Calendario›REGN›evinacumab

evinacumab

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

Ensayo de REGENERON PHARMACEUTICALS, INC. en Hipertrigliceridemia.

Más ensayos de: Hipertrigliceridemia.

Fase

Fase 2

Estado

Interrumpido

Participantes

21

previstos

Centros

39

Fin del objetivo primario

feb 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jul 2021.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor Decision».

Qué mide

Percentage of Participants With at Least One Positively Adjudicated Acute Pancreatitis (AP) Episode (del registro, en inglés) (del inicio a las 52 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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 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)

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04863014), actualizada en may 2024.