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Completed

NCT Number: NCT05413135

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 continued to meet eligibility criteria had the option to be enrolled into this study. Eligible enrolled participants initially received open-label ARO-APOC3 every three or six months at the assigned dose level of the parent study until a final dose of 25 mg was selected, at which point all participants transitioned to the selected dosing regimen of 25 mg every 3 months.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Site 32, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 glycated hemoglobin (HbA1c), 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

Treatment and study plan

ARO-APOC3

Drug

ARO-APOC3 Injection

Primary outcomes

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

    Time frame: Through 24 months

Secondary outcomes

  1. Change from Baseline in Fasting Triglycerides (TG) Over Time

    Time frame: Through 24 months

  2. Percent Change from Baseline in Fasting TG Over Time

    Time frame: Through 24 months

  3. Change from Baseline in Apolipoprotein (Apo) C-III Over Time

    Time frame: Through 24 months

  4. Percent Change from Baseline in ApoC-III Over Time

    Time frame: Through 24 months

  5. Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time

    Time frame: Through 24 months

  6. Percent Change from Baseline in Fasting Non-HDL-C Over Time

    Time frame: Through 24 months

  7. Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time

    Time frame: Through 24 months

  8. Percent Change from Baseline in Fasting HDL-C Over Time

    Time frame: Through 24 months

  9. Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time

    Time frame: Through 24 months

  10. Percent Change from Baseline in Fasting Total ApoB Over Time

    Time frame: Through 24 months

  11. Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation

    Time frame: Through 24 months

  12. Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation

    Time frame: Through 24 months

Sponsors and collaborators

Lead sponsor

Arrowhead Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2022
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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