Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06347003Tipo: INTERVENTIONALInicio: 22 de jul de 2024Fin estimado: 1 de sept de 2026

Traducción no disponible, mostrando original

Resumen

This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/L)
Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
Fasting low density lipoprotein-cholesterol (LDL-C) ≤130 mg/dL (≤3.37 mmol/L) at screening
Screening HbA1C ≤9.0%
Willing to follow diet counseling and maintain a stable low-fat diet
Must be on standard of care lipid and TG lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due to a previous adverse reaction associated with, attributed to, or caused by specific drug)

Criterios de exclusión

Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks
Use of any other hepatocyte-targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer
Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1-causing genes
Acute pancreatitis within 4 weeks prior to screening
Body mass index \>45kg/m\^2

Intervenciones

drug

Plozasiran Injection

ARO-APOC3 Injection

drug

Placebo

sterile normal saline (0.9% NaCl)

Ubicaciones

Research Center 8

Ramos Mejía, Buenos Aires, Argentina

Research Center 10

San Isidro, Buenos Aires, Argentina

Research Center 7

Temperley, Buenos Aires, Argentina

Research Center 4

Córdoba, Córdoba Province, Argentina

Research Center 9

Córdoba, Córdoba Province, Argentina

Research Center 5

Córdoba, Córdoba Province, Argentina

Research Center 3

Córdoba, Córdoba Province, Argentina

Research Center 6

Buenos Aires, Argentina

Research Center 2

Buenos Aires, Argentina

Research Center 1

Buenos Aires, Argentina

Patrocinadores

PrincipalArrowhead Pharmaceuticals

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