Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Severe Hypertriglyceridemia (HTG), Recurrent Acute Pancreatitis Read More

Key Inclusion Criteria:

1. Adults without FCS due to LPL loss of function mutations
2. Documented history of 1 HTG-associated AP episode within 24 months of screening
3. 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
4. Stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study
5. Body mass index ≥18.0 and ≤45.0 kg/m2
6. Compliance with a stable diet and exercise regimen at screening and willingness to continue the diet through the end of the study

Key Exclusion Criteria:

1. Hospitalization for AP within 4 weeks of screening
2. Known genetic FCS defined as homozygous or compound heterozygous LoF mutations in LPL as defined in the protocol
3. Symptomatic gallstone disease within 6 months prior to screening as defined in the protocol
4. 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
5. Presence of any clinically significant, uncontrolled endocrine disease known to influence serum lipids as defined in the protocol
6. 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