
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15261
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Pittsburgh, PA
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