A Phase 2 study to evaluate safety and efficacy of Evinacumab in patients with severe hypertriglyceridemia at risk for acute pancreatitis.

Phase 1

Active, not recruiting

• Conditions: Severe Hypertriglyceridemia (sHTG); MedDRA version: 20.1Level: LLTClassification code 10020870Term: HypertriglyceridemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-003307-62-GB
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-23
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Males and females =18 to 75 years of age at screening
2. 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
3. History of a hospitalization and diagnosis of acute pancreatitis in the past 10 years.
4. On a 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
5. BMI index of 18-40 kg/m2
6. Provide signed informed consent
7. Willing and able to comply with clinic visits and study-related procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, TIA, unstable angina, CABG, 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. New clinically significant findings on 12-lead electrocardiogram (ECG) that would place the patient at risk or interfere with participation in the study
6. Women of childbearing potential (WOCBP)* who are unwilling to practice a highly effective birth control method prior to the initial dose, during the study, and for 24 weeks after the last dose of study drug.
*Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Postmenopausal status will be confirmed by measurement of follicle-stimulating hormone (FSH). Pregnancy testing and contraception are not required for women with documented hysterectomy and/or oophorectomy.
7. Men who are sexually active with WOCBP and are unwilling to consistently use condoms during the study drug treatment period and for 24 weeks after the last administration of study drug, regardless of vasectomy status. Sperm donation is prohibited during the study and for up to 24 weeks after the last administration of study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified