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: 100000004850; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2022-001135-85-HU
• Lead Sponsor: Arrowhead Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-29
• Last Update Posted: 29 July 2024

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).
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