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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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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation Criteria

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

Study Location

Medical Arts Health Research Group
Medical Arts Health Research Group
North Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Vaidehi Shah

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

Contact Study Team

Primary Contact

Tabbatha Temlin

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

Contact Study Team

Primary Contact

Tammy Cadieux

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

Contact Study Team

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

Contact Study Team

Primary Contact

Julie Sills

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

Contact Study Team

Primary Contact

Kelly Curtis

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

Contact Study Team

Primary Contact

Sindy Desgagnes

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

Contact Study Team

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

Contact Study Team

Primary Contact

Sylvie Gauthier

[email protected]
450 688-4340
Institut De Recherche Clinique De Montreal
Institut De Recherche Clinique De Montreal
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Nathalie Saint-Pierre

[email protected]
514 987-5653
Study Sponsored By
Arrowhead Pharmaceuticals
Participants Required
More Information
Study ID: NCT06347133