A Long-Term Study to Evaluate ARO-APOC3 in Adults with Dyslipidemia

Phase 1

Conditions: Mixed Dyslipidemia
MedDRA version: 26.0Level: LLTClassification code 10027763Term: Mixed hyperlipidemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2022-001135-85-PL

Lead Sponsor: Arrowhead Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 582

Inclusion Criteria

1. Adults =18 years of age who are nonpregnant, nonlactating, and do not plan to become pregnant during the study

2. Able and willing to provide written informed consent prior to the performance of any study specific procedures

3. Completed the 48-week study treatment period in the parent study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 437
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 145

Exclusion Criteria

1. Subject was permanently discontinued from ARO-APOC3 in the parent study due to a. Elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT), or b. Elevated HbA1c (see Appendix 4 of Protocol Amendment 2.0 dated 22 November 2022).

2. 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

3. 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the safety and efficacy of long-term treatment with ARO-APOC3 in adults with dyslipidemia.;Secondary Objective: Not applicable;Primary end point(s): Subject incidence of treatment-emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: Month 1 and 2 and then every 3 months over 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Change and percent change from baseline over time in fasting TG<br>• Change and percent change from baseline over time in apolipoprotein (Apo)C-III<br>• Change and percent change from baseline over time in fasting non-high-density lipoprotein cholesterol (non-HDL-C)<br>• Change and percent change from baseline over time in fasting HDL-C<br>• Change and percent change from baseline over time in fasting total apolipoprotein B (ApoB)<br>• Change and percent change from baseline over time in fasting LDL-C using ultracentrifugation;Timepoint(s) of evaluation of this end point: Month 1 and 2 and then every 3 months over 24 months