Clinical trial NCT05413135: Study of ARO-APOC3 in Adults With Dyslipidemia
Official title: A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Dyslipidemias
Lead sponsor: Arrowhead Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 continued to meet eligibility criteria had the option to be enrolled into this study. Eligible enrolled participants initially received open-label ARO-APOC3 every three or six months at the assigned dose level of the parent study until a final dose of 25 mg was selected, at which point all participants transitioned to the selected dosing regimen of 25 mg every 3 months.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Through 24 months
Secondary outcomes:
measure: Change from Baseline in Fasting Triglycerides (TG) Over Time
timeFrame: Through 24 months
measure: Percent Change from Baseline in Fasting TG Over Time
timeFrame: Through 24 months
measure: Change from Baseline in Apolipoprotein (Apo) C-III Over Time
timeFrame: Through 24 months
measure: Percent Change from Baseline in ApoC-III Over Time
timeFrame: Through 24 months
measure: Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time
timeFrame: Through 24 months
measure: Percent Change from Baseline in Fasting Non-HDL-C Over Time
timeFrame: Through 24 months
measure: Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
timeFrame: Through 24 months
measure: Percent Change from Baseline in Fasting HDL-C Over Time
timeFrame: Through 24 months
measure: Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
timeFrame: Through 24 months
measure: Percent Change from Baseline in Fasting Total ApoB Over Time
timeFrame: Through 24 months
measure: Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation
timeFrame: Through 24 months
measure: Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation
timeFrame: Through 24 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Westside Medical Associates of Los Angeles
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials; Inc.
state: California
city: Palm Springs
country: United States
facility: Desert Medical Group, Inc.
state: California
city: Boca Raton
country: United States
facility: Preventive Cardiology Inc.
state: Florida
city: Fort Lauderdale
country: United States
facility: Invesclinic U,S, LLC
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center Inc.
state: Florida
city: Miami
country: United States
facility: AppleMed Res Group
state: Florida
city: Miami
country: United States
facility: A Positive Research, Inc
state: Florida
city: Pembroke Pines
country: United States
facility: A&R Research Group
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Dunwoody
country: United States
facility: Alta Pharmaceutical Research Center
state: Georgia
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Assoc Res LLC
state: Mississippi
city: Omaha
country: United States
facility: Methodist Physicians Clinic Heart Consultants
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Res of South Nevada
state: Nevada
city: Long Island City
country: United States
facility: NYC Research Inc.
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research; PLLC
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai (ISMMS)
state: New York
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Marion
country: United States
facility: Marion Area Health Center
state: Ohio
city: Maumee
country: United States
facility: Advanced Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Res;LLC
state: Oklahoma
city: Greenville
country: United States
facility: Tribe Clinical Research
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Houston
country: United States
facility: East Texas Cardiology PA
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: San Antonio
country: United States
facility: BFHC Research
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Milton
country: Australia
facility: Core Research Group Pty Ltd
state: Queensland
city: Sippy Downs
country: Australia
facility: USC Clinical Trials - Sippy Downs
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Joondalup
country: Australia
facility: Genesis Care changing to Advara heartcare
state: Western Australia
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Concord
country: Canada
facility: LMC Clinical Research Inc
state: Ontario
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Chicoutimi
country: Canada
facility: Centre d'Etudes Cliniques ECOGENE-21
state: Quebec
city: Montréal
country: Canada
facility: Institut de Recherches Cliniques de Montreal
state: Quebec
city: Québec
country: Canada
facility: Recherche Clinique Sigma Inc
state: Quebec
city: Balatonfüred
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Balatonfured
city: Békéscsaba
country: Hungary
facility: Belgyogyaszati Kardiologiai Maganrendelo
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai K
city: Gyöngyös
country: Hungary
facility: Pharma4trial Ltd
city: Komárom
country: Hungary
facility: Selye Janos Korhaz
city: Nyíregyháza
country: Hungary
facility: Borbanya Praxis Kft
city: Amsterdam
country: Netherlands
facility: AMC
city: Sneek
country: Netherlands
facility: D and A Research
city: Zwijndrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Papatoetoe
country: New Zealand
facility: Middlemore Clinical Trials
state: Aukland
city: Christchurch
country: New Zealand
facility: NZCR OpCo Ltd
city: Christchurch
country: New Zealand
facility: Southern Clinical Trials Christchurch
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Intercor
city: Oświęcim
country: Poland
facility: Medicome Sp. z o.o.
city: Poznań
country: Poland
facility: Praktyka Lekarska Ewa Krzyzagorska
city: Rzeszów
country: Poland
facility: Centrum Medyczne Medyk
city: Łódź
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
city: Łódź
country: Poland
facility: All MED Centrum Medyczne
Study officials:
References: