A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Mixed Dyslipidemia

Status: Active, not recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Participants who have met all protocol eligibility criteria will be randomly assigned to treatment (ARO-APOC3 or placebo) in a double-blind fashion and will be evaluted for safety and efficacy over 48 weeks. Participants will be counseled to remain on a specified diet throughout the study, as recommended by the Investigator in accordance with local standard of care. After week 48, participants will be eligible and invited to consent and continue in an open-label extension study. All placebo participants who opt to continue will switch to active drug (ARO-APOC3) during the extension study.

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 on more than one occasion

• Fasting levels at Screening of non-HDL-C ≥ 100 mg/dL OR LDL-C ≥ 70 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 14 days apart

• Willing to follow diet counseling as per Investigator judgment based on local standard of care

• Participants of childbearing potential (males & females) must use highly-effective contraception during the study and for at least 24 weeks following the last dose of study medication. Males must not donate sperm and females must ot donate eggs during the study and for at least 24 weeks following the last dose of study medication.

• Women of childbearing potential must have a negative pregnancy test at Screening 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

• Willing to provide written informed consent and to comply with study requirements

Locations
United States
California
Westside Medical Associates of Los Angeles
Beverly Hills
Valley Clinical Trials, Inc
Northridge
Florida
Preventive Cardiology Inc.
Boca Raton
Invesclinic U.S.; LLC
Fort Lauderdale
Ocean Blue Medical Research Center, Inc.
Miami Springs
A & R Research Group
Pembroke Pines
Georgia
Alta Pharmaceutical Research Center
Dunwoody
Nevada
Clinical Research of South Nevada
Las Vegas
New York
Mid Hudson Medical Research, PLLC
New Windsor
Ohio
Primed Clinical Research
Dayton
Prestige Clinical Research
Franklin
South Carolina
Tribe Clinical Research
Greenville
Texas
Baylor College of Medicine
Houston
East Texas Cardiology PA
Houston
BFHC Research
San Antonio
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Monash Health
Clayton
Genesis Care Joondalup
Joondalup
University of Sunshine Coast Morayfield
Morayfield
Canada
LMC Diabetes & Endocrinology
Concord
Institut de Recherches Cliniques de Montreal
Montréal
Hungary
DRC Gyogyszervizsgalo
Balatonfüred
University of Debrecen-Clinical Center
Debrecen
Borbanya Praxis Kft.
Nyiregyhaza
New Zealand
Middlemore Hospital
Auckland
Southern Clinical Trials Christchurch
Christchurch
Poland
All-MED Centrum Medyczne
Łódź
Instytut Centrum Zdrowia Matki Polki
Łódź
Praktyka Lekarska Ewa Krzyzagorska
Poznań
Centrum Medyczne Medyk
Rzeszów
Time Frame
Start Date: September 28, 2021
Estimated Completion Date: July 2023
Participants
Target number of participants: 353
Treatments
Experimental: ARO-APOC3
2 doses of ARO-APOC3 by subcutaneous (sc) injection
Placebo Comparator: Placebo
calculated volume to match active treatment by sc injection
Authors
William Randall, Alan Miller, Seth J Baum, Ronald Mayfield, Matthew Teltser, Masoud Azizad, Bernard Garcia, Gary Bedel, Sashi Makam, Ronald Goldenberg, Roger Estevez, David Sullivan, Norman Lepor, Anwar Ahmad, Marcin Ogorek, Ewa Krzyzagorska, Sophie Bernard, Katalin Bezzegh, Ramon Reyes, Joanna Wojciechowska, Nischal Sahai, Antonio Terrlonge, Stanislaw Mazur, Szilard Vasas, Peter Clifton, Simon Carson, Peter Purnell, Denes Pall, Maciej Banach, Stephen Nicholls
Sponsors
Leads: Arrowhead Pharmaceuticals

This content was sourced from clinicaltrials.gov

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