A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (SHASTA-10 Study) (SHASTA-10 Study)

Not provided0 sites3 target enrollmentStarted: TBD

ConditionsHypertriglyceridemia

Overview

Phase: Not Applicable
Status: Recruiting
Enrollment: 3

Overview Study Design Eligibility Criteria Investigators Records & Identifiers Similar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional
Allocation: Non Randomized

Eligibility Criteria

Ages: 18age old over to No limit (—)
Sex: All

Inclusion Criteria

•Adult males, or nonpregnant (who do not plan to become pregnant), nonlactating adult females, who are able and willing to provide written informed consent prior to the performance of any study-specific procedures
•Completed all required study visits per protocol in the parent study
•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
•Subjects must be on standard of care lipid and TG-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)
•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 control within 24 weeks of the Day 1 visit - Willing to follow diet counseling and maintain a stable low-fat diet
•Subjects in the USA and Canada who completed protocol AROAPOC3-2003 meeting all eligibility criteria (with the exception of inclusion criteria #9 which is not applicable to these subjects) who also meet the following additional criteria may enroll in this trial:
•HbA1c =<10% within 30 days prior to Day 1

Exclusion Criteria

•Subject was permanently discontinued from receiving plozasiran in the parent study due to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or due to HbA1c elevation that did not respond to antidiabetic regimen
•Subject withdrew consent for continued study treatment in the parent study
•Known hypersensitivity to the active substance or to any of the excipients of plozasiran
•Known hypersensitivity to the active substance or to any of the excipients of plozasiran
•Any new condition or worsening of existing condition or any other situation that in the Investigator's judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements, or put the subject at an additional safety risk
•Unwilling to limit alcohol consumption to within moderate limits for the duration of the study.
•Poorly controlled glycemia (ie, HbA1c >10%) based upon the most recent HbA1c level reported in the parent trial prior to Day 1
•Acute pancreatitis within 4 weeks prior to Day 1
•Use of any hepatocyte-targeted siRNA that targets lipids and/or triglycerides within 365 days before Day 1 (except plozasiran or inclisiran, which are permitted). Administration of inclisiran must be separated from administration of plozasiran by at least 4 weeks throughout the treatment period
•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 PK, whichever is longer.

Investigators

Sponsor

Not provided

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