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

• Status: Recruiting
• Trial end date: 2024-10-22
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to determine the proportion of patients with triglycerides (TG) >880 mg/dL, without familial chylomicronemia syndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL), and a history of hypertriglyceridemia (HTG)-associated acute pancreatitis (AP) who experience a recurrent episode of AP after treatment with evinacumab versus placebo.

The secondary objectives of the study are:

• To determine the change in the standard lipid profile after therapy with evinacumab versus placebo

• To determine the changes in specialty lipoprotein parameters (ApoC3, ApoB48, ApoB100, and nuclear magnetic resonance [NMR] lipid profile) after therapy with evinacumab versus placebo

• To measure the number of AP episodes per patient

• To assess the safety and tolerability of evinacumab

• To assess the potential immunogenicity of evinacumab

• To assess the concentrations of total evinacumab and total angiopoietin-like 3 (ANGPTL3)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals

Criteria

Key Inclusion Criteria:

1. Documented history of HTG-associated AP within 15 months of screening

2. Fasting serum TG value >880 mg/dL (10 mmol/L) on 2 occasions at least 2 days apart determined during the screening period.

3. Stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study

4. Body mass index ≥18.0 and ≤40.0 kg/m2

5. 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

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply