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Study of ARO-APOC3 in Adults With Dyslipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05413135
Recruitment Status : Active, not recruiting
First Posted : June 9, 2022
Last Update Posted : October 25, 2023
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Study Description
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Brief Summary:
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 assigned dose level until a final dose is selected, at which point all participants will be transitioned to the selected dosing regimen.

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: ARO-APOC3 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia
Actual Study Start Date : July 7, 2022
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: ARO-APOC3
1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 or 6 months
 Drug: ARO-APOC3
ARO-APOC3 Injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Through 24 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05413135


Locations
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Sponsors and Collaborators
Arrowhead Pharmaceuticals
More Information
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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05413135    
Other Study ID Numbers: AROAPOC3-2003
First Posted: June 9, 2022    Key Record Dates
Last Update Posted: October 25, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases