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

Primary Purpose

Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ARO-ANG3
sterile normal saline (0.9% NaCl)
Sponsored by
Arrowhead Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Royal Prince Alfred Hospital
  • Royal Adelaide Hospital
  • Linear Clinical Research
  • Auckland Clinical Studies Limited
  • Middlemore Hospital
  • Lipid & Diabetes Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ARO-ANG3

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics (PK) of ARO-ANG3: Maximum Observed Plasma Concentration (Cmax)
PK of ARO-ANG3: Time to Maximum Plasma Concentration (Tmax)
PK of ARO-ANG3: Terminal Elimination Half-Life (t1/2)
PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to infinity (AUCinf)
Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline

Full Information

First Posted
November 16, 2018
Last Updated
September 20, 2021
Sponsor
Arrowhead Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03747224
Brief Title
Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
May 17, 2021 (Actual)
Study Completion Date
May 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arrowhead Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARO-ANG3
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ARO-ANG3
Intervention Description
single or multiple doses of ARO-ANG3 by subcutaneous (sc) injections
Intervention Type
Drug
Intervention Name(s)
sterile normal saline (0.9% NaCl)
Intervention Description
calculated volume to match active treatment
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Time Frame
Up to 113 (+/- 3 days) post-dose
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) of ARO-ANG3: Maximum Observed Plasma Concentration (Cmax)
Time Frame
Single dose phase: Up to 48 hours post-dose
Title
PK of ARO-ANG3: Time to Maximum Plasma Concentration (Tmax)
Time Frame
Single dose phase: Up to 48 hours post-dose
Title
PK of ARO-ANG3: Terminal Elimination Half-Life (t1/2)
Time Frame
Single dose phase: Up to 48 hours post-dose
Title
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
Title
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
Title
Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline
Time Frame
Baseline, Up to Day 113 (+/- 3 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Linear Clinical Research
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Auckland Clinical Studies Limited
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Middlemore Hospital
City
Papatoetoe
State/Province
Aukland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Lipid & Diabetes Research Group
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33900278
Citation
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.
Results Reference
derived

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

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