Testing Plozasiran for hypertriglyceridemia

Inclusion

• +Subjects in the USA and Canada who completed protocolProtocolThe detailed plan a study must follow.Read more → AROAPOC3-2003 meeting all eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → (with the exception of inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → #9 which is not applicable to these subjects) who also meet the following additional criteria may enroll in this trial:
• +Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND either (c) or (d) below:
• +BaselineBaselineYour starting measurements, taken before treatment begins.Read more → fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → into AROAPOC3-2001
• +Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001
• +Subjects who previously met all eligibility requirements for AROAPOC3-3003, or AROAPOC3-3004 and were not permitted to proceed to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → per SponsorSponsorThe organisation responsible for the study overall.Read more →'s direction in order to prevent excessive over-enrollment may also be enrolled in this trial. These subjects must meet all eligibility criteria prior to enrollment (with the exception of inclusion criteria #2 and #8 which are not applicable to these subjects) and have an HbA1c ≤10% within 30 days of Day 1.
• +Completed all required study visits per protocol in the parent study
• +Subjects must be on standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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 reactionAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → associated with, attributed to, or caused by specific drug)
• +If the subject has a medical history of clinical atherosclerotic cardiovascular disease (ASCVD) or elevated 10-year ASCVD risk (eg, ≥7.5% per American Heart Association/American College of Cardiology \[AHA/ACC\] risk calculator for subjects ≥40 years of age or Framingham risk score calculator for subjects under the age of 40), the subject must be on appropriate lipid-lowering therapy as per local standard of care (ie, including moderate-to-high intensity statin, as indicated).
• +If the subject has diabetes:
• +Subject must be on optimized antidiabetic regimen as defined by the local standards, Investigator, and institutional practices
• +Subject must have no events of diabetic ketoacidosis, diabetic decompensation/ hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic controlControl groupThe group a new treatment is measured against.Read more → within 24 weeks of the Day 1 visit - Willing to follow diet counseling and maintain a stable low-fat diet
• +HbA1c ≤10% within 30 days prior to Day 1
• +Adult males, or nonpregnant (who do not plan to become pregnant), nonlactating adult females, who are able and willing to provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → prior to the performance of any study-specific procedures
• +Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 90 days after the End of Study (EOS) or the last dose of plozasiran, whichever is later. Male subjects must agree to use a condom during the study and for at least 90 days after the EOS or last dose of plozasiran whichever is later. Subjects must not donate sperm or eggs during the study and for at least 90 days after the EOS or last dose of plozasiran, whichever is later. Female subjects of childbearing potential on hormonal contraceptives must be stable on medication for \>1 menstrual cycle prior to Day 1.