Condition: Severe Hypertriglyceridemia · Sponsor: Arrowhead Pharmaceuticals
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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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Research Site 1 | Birmingham, Alabama, United States | — |
| Research Site 2 | Mobile, Alabama, United States | — |
| Research Site 3 | Beverly Hills, California, United States | — |
| Research Site 4 | Canoga Park, California, United States | — |
| Research Site 5 | Huntington Beach, California, United States | — |
| Research Site 6 | Lincoln, California, United States | — |
| Research Site 7 | Long Beach, California, United States | — |
| Research Site 8 | Oxnard, California, United States | — |
| Research Site 9 | Clearwater, Florida, United States | — |
| Research Site 10 | North Miami, Florida, United States | — |
| Research Site 11 | Sarasota, Florida, United States | — |
| Research Site 12 | Lawrenceville, Georgia, United States | — |
+ 137 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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