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Study of Plozasiran in Adults With Severe Hypertriglyceridemia

Severe Hypertriglyceridemia

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.

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

Inclusion Criteria:

* Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥500 mg/dL (≥5.65 mmol/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 ≤8.5%
* Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator)

Exclusion Criteria:

* 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 (except inclisiran, which is permitted)
* 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
* Body mass index \>45kg/m\^2

Note: Additional Inclusion/Exclusion criteria may apply per protocol

Lieu de l'étude

Recherche Clinique Sigma Inc
Recherche Clinique Sigma Inc
Québec, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Marie-Claude Bolvin

[email protected]
(418)-561-1165
Centre de Recherche Clinique de Laval
Centre de Recherche Clinique de Laval
Laval, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Sylvie Gauthier

[email protected]
450 688-4340
Medical Arts Health Research Group
Medical Arts Health Research Group
North Vancouver, British Columbia
Canada

Contactez l'équipe d'étude

Primary Contact

Vaidehi Shah

[email protected]
888-736-0667
Centre de Medecine Metabolique de Lanaudiere
Centre de Medecine Metabolique de Lanaudiere
Terrebonne, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Tammy Cadieux

[email protected]
514-907-5101
Ecogene-21
Ecogene-21
Chicoutimi, Quebec
Canada

Contactez l'équipe d'étude

Étude parrainée par
Arrowhead Pharmaceuticals
Participants recherchés
Plus d'informations
ID de l'étude: NCT06347016