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

Phase 1

Completed

• Conditions: Dyslipidemias; Familial Hypercholesterolemia; Hypertriglyceridemia
• Interventions: Drug: ARO-ANG3; Drug: sterile normal saline (0.9% NaCl)

• Registration Number: NCT03747224
• Lead Sponsor: Arrowhead Pharmaceuticals

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-20
• Study Start: 2019-01-07
• Primary Completion: 2021-05-17
• Study Completion: 2021-05-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ARO-ANG3	ARO-ANG3	-
Placebo	sterile normal saline (0.9% NaCl)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment	Up to 113 (+/- 3 days) post-dose

Secondary Outcome Measures

Name	Time	Method
PK of ARO-ANG3: Time to Maximum Plasma Concentration (Tmax)	Single dose phase: Up to 48 hours post-dose
Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline	Baseline, Up to Day 113 (+/- 3 days)
PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)	Single dose phase: Up to 48 hours post-dose
Pharmacokinetics (PK) of ARO-ANG3: Maximum Observed Plasma Concentration (Cmax)	Single dose phase: Up to 48 hours post-dose
PK of ARO-ANG3: Terminal Elimination Half-Life (t1/2)	Single dose phase: Up to 48 hours post-dose
PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to infinity (AUCinf)	Single dose phase: Up to 48 hours post-dose

Trial Locations

Locations (6)

Linear Clinical Research; 🇦🇺 Nedlands, Australia

Auckland Clinical Studies Limited; 🇳🇿 Grafton, Auckland, New Zealand

Middlemore Hospital; 🇳🇿 Papatoetoe, Aukland, New Zealand

Lipid & Diabetes Research Group; 🇳🇿 Christchurch, New Zealand

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia