Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Launched by ARROWHEAD PHARMACEUTICALS · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a treatment called plozasiran for adults with high triglyceride levels, a condition known as hypertriglyceridemia. The trial is open to adults who have previously participated in specific parent studies and will receive plozasiran through an injection under the skin about every three months for two years. Participants will also be encouraged to follow a low-fat diet throughout the study.

To be eligible for this trial, participants must be adult males or nonpregnant women who can provide consent and have completed all required visits in the earlier studies. They should not have any serious liver issues or other health conditions that would make it unsafe for them to participate. It's important for participants to agree to use effective birth control methods if they could become pregnant during the study. This trial is not yet recruiting, so participants will have to wait until it officially starts.

Gender

ALL

Eligibility criteria

• 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 AROAPOC3-3001, 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 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.
• 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
• • 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.
• • Note: Other inclusion/exclusion criteria may apply per protocol