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

Arrowhead Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Dyslipidemias

Hypertriglyceridemia

Familial Hypercholesterolemia

Treatments

Drug: ARO-ANG3

Drug: sterile normal saline (0.9% NaCl)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03747224

AROANG1001

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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