Study of ARO-APOC3 in Adults With Dyslipidemia

Dyslipidemias Clinical Trial

Official title:

A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05413135
• Other study ID #: AROAPOC3-2003
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 7, 2022
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: Arrowhead Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continue to meet eligibility criteria have the option to be enrolled into this study. Eligible enrolled participants will initially receive open-label ARO-APOC3 at the assigned dose level until a final dose is selected, at which point all participants will be transitioned to the selected dosing regimen.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 418
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study

• Able and willing to provide written informed consent

• Completed the 48-week study treatment period in the parent study

Exclusion Criteria:

• Subject was permanently discontinued from ARO-APOC3 in the parent study due to elevated glycated hemoglobin (HbA1c), aspartate aminotransferase (AST) or alanine aminotransferase (ALT)

• Any new condition or worsening of existing condition or any other situation that would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements or put the subject at additional safety risk

• Unwilling to limit alcohol consumption to within moderate limits for the duration of the study

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• ARO-APOC3
ARO-APOC3 Injection

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Health	Clayton	Victoria
Australia	Genesis Care changing to Advara heartcare	Joondalup	Western Australia
Australia	Core Research Group Pty Ltd	Milton	Queensland
Australia	Linear Clinical Research	Nedlands	Western Australia
Australia	USC Clinical Trials - Sippy Downs	Sippy Downs	Queensland
Canada	Centre d'Etudes Cliniques ECOGENE-21	Chicoutimi	Quebec
Canada	LMC Clinical Research Inc	Concord	Ontario
Canada	ViaCar Recherches Cliniques Inc.	Greenfield Park	Quebec
Canada	Lawson Health Research Institute	London	Ontario
Canada	Institut de Recherches Cliniques de Montreal	Montréal	Quebec
Canada	Recherche Clinique Sigma Inc	Québec	Quebec
Hungary	Lausmed Kft	Baja
Hungary	DRC Gyogyszervizsgalo Kozpont Balatonfured	Balatonfüred
Hungary	Belgyogyaszati Kardiologiai Maganrendelo	Békéscsaba
Hungary	Debreceni Egyetem Klinikai K	Debrecen
Hungary	Pharma4trial Ltd	Gyöngyös
Hungary	Selye Janos Korhaz	Komárom
Hungary	Borbanya Praxis Kft	Nyíregyháza
Netherlands	AMC	Amsterdam
Netherlands	D and A Research	Sneek
Netherlands	Albert Schweitzer Ziekenhuis	Zwijndrecht
New Zealand	NZCR OpCo Ltd	Christchurch
New Zealand	Southern Clinical Trials Christchurch	Christchurch
New Zealand	Middlemore Clinical Trials	Papatoetoe	Aukland
Poland	Centrum Medyczne Intercor	Bydgoszcz
Poland	All MED Centrum Medyczne	Lódz
Poland	Instytut Centrum Zdrowia Matki Polki	Lódz
Poland	Medicome Sp. z o.o.	Oswiecim
Poland	Praktyka Lekarska Ewa Krzyzagorska	Poznan
Poland	Centrum Medyczne Medyk	Rzeszów
United States	Westside Medical Associates of Los Angeles	Beverly Hills	California
United States	Preventive Cardiology Inc.	Boca Raton	Florida
United States	ClinSearch, LLC	Chattanooga	Tennessee
United States	Alta Pharmaceutical Research Center	Dunwoody	Georgia
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Invesclinic U,S, LLC	Fort Lauderdale	Florida
United States	Tribe Clinical Research	Greenville	South Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	East Texas Cardiology PA	Houston	Texas
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Clinical Res of South Nevada	Las Vegas	Nevada
United States	NYC Research Inc.	Long Island City	New York
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Marion Area Health Center	Marion	Ohio
United States	Advanced Medical Research	Maumee	Ohio
United States	A Positive Research, Inc	Miami	Florida
United States	AppleMed Res Group	Miami	Florida
United States	Y and L Advance Health Care	Miami	Florida
United States	Ocean Blue Medical Research Center Inc.	Miami Springs	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Lucas Research, Inc.	Morehead City	North Carolina
United States	Mid Hudson Medical Research; PLLC	New Windsor	New York
United States	Icahn School of Medicine at Mount Sinai (ISMMS)	New York	New York
United States	Valley Clinical Trials; Inc.	Northridge	California
United States	South Oklahoma Heart Res;LLC	Oklahoma City	Oklahoma
United States	Methodist Physicians Clinic Heart Consultants	Omaha	Nebraska
United States	Desert Medical Group, Inc.	Palm Springs	California
United States	A&R Research Group	Pembroke Pines	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	BFHC Research	San Antonio	Texas
United States	Cardiology Assoc Res LLC	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Hungary,  Netherlands,  New Zealand,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment-Emergent Adverse Events (TEAEs)		Through 24 months
Secondary	Change from Baseline in Fasting Triglycerides (TG) Over Time		Through 24 months
Secondary	Percent Change from Baseline in Fasting TG Over Time		Through 24 months
Secondary	Change from Baseline in Apolipoprotein (Apo) C-III Over Time		Through 24 months
Secondary	Percent Change from Baseline in ApoC-III Over Time		Through 24 months
Secondary	Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time		Through 24 months
Secondary	Percent Change from Baseline in Fasting Non-HDL-C Over Time		Through 24 months
Secondary	Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time		Through 24 months
Secondary	Percent Change from Baseline in Fasting HDL-C Over Time		Through 24 months
Secondary	Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time		Through 24 months
Secondary	Percent Change from Baseline in Fasting Total ApoB Over Time		Through 24 months
Secondary	Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation		Through 24 months
Secondary	Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation		Through 24 months