Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

Description

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.

Conditions

Severe Hypertriglyceridemia

Study Overview

Study Details

Study overview

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.

Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia

Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

Condition
Severe Hypertriglyceridemia
Intervention / Treatment

-

Contacts and Locations

Garden Grove

National Institute of Clinical Research, Garden Grove, California, United States, 92844

Lake Forest

Orange County Research Center, Lake Forest, California, United States, 92630

Montclair

Catalina Research Institute, Montclair, California, United States, 91763

Panorama City

Velocity Clinical Research, Panorama City, Panorama City, California, United States, 91402

Redding

The Cardiovascular Center, Redding, California, United States, 96001

Colorado Springs

Legacy Clinical Trials, Colorado Springs, Colorado, United States, 80909

Hialeah

Neoclinical Research, Hialeah, Florida, United States, 33016

Lake City

East Coast Institute for Research, LLC, Lake City, Florida, United States, 32055

Miami Lakes

Panax Clinical Research, Miami Lakes, Florida, United States, 33014

Mount Dora

Adult Medicine of Lake County, Mount Dora, Florida, United States, 32757

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/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%
  • * 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)
  • * 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
  • * 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
  • * Acute pancreatitis within 4 weeks prior to screening
  • * Body mass index \>45kg/m\^2

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arrowhead Pharmaceuticals,

Study Record Dates

2026-10