A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (SHTG): The ENTRUST Study

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05852431Tipo: INTERVENTIONALInicio: 15 de jun de 2023Fin estimado: 1 de abr de 2026

Traducción no disponible, mostrando original

Resumen

To determine the effect of Pegozafermin on fasting serum triglyceride levels in subjects with Severe Hypertriglyceridemia (TG ≥500 to ≤2000 mg/dL) after 26 weeks of treatment.

Elegibilidad

Edad mínima: 22 YearsSexo: ALL

Criterios de inclusión

Age ≥22 years
Willing to enter a medication/lifestyle stabilization period during the screening period, which means maintaining those stable medication, eating, and exercise habits for the duration of the study
Subjects should be on stable background Lipid Modifying Therapy (LMT) to manage ASCVD for a minimum of 4 weeks prior to first qualifying TG

Criterios de exclusión

Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Uncontrolled or newly diagnosed (≤3 months since diagnosis) Type 2 diabetes mellitus as determined by the Principal Investigator. Subjects must have HbA1c level ≤9.5% at Screening. Medications for glucose management must be stable for at least 4 weeks prior to Screening
Type 1 diabetes mellitus
A history of symptomatic gallstone disease, gallstone pancreatitis (unless treated with cholecystectomy), or any other ongoing symptomatic biliary disease
Acute pancreatitis within 6 months prior to Screening
Subjects with chronic pancreatitis
Known or suspected familial chylomicronemia syndrome (FCS) (Type 1 hyperlipoproteinemia)

Intervenciones

drug

Pegozafermin

Subcutaneous injection

drug

Placebo

Subcutaneous injection

Ubicaciones

89bio Clinical Study Site

Rosario, Santa Fe Province, Argentina

89bio Clinical Study Site

Buenos Aires, Argentina

89bio Clinical Study Site

Buenos Aires, Argentina

89bio Clinical Study Site

Buenos Aires, Argentina

89bio Clinical Study Site

Córdoba, Argentina

89bio Clinical Study Site

Córdoba, Argentina

89bio Clinical Study Site

Córdoba, Argentina

89bio Clinical Study Site

Córdoba, Argentina

89bio Clinical Study Site

Córdoba, Argentina

89bio Clinical Study Site

Mendoza, Argentina

89bio Clinical Study Site

Rosario, Argentina

89bio Clinical Study Site

San Miguel de Tucumán, Argentina

89bio Clinical Study Site

Viedma, Argentina

Patrocinadores

Principal89bio, Inc.

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