Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
HypertriglyceridemiaThis Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). 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.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
Inclusion Criteria:
* Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L)
* Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 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%
* Willing to follow diet counseling and maintain a stable low-fat diet
* 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
* Acute pancreatitis within 4 weeks prior to screening
* Body mass index \>45 kg/m\^2
Note: Additional Inclusion/Exclusion criteria may apply per protocol
Lieu de l'étude
Medical Arts Health Research Group
Medical Arts Health Research GroupNorth Vancouver, British Columbia
Canada
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Clinical Research Solutions Inc.
Clinical Research Solutions Inc.Waterloo, Ontario
Canada
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Centre de Medicine Metabolique de Lanaudiere
Centre de Medicine Metabolique de LanaudiereQuébec, Quebec
Canada
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Bluewater Clinical Research Group Inc.
Bluewater Clinical Research Group Inc.Sarnia, Ontario
Canada
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Clinique des Maladies Lipidiques de Quebec
Clinique des Maladies Lipidiques de QuebecQuébec, Quebec
Canada
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Discovery Clinical Services Ltd.
Discovery Clinical Services Ltd.Victoria, British Columbia
Canada
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Ecogene-21
Ecogene-21Chicoutimi, Quebec
Canada
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Centricity Research Brampton
Centricity Research BramptonBrampton, Ontario
Canada
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Centre de Recherche Clinique de Laval
Centre de Recherche Clinique de LavalLaval, Quebec
Canada
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Institut De Recherche Clinique De Montreal
Institut De Recherche Clinique De MontrealMontréal, Quebec
Canada
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- Étude parrainée par
- Arrowhead Pharmaceuticals
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06347133