A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia

Status: Active, not recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Based on medical history, evidence of TG ≥ 150 mg/dL but ≤ 499 mg/dL

• Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy

• Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 17 days apart

• Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care

• Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication

• Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding

• Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1

• Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication

• Able and willing to provide written informed consent and to comply with study requirements

Locations
United States
California
Velocity Clinical Research
Huntington Park
Florida
AGA Clinical Trials
Hialeah
Global Research Solutions
Miami
Progressive Medical Research
Port Orange
Minnesota
University of Minnesota
Minneapolis
North Carolina
Medication Management LLC
Greensboro
Lucas Research, Inc.
Morehead City
Nebraska
Methodist Physicians Clinic Heart Consultants
Omaha
Nevada
Clinical Research of South Nevada
Las Vegas
New York
Icahn School of Medicine at Mount Sinai (ISMMS)
New York
Ohio
Marion Area Health Center
Marion
Pennsylvania
Capital Area Research, LLC
Camp Hill
Texas
Baylor College of Medicine
Houston
Other Locations
Australia
Paratus Clinical Research
Blacktown
Linear Clinical Research
Nedlands
University of the Sunshine Coast Clinical Trials Centre
Sippy Downs
Canada
Centre d'Etudes Cliniques
Chicoutimi
Lawson Health Research Institute
London
Ctr de Recherche Clin de Laval
Québec
Recherche Clinique Sigma Inc
Québec
New Zealand
Lakeland Clinical Trials - Waitemata
Birkenhead
NZCR OpCo Ltd.
Christchurch
Lakeland Clinical Trials - Waikato
Hamilton
Lakeland Clinical Trials - Rotorua
Rotorua
Time Frame
Start Date: June 28, 2021
Estimated Completion Date: December 2024
Participants
Target number of participants: 204
Treatments
Experimental: ARO-ANG3
Two doses of ARO-ANG3 by subcutaneous (sc) injection during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Placebo Comparator: Placebo
Calculated volume to match active treatment by sc injection during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Sponsors
Leads: Arrowhead Pharmaceuticals

This content was sourced from clinicaltrials.gov

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