Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia

Severe Hypertriglyceridemia Clinical Trial

— SHASTA-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720534
• Other study ID #: AROAPOC3-2001
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2024
• Source: Arrowhead Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: August 31, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Based on medical history, evidence of TG = 500 mg/dL and = 4000 mg/dL at Screening
• Fasting TG = 500 mg/dL at Screening
• Willing to follow diet counseling per Investigator judgment based on local standard of care
• Women of childbearing 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

Exclusion Criteria:

• Active pancreatitis within 12 weeks prior to first dose
• Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
• Acute coronary syndrome event within 24 weeks of first dose
• Major surgery within 12 weeks of first dose
• Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study
• Uncontrolled hypertension
• Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
• Uncontrolled hypothyroidism or hyperthyroidism
• Hemorrhagic stroke within 24 weeks of first dose
• Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply) Note: additional inclusion/exclusion criteria may apply per protocol

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Severe Hypertriglyceridemia

Intervention

Drug:
• ARO-APOC3
2 doses of ARO-APOC3 by subcutaneous (sc) injection
• Placebo
calculated volume to match active treatment by sc injection

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Core Research Group	Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Health	Clayton	Victoria
Australia	Linear Clinical Research	Perth	Nedlands
Australia	University of the Sunshine Coast	Sippy Downs	Queensland
Canada	Centre d'Etudes Cliniques ECOGENE-21	Chicoutimi	Quebec
Canada	LMC Diabetes & Endocrinology	Concord	Ontario
Canada	ViaCar Recherches Cliniques Inc.	Greenfield	Quebec
Canada	Lawson Health Research Institute	London	Ontario
Canada	Institut de Recherches Cliniques de Montreal	Montréal	Quebec
Canada	LMC Manna Research - Bayview	Toronto	Ontario
Germany	Uniklinik RWTH	Aachen
Germany	Universitatsklinikum Leipzig	Leipzig
Hungary	Lausmed Kft.	Baja
Hungary	Principal SMO Kft	Baja
Hungary	DRC Gyogyszervizsgalo Kozpont Balatonfured	Balatonföldvár
Hungary	Belgyogyaszati - Kardiologiai Maganrendelo	Bekescsaba
Hungary	Debreceni Egyetem	Debrecen
Hungary	Pharma4trial Ltd	Gyöngyös
Hungary	Selye Janos Korhaz	Komárom
Hungary	Borbanya Praxis Kft.	Nyiregyhaza
Hungary	Medifarma-98 Kft.	Nyíregyháza
Netherlands	Uni Van Amsterdam Academisch Medisch Centrum	Amsterdam
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	D&A Research	Sneek
New Zealand	Lipid and Diabetes Research Group	Christchurch
New Zealand	Auckland Clinical Studies	Grafton	Auckland
New Zealand	Lakeland Clinical Trials - Waikato	Hamilton
New Zealand	Middlemore Clinical Trials	Papatoetoe
New Zealand	Lakeland Clinical Trials - Rotorua	Rotorua
Poland	Spolka Lekarzy Intercor Sp.z.o.o.	Bydgoszcz
Poland	NZOZ TWOJE ZDROWIE EL Sp.z.o.o.	Elblag
Poland	Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek.	Gdynia
Poland	Zaklad Opieki Zdrowotnej Leczyca	Leczyca
Poland	All-MED Centrum Medyczne	Lódz
Poland	Medicome Sp. z.o.o.	Oswiecim
Poland	Praktyka Lekarska Ewa Krzyzagorska	Poznan
Poland	KO-MED M Konieczny Cent. Wielosp. Opieki	Pulawy
Poland	Centrum Medyczne Medyk	Rzeszów
Poland	Centrum Medyczne K2J2	Wolomin
United States	Northwest Heart Clinical Research	Arlington Heights	Illinois
United States	Westside Medical Associates of Los Angeles	Beverly Hills	California
United States	Preventive Cardiology Inc.	Boca Raton	Florida
United States	WR-CllinSearch, LLC	Chattanooga	Tennessee
United States	PriMed Clinical Research	Dayton	Ohio
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	Prestige Clinical Research	Franklin	Ohio
United States	Tribe Clinical Research	Greenville	South Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Glacier View Research Institute	Kalispell	Montana
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	The Research Group of Lexington, LLC	Lexington	Kentucky
United States	NYC Research, Inc.	Long Island City	New York
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Advanced Medical Research, LLC	Maumee	Ohio
United States	A Positive Research, Inc.	Miami	Florida
United States	AppleMed Research Group	Miami	Florida
United States	HeartWell LLP	Miami	Florida
United States	Y&L Advance Health care, Inc. D/B/A Elite Clinical Research	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	South Oklahoma Heart Research, LLC	Oklahoma City	Oklahoma
United States	Methodist Physicians Clinic Heart Consultants	Omaha	Nebraska
United States	Desert Oasis Healthcare (Desert Medical Group, Inc.)	Palm Springs	California
United States	Progressive Medical Research	Port Orange	Florida
United States	BFHC Research	San Antonio	Texas
United States	Cardiology Associates Research, LLC	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24		Baseline, Week 24
Secondary	Percent Change from Baseline in Fasting TG Over Time Through Week 48		Baseline, up to Week 48
Secondary	Percent Change from Baseline in Apolipoprotein (Apo)C-III at Week 24		Baseline, Week 24
Secondary	Percent Change from Baseline in ApoC-III Over Time Through Week 48		Baseline, up to Week 48
Secondary	Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24		Baseline, Week 24
Secondary	Percent Change from Baseline in Fasting Non-HDL-C Over Time Through Week 48		Baseline, up to Week 48
Secondary	Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24		Baseline, Week 24
Secondary	Percent Change from Baseline in Fasting HDL-C Over Time Through Week 48		Baseline, up to Week 48
Secondary	Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24		Baseline, Week 24
Secondary	Percent Change from Baseline in Fasting Total ApoB Over Time Through Week 48		Baseline, up to Week 48
Secondary	Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation		Baseline, Week 24
Secondary	Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Through Week 48		Baseline, up to Week 48
Secondary	Change from Baseline in Plasma Concentration of ARO-APOC3 Over Time Through Week 48		Baseline, up to Week 48
Secondary	Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) Possibly or Probably Related to Treatment		up to Week 48