Status:
TERMINATED
Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to determine the proportion of patients with elevated triglycerides (TG), without familial chylomicronemia syndrome (FCS) due to loss of function (LoF) mutations ...
Eligibility Criteria
Inclusion
- Key
- Adults without FCS due to LPL loss of function mutations
- Documented history of 1 HTG-associated AP episode within 24 months of screening
- Fasting serum TG value \>880 mg/dL (10 mmol/L) or \>500 mg/dL (5.6mmol/L) determined during the screening period as described in the protocol
- Stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study
- Body mass index ≥18.0 and ≤45.0 kg/m2
- Compliance with a stable diet and exercise regimen at screening and willingness to continue the diet through the end of the study
- Key
Exclusion
- Hospitalization for AP within 4 weeks of screening
- Known genetic FCS defined as homozygous or compound heterozygous LoF mutations in LPL as defined in the protocol
- Symptomatic gallstone disease within 6 months prior to screening as defined in the protocol
- Use of any medication or nutraceutical known to alter serum lipids which has not been part of a stable therapeutic regimen for at least 8 weeks, and there are no plans to change the regimen during the study
- Presence of any clinically significant, uncontrolled endocrine disease known to influence serum lipids as defined in the protocol
- Has received a COVID-19 vaccination within 1-week of planned start medication or for which the planned COVID-19 vaccination would not be completed 1-week prior to start of the study
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04863014
Start Date
July 12 2021
End Date
February 15 2023
Last Update
May 22 2024
Active Locations (39)
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1
Radin Cardivascular Medical Group, Inc
Newport Beach, California, United States, 92663
2
Yale Cancer Center - Yale University
New Haven, Connecticut, United States, 06510
3
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States, 33434
4
Harmony Medical Research Institute, Inc.
Hialeah, Florida, United States, 33015