NL-OMON52186
Completed
Phase 2
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients with Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis - R1500-HTG-20118 (ICON 0456/0418)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Regeneron Pharmaceuticals, Inc.
- Enrollment
- 8
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •A patient must meet the following criteria to be eligible for inclusion in the
- •1\. Adults 18 to 80 years of age without FCS due to LPL loss of function
- •2\. Documented history of 1 HTG\-associated AP episode within 24 months of
- •screening (can be determined by study investigator; does not need to be
- •confirmed by independent adjudication committee).
- •3\. Fasting serum TG value \>880 mg/dL (10 mmol/L) on 2 occasions at least 2 days
- •apart determined during the screening period. Triglyceride measurement can be
- •repeated once for values \>500 mg/dL (5\.6 mmol/L) but \<880 mg/dL (10 mmol/L)
- •Fasting serum TG value \>500 mg/dL (5\.6 mmol/L) determined during the screening
- •period in patients with a history of 2 or more HTGassociated AP episodes within
Exclusion Criteria
- •A patient who meets any of the following criteria will be excluded from the
- •1\. Hospitalization for AP within 4 weeks of screening
- •2\. Known genetic FCS defined as homozygous or compound heterozygous LoF
- •mutations in LPL, as documented by prior genotype result or determined from FCS
- •genotyping at screening (see Section 9\.2\.7\).
- •3\. Symptomatic gallstone disease within 6 months prior to screening. Incidental
- •and/or asymptomatic gallstones are permitted. Patients with symptomatic
- •gallstone disease in the past 6 months who have undergone cholecystectomy \>3
- •months prior to screening are permitted.
- •4\. Use of any medication or nutraceutical known to alter serum lipids which has
Outcomes
Primary Outcomes
Not specified
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