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Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

Hypertriglyceridemia

This 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

  • 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 Group
North Vancouver, British Columbia
Canada

Contactez l'équipe d'étude

Primary Contact

Vaidehi Shah

[email protected]
1 888-736-0667
Clinical Research Solutions Inc.
Clinical Research Solutions Inc.
Waterloo, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Tabbatha Temlin

[email protected]
Centre de Medicine Metabolique de Lanaudiere
Centre de Medicine Metabolique de Lanaudiere
Québec, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Tammy Cadieux

[email protected]
514-907-5101
Bluewater Clinical Research Group Inc.
Bluewater Clinical Research Group Inc.
Sarnia, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Teresa Ferrari Nicefield

[email protected]
(519) 344-6612
Clinique des Maladies Lipidiques de Quebec
Clinique des Maladies Lipidiques de Quebec
Québec, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Julie Sills

[email protected]
418-780-1376
Discovery Clinical Services Ltd.
Discovery Clinical Services Ltd.
Victoria, British Columbia
Canada

Contactez l'équipe d'étude

Primary Contact

Kelly Curtis

[email protected]
1-250-386-0023
Ecogene-21
Ecogene-21
Chicoutimi, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Sindy Desgagnes

[email protected]
418 545-1252
Centricity Research Brampton
Centricity Research Brampton
Brampton, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Neha Neha Ghai

[email protected]
905-595-0560
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
Institut De Recherche Clinique De Montreal
Institut De Recherche Clinique De Montreal
Montréal, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Nathalie Saint-Pierre

[email protected]
514 987-5653
Étude parrainée par
Arrowhead Pharmaceuticals
Participants recherchés
Plus d'informations
ID de l'étude: NCT06347133