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

  • STATUS
    Recruiting
  • End date
    Jul 9, 2023
  • participants needed
    320
  • sponsor
    Arrowhead Pharmaceuticals
Updated on 9 August 2022

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.

Details
Condition Mixed Dyslipidemia
Treatment Placebo, ARO-APOC3
Clinical Study IdentifierNCT04998201
SponsorArrowhead Pharmaceuticals
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

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
Willing to provide written informed consent and to comply with study requirements
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

Exclusion Criteria

Active pancreatitis within 12 weeks prior to Day 1
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
Uncontrolled hypertension
Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or
Uncontrolled hypothyroidism or hyperthyroidism
antisense oligonucleotide molecule
Hemorrhagic stroke within 24 weeks of Day 1
History of bleeding diathesis or coagulopathy
Any planned bariatric surgery or similar procedures to induce weight loss from consent
through end of study
Current diagnosis of nephrotic syndrome
Note: additional inclusion/exclusion criteria may apply per protocol
New York Heart Association Class II, III or IV heart failure or last known ejection
fraction of <30%
Known history of human immunodeficiency virus (HIV) infection, seropositive for
Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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