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Study of Plozasiran in Adults With Severe Hypertriglyceridemia

Active Not RecruitingPhase 3

Sponsor: Arrowhead Pharmaceuticals

Conditions: Severe Hypertriglyceridemia

Interventions: Plozasiran Injection, Placebo

Countries: United States, Argentina, Brazil, Bulgaria, Canada, Czechia, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥500 mg/dL (≥5.65 mmol/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 ≤9.0%
* Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due to a previous adverse reaction associated with, attributed to, or caused by specific drug)

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 (except inclisiran, which is permitted)
* 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
* Body mass index \>45kg/m\^2

Note: Additional Inclusion/Exclusion criteria may apply per protocol

Locations (149)

Birmingham, Alabama, United States
Mobile, Alabama, United States
Beverly Hills, California, United States
Canoga Park, California, United States
Huntington Beach, California, United States
Lincoln, California, United States
Long Beach, California, United States
Oxnard, California, United States
Clearwater, Florida, United States
North Miami, Florida, United States
Sarasota, Florida, United States
Lawrenceville, Georgia, United States
Sugar Hill, Georgia, United States
Elkhart, Indiana, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
Overland Park, Kansas, United States
Topeka, Kansas, United States
Metairie, Louisiana, United States
Annapolis, Maryland, United States
Jackson, Mississippi, United States
Fremont, Nebraska, United States
Norfolk, Nebraska, United States
Morristown, New Jersey, United States
New York, New York, United States
Riverhead, New York, United States
The Bronx, New York, United States
Asheboro, North Carolina, United States
Wilmington, North Carolina, United States
Beavercreek, Ohio, United States
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