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Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients

NCT ID: NCT03747224

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2021-05-17

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial hypercholesterolemia and severe hypertriglyceridemia.

Detailed Description

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Conditions

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Dyslipidemias Familial Hypercholesterolemia Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ARO-ANG3

Group Type EXPERIMENTAL

ARO-ANG3

Intervention Type DRUG

single or multiple doses of ARO-ANG3 by subcutaneous (sc) injections

Placebo

Group Type PLACEBO_COMPARATOR

sterile normal saline (0.9% NaCl)

Intervention Type DRUG

calculated volume to match active treatment

Interventions

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ARO-ANG3

single or multiple doses of ARO-ANG3 by subcutaneous (sc) injections

Intervention Type DRUG

sterile normal saline (0.9% NaCl)

calculated volume to match active treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women of child bearing 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
* On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
* Normal electrocardiogram (ECG) at Screening

Exclusion Criteria

* Clinically significant health concerns
* Regular use of alcohol within one month prior to Screening
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
* Recent use of illicit drugs
* Use of more than two tobacco/nicotine containing or cannabis products per month within 6 months prior to drug administration (applicable only to Normal Healthy Volunteers)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arrowhead Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site 2

Camperdown, New South Wales, Australia

Site Status

Research Site 3

Adelaide, South Australia, Australia

Site Status

Research Site 1

Nedlands, , Australia

Site Status

Research Site 4

Grafton, Auckland, New Zealand

Site Status

Research Site 5

Papatoetoe, Aukland, New Zealand

Site Status

Research Site 6

Christchurch, , New Zealand

Site Status

Countries

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Australia New Zealand

References

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Watts GF, Schwabe C, Scott R, Gladding PA, Sullivan D, Baker J, Clifton P, Hamilton J, Given B, Melquist S, Zhou R, Chang T, San Martin J, Gaudet D, Goldberg IJ, Knowles JW, Hegele RA, Ballantyne CM. RNA interference targeting ANGPTL3 for triglyceride and cholesterol lowering: phase 1 basket trial cohorts. Nat Med. 2023 Sep;29(9):2216-2223. doi: 10.1038/s41591-023-02494-2. Epub 2023 Aug 25.

Reference Type DERIVED
PMID: 37626170 (View on PubMed)

Ying Q, Chan DC, Watts GF. Angiopoietin-like protein 3 inhibitors and contemporary unmet needs in lipid management. Curr Opin Lipidol. 2021 Jun 1;32(3):210-212. doi: 10.1097/MOL.0000000000000747. No abstract available.

Reference Type DERIVED
PMID: 33900278 (View on PubMed)

Other Identifiers

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AROANG1001

Identifier Type: -

Identifier Source: org_study_id