A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults with Dyslipidemia - AROAPOC3-2003

Arrowhead Pharmaceuticals Inc.0 个研究点目标入组 442 人开始时间: 2024年5月21日最近更新: 2024年8月21日

适应症

试验速览

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•Adults =18 years of age who are nonpregnant, nonlactating, and do not plan to become pregnant during the study, Able and willing to provide written informed consent prior to the performance of any study specific procedures, Completed the 48-week study treatment period in the parent study

•Subject was permanently discontinued from ARO-APOC3 in the parent study due to: a. Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT), or b. Elevated HbA1c. (hemoglobin A1c)., 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 additional safety risk, Unwilling to limit alcohol consumption to within moderate limits for the duration of the study, as follows: not 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)

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