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Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia (SHASTA-2)

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ClinicalTrials.gov Identifier: NCT04720534
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Study Description
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Brief Summary:
The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.

Condition or disease Intervention/treatment Phase
Severe Hypertriglyceridemia Drug: ARO-APOC3 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Severe Hypertriglyceridemia
Actual Study Start Date : May 31, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: ARO-APOC3
ARO-APOC3 Injection
 Drug: ARO-APOC3
2 doses of ARO-APOC3 by subcutaneous (sc) injection
Placebo Comparator: Placebo
Sterile Normal Saline (0.9% NaCl)
 Drug: Placebo
calculated volume to match active treatment by sc injection


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures :
  1. Percent Change from Baseline in Fasting TG Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
  2. Percent Change from Baseline in Apolipoprotein (Apo)C-III at Week 24 [ Time Frame: Baseline, Week 24 ]
  3. Percent Change from Baseline in ApoC-III Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
  4. Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 [ Time Frame: Baseline, Week 24 ]
  5. Percent Change from Baseline in Fasting Non-HDL-C Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
  6. Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24 [ Time Frame: Baseline, Week 24 ]
  7. Percent Change from Baseline in Fasting HDL-C Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
  8. Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24 [ Time Frame: Baseline, Week 24 ]
  9. Percent Change from Baseline in Fasting Total ApoB Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
  10. Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation [ Time Frame: Baseline, Week 24 ]
  11. Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
  12. Change from Baseline in Plasma Concentration of ARO-APOC3 Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
  13. Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) Possibly or Probably Related to Treatment [ Time Frame: up to Week 48 ]

Eligibility Criteria
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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:

  • Based on medical history, evidence of TG ≥ 500 mg/dL and ≤ 4000 mg/dL at Screening
  • Fasting TG ≥ 500 mg/dL at Screening
  • Willing to follow diet counseling per Investigator judgment based on local standard of care
  • Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
  • Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

  • Active pancreatitis within 12 weeks prior to first dose
  • Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
  • Acute coronary syndrome event within 24 weeks of first dose
  • Major surgery within 12 weeks of first dose
  • Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study
  • Uncontrolled hypertension
  • Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
  • Uncontrolled hypothyroidism or hyperthyroidism
  • Hemorrhagic stroke within 24 weeks of first dose
  • Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)

Note: additional inclusion/exclusion criteria may apply per protocol

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): NCT04720534


Contacts
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Contact: Medical Monitor 626-304-3400 AROAPOC@arrowheadpharma.com

Locations
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Sponsors and Collaborators
Arrowhead Pharmaceuticals
More Information
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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04720534    
Other Study ID Numbers: AROAPOC3-2001
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases