Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

Description

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.

Conditions

Hypertriglyceridemia

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Study Overview

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Study Details

Study overview

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.

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

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

Condition
Hypertriglyceridemia
Intervention / Treatment

-

Contacts and Locations

Birmingham

Ascension St. Vincents Birmingham, Birmingham, Alabama, United States, 35205

Mobile

IMC Diagnostic and Medical Clinic, LLC, Mobile, Alabama, United States, 36604

Beverly Hills

National Heart Institute, Beverly Hills, California, United States, 90211

Canoga Park

Hope Clinical Research, Canoga Park, California, United States, 91303

Garden Grove

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

Huntington Beach

National Institute of Clinical Research, Inc., Huntington Beach, California, United States, 92648

Lake Forest

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

Lincoln

Clinical Trials Research, Lincoln, California, United States, 95648

Montclair

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

Oxnard

Fomat Medical Research, Inc., Oxnard, California, United States, 93030

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 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)
  • * 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

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