Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Severe HypertriglyceridemiaThis 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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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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
Study Location
Recherche Clinique Sigma Inc
Recherche Clinique Sigma IncQuébec, Quebec
Canada
Contact Study Team
Centre de Recherche Clinique de Laval
Centre de Recherche Clinique de LavalLaval, Quebec
Canada
Contact Study Team
Medical Arts Health Research Group
Medical Arts Health Research GroupNorth Vancouver, British Columbia
Canada
Contact Study Team
Centre de Medecine Metabolique de Lanaudiere
Centre de Medecine Metabolique de LanaudiereTerrebonne, Quebec
Canada
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Ecogene-21
Ecogene-21Chicoutimi, Quebec
Canada
Contact Study Team
- Study Sponsored By
- Arrowhead Pharmaceuticals
- Participants Required
- More Information
- Study ID:
NCT06347016