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Completed

NCT Number: NCT03747224

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

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.

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Key information

Conditions

Dyslipidemias Congenital, Hereditary, and Neonatal Diseases and Abnormalities Familial Hypercholesterolemia Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Hypertriglyceridemia Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site 2, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

NOTE: additional inclusion/exclusion criteria may apply, per protocol

Treatment and study plan

ARO-ANG3

Drug

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

Sterile Normal Saline (0.9% NaCl)

Drug

calculated volume to match active treatment

Primary outcomes

  1. Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment

    Time frame: Up to 113 (+/- 3 days) post-dose

Secondary outcomes

  1. Pharmacokinetics (PK) of ARO-ANG3: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Single dose phase: Up to 48 hours post-dose

  2. PK of ARO-ANG3: Time to Maximum Plasma Concentration (Tmax)

    Time frame: Single dose phase: Up to 48 hours post-dose

  3. PK of ARO-ANG3: Terminal Elimination Half-Life (t1/2)

    Time frame: Single dose phase: Up to 48 hours post-dose

  4. PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)

    Time frame: Single dose phase: Up to 48 hours post-dose

  5. PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to infinity (AUCinf)

    Time frame: Single dose phase: Up to 48 hours post-dose

  6. Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline

    Time frame: Baseline, Up to Day 113 (+/- 3 days)

Sponsors and collaborators

Lead sponsor

Arrowhead Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1 Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-ANG3 in Adult Healthy Volunteers and in Dyslipidemic Patients

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2018
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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