Study of ARO-ANG3 in Participants With Homozygous Familial Hypercholesterolemia (HOFH) (Gateway)

  • STATUS
    Recruiting
  • End date
    Oct 28, 2023
  • participants needed
    16
  • sponsor
    Arrowhead Pharmaceuticals
Updated on 28 July 2022

Summary

Participants with documented homozygous familial hypercholesterolemia (HoFH) who have provided informed consent will receive 2 open-label doses of ARO-ANG3 and be evaluated for safety and efficacy parameters through 36 weeks.

Details
Condition Homozygous Familial Hypercholesterolemia
Treatment ARO-ANG 3 Injection
Clinical Study IdentifierNCT05217667
SponsorArrowhead Pharmaceuticals
Last Modified on28 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Fasting LDL-C >100 mg/dL at Screening
Weight of ≥ 40 kg and body mass index ≥ 18.5 and ≤ 40 kg/m2
Diagnosis of HoFH based on a supportive genetic test or clinical diagnosis
On stable maximally tolerated lipid lowering therapy
Willing to abide by stable low-fat, low-cholesterol, heart-healthy diet for at least 4 weeks prior to Day 1
Participants of childbearing potential (males & females) must agree to use highly-effective contraception during the study and for at least 24 weeks from the last dose of study medication
Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
Women of childbearing potential on hormonal contraceptives must be stable on the medications 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 small interfering RNA oligonucleotides (siRNA) or antisense oligonucleoside molecule
Use of evinacumab (some exceptions apply)
Fasting TG > 300 mg/dL at Screening
Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
Newly diagnosed (within 3 months prior to informed consent) or poorly controlled diabetes (Hemoglobin A1c > 9%)
Use of systemic corticosteroids (some exceptions apply)
Symptoms of myocardial ischemia or severe left ventricular dysfunction
History of malignancy within 3 years of Day 1 (some exceptions apply)
Planned cardiac procedure/surgery such as coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), carotid surgery or stenting, or carotid revascularization
Note: additional inclusion/exclusion criteria may apply per protocol
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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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