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Study to Evaluate Plozasiran in Adults with Hypertriglyceridemia (SHASTA-10 Study)
EU CTIS ID: 2024-519712-13-00
What this study is testing
To demonstrate the long-term safety of plozasiran in subjects with HTG and SHTG.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (i.e. AROAPOC3-3001 [Canada and Japan only], AROAPOC3-3003, AROAPOC3-3004, or AROAPOC3-3009).
- 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 EOS or the last dose of IMP, whichever is later. Male subjects must agree to use a condom during the study and for at least 90 days after the EOS or the last dose of IMP, 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 IMP, whichever is later. Female subjects of childbearing potential on hormonal contraceptives must be stable on the medication for >1 menstrual cycle prior to Day 1 (V1).
You likely can't join if
- Subject was permanently discontinued from receiving IMP in the parent study due to elevated AST or 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
- Any new condition or worsening of existing condition (eg, renal, hematologic, gastrointestinal, endocrine, cardiovascular, pulmonary, immunologic, psychiatric) 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. Moderate limits are defined as follows: no more than 14 units per week (1 unit approximately corresponds to 80 mL of wine, 200 mL of beer, or 25 mL of 40% alcohol).
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Argentina
- Australia
- China
- Brazil
- Japan
- United States
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Argentina; Australia; China; Brazil; Japan and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.