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Study of ARO-APOC3 in Adults With Mixed Dyslipidemia (MUIR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04998201
Recruitment Status : Recruiting
First Posted : August 10, 2021
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Brief Summary:
Participants who have met all protocol eligibility criteria will be randomly assigned to treatment (ARO-APOC3 or placebo) in a double-blind fashion and will be evaluted for safety and efficacy over 48 weeks. Participants will be counseled to remain on a specified diet throughout the study, as recommended by the Investigator in accordance with local standard of care. After week 48, participants will be eligible and invited to consent and continue in an open-label extension study. All placebo participants who opt to continue will switch to active drug (ARO-APOC3) during the extension study.

Condition or disease Intervention/treatment Phase
Mixed Dyslipidemia Drug: ARO-APOC3 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 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 Mixed Dyslipidemia
Actual Study Start Date : September 28, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Arm Intervention/treatment
Experimental: ARO-APOC3
2 doses of ARO-APOC3 by subcutaneous (sc) injection
Drug: ARO-APOC3
ARO-APOC3 Injection

Placebo Comparator: Placebo
calculated volume to match active treatment by sc injection
Drug: Placebo
Sterile Normal Saline (0.9% NaCl)




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 [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 36, 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 [ 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 form Baseline in Non-HDL-C Over Time [ 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 HDL-C Over Time [ 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 ApoB Over Time [ Time Frame: Baseline, up to Week 48 ]
  10. Percent Change from Baseline in Fasting Total Low Density Lipoprotein Cholesterol (LDL-C) Using Ultracentrifugation at Week 24 [ Time Frame: Baseline, Week 24 ]
  11. Percent Change from Baseline in Fasting Total LDL-C Using Ultracentrifugation Over Time [ Time Frame: Baseline, up to Week 48 ]
  12. Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Week 24 [ Time Frame: Week 24 ]
  13. Number of Participants with Treatment- Emergent AEs and/or SAEs Through Week 48 [ Time Frame: up to Week 48 ]
  14. Change from Baseline in Plasma Concentrations of ARO-APOC3 Over Time [ Time Frame: up to Week 24 ]
  15. Pharmacokinetics (PK) of ARO-APOC3: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: up to Week 24 ]
  16. PK of ARO-APOC3: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: up to Week 24 ]
  17. PK of ARO-APOC3: Area Under the Plasma Concentration Versus Time Curve From Zero to Time of Last Measurable Concentration (AUClast) [ Time Frame: up to Week 24 ]


Information from the National Library of Medicine

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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 ≥ 150 mg/dL but ≤ 499 mg/dL on more than one occasion

  • Fasting levels at Screening of non-HDL-C ≥ 100 mg/dL OR LDL-C ≥ 70 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy
  • Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 14 days apart
  • Willing to follow diet counseling as per Investigator judgment based on local standard of care
  • Participants of childbearing potential (males & females) must use highly-effective contraception during the study and for at least 24 weeks following the last dose of study medication. Males must not donate sperm and females must ot donate eggs during the study and for at least 24 weeks following the last dose of study medication.
  • Women of childbearing potential must have a negative pregnancy test at Screening and cannot be breastfeeding
  • Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
  • Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

  • Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule
  • Active pancreatitis within 12 weeks prior to Day 1
  • Any planned bariatric surgery or similar procedures to induce weight loss from consent through end of study
  • Acute coronary syndrome event within 24 weeks of Day 1
  • Major surgery within 12 weeks of Day 1
  • Planned coronary intervention (e.g., stent placement or heart bypass) during the study
  • New York Heart Association Class II, III or IV heart failure or last known ejection fraction of <30%
  • Uncontrolled hypertension
  • Known history of 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 Day 1
  • History of bleeding diathesis or coagulopathy
  • Current diagnosis of nephrotic syndrome
  • Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study
  • 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


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): NCT04998201


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

Locations
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Sponsors and Collaborators
Arrowhead Pharmaceuticals
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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04998201    
Other Study ID Numbers: AROAPOC3-2002
2021-000688-57 ( EudraCT Number )
First Posted: August 10, 2021    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
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