Study of ARO-APOC3 in adults with dyslipidemia

Arrowhead Pharmaceuticals is starting a new clinical trial of Study of ARO-APOC3 in Adults With Dyslipidemia.

This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continue to meet eligibility criteria have the option to be enrolled into this study. Eligible enrolled participants will initially receive open-label ARO-APOC3 at the dose level assigned in the parent study until a final dose is selected, at which point all participants will receive open-label ARO-APOC3 at the same dosing regimen.

The clinical trial started in June 2022 and will continue throughout October 2025.

Number of Participants with Treatment-Emergent Adverse Events (TEAEs).

The inclusion parameter is Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study - Able and willing to provide written informed consent - Completed the 48-week study treatment period in the parent study Exclusion Criteria: - Subject was permanently discontinued from ARO-APOC3 in the parent study due to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) - Any new condition or worsening of existing condition or any other situation that 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 additional safety risk - Unwilling to limit alcohol consumption to within moderate limits for the duration of the study.

The excluding condition is Subject was permanently discontinued from ARO-APOC3 in the parent study due to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) - Any new condition or worsening of existing condition or any other situation that 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 additional safety risk - Unwilling to limit alcohol consumption to within moderate limits for the duration of the study.

For more details: https://ichgcp.net/clinical-trials-registry/NCT05413135 or clinicaltrials.gov/NCT05413135.

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