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Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia (SHASTA-2)

Primary Purpose

Severe Hypertriglyceridemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ARO-APOC3
Placebo
Sponsored by
Arrowhead Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Hypertriglyceridemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westside Medical Associates of Los Angeles
  • Desert Oasis Healthcare (Desert Medical Group, Inc.)
  • Preventive Cardiology Inc.
  • Invesclinic U.S., LLC
  • Ocean Blue Medical Research Center Inc.
  • A Positive Research, Inc.
  • Y&L Advance Health care, Inc. D/B/A Elite Clinical Research
  • AppleMed Research Group
  • HeartWell LLP
  • Progressive Medical Research
  • Alta Pharmaceutical Research Center
  • Northwest Heart Clinical Research
  • The Research Group of Lexington, LLC
  • University of Minnesota
  • Cardiology Associates Research, LLC
  • Glacier View Research Institute
  • Methodist Physicians Clinic Heart Consultants
  • Clinical Research of South Nevada
  • NYC Research, Inc.
  • Mid Hudson Medical Research, PLLC
  • Icahn School of Medicine at Mount Sinai (ISMMS)
  • Lucas Research, Inc
  • Lillestol Research LLC
  • PriMed Clinical Research
  • Prestige Clinical Research
  • Advanced Medical Research, LLC
  • South Oklahoma Heart Research, LLC
  • Tribe Clinical Research
  • WR-CllinSearch, LLC
  • Baylor College of Medicine
  • Pioneer Research Solutions, Inc.
  • BFHC Research
  • Manassas Clinical Research Center
  • Linear Clinical Research
  • Royal Prince Alfred Hospital
  • Core Research Group
  • University of the Sunshine Coast
  • Royal Adelaide Hospital
  • Monash Health
  • LMC Diabetes & Endocrinology
  • Lawson Health Research Institute
  • LMC Manna Research - Bayview
  • Centre d'Etudes Cliniques ECOGENE-21
  • ViaCar Recherches Cliniques Inc.
  • Institut de Recherches Cliniques de Montreal
  • Uniklinik RWTH
  • Universitatsklinikum Leipzig
  • Lausmed Kft.
  • Principal SMO Kft
  • DRC Gyogyszervizsgalo Kozpont Balatonfured
  • Belgyogyaszati - Kardiologiai Maganrendelo
  • Debreceni Egyetem
  • Pharma4trial Ltd
  • Selye Janos Korhaz
  • Borbanya Praxis Kft.
  • Medifarma-98 Kft.
  • Uni Van Amsterdam Academisch Medisch Centrum
  • Albert Schweitzer Ziekenhuis
  • D&A Research
  • Auckland Clinical Studies
  • Lipid and Diabetes Research Group
  • Lakeland Clinical Trials - Waikato
  • Middlemore Clinical Trials
  • Lakeland Clinical Trials - Rotorua
  • Spolka Lekarzy Intercor Sp.z.o.o.
  • NZOZ TWOJE ZDROWIE EL Sp.z.o.o.
  • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek.
  • Zaklad Opieki Zdrowotnej Leczyca
  • Medicome Sp. z.o.o.
  • Praktyka Lekarska Ewa Krzyzagorska
  • KO-MED M Konieczny Cent. Wielosp. Opieki
  • Centrum Medyczne Medyk
  • Centrum Medyczne K2J2
  • All-MED Centrum Medyczne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ARO-APOC3

Placebo

Arm Description

ARO-APOC3 Injection

Sterile Normal Saline (0.9% NaCl)

Outcomes

Primary Outcome Measures

Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2021
Last Updated
September 1, 2023
Sponsor
Arrowhead Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04720534
Brief Title
Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arrowhead Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARO-APOC3
Arm Type
Experimental
Arm Description
ARO-APOC3 Injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sterile Normal Saline (0.9% NaCl)
Intervention Type
Drug
Intervention Name(s)
ARO-APOC3
Intervention Description
2 doses of ARO-APOC3 by subcutaneous (sc) injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
calculated volume to match active treatment by sc injection
Primary Outcome Measure Information:
Title
Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Percent Change from Baseline in Fasting TG Over Time Through Week 48
Time Frame
Baseline, up to Week 48
Title
Percent Change from Baseline in Apolipoprotein (Apo)C-III at Week 24
Time Frame
Baseline, Week 24
Title
Percent Change from Baseline in ApoC-III Over Time Through Week 48
Time Frame
Baseline, up to Week 48
Title
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
Time Frame
Baseline, Week 24
Title
Percent Change from Baseline in Fasting Non-HDL-C Over Time Through Week 48
Time Frame
Baseline, up to Week 48
Title
Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24
Time Frame
Baseline, Week 24
Title
Percent Change from Baseline in Fasting HDL-C Over Time Through Week 48
Time Frame
Baseline, up to Week 48
Title
Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24
Time Frame
Baseline, Week 24
Title
Percent Change from Baseline in Fasting Total ApoB Over Time Through Week 48
Time Frame
Baseline, up to Week 48
Title
Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation
Time Frame
Baseline, Week 24
Title
Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Through Week 48
Time Frame
Baseline, up to Week 48
Title
Change from Baseline in Plasma Concentration of ARO-APOC3 Over Time Through Week 48
Time Frame
Baseline, up to Week 48
Title
Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) Possibly or Probably Related to Treatment
Time Frame
up to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Westside Medical Associates of Los Angeles
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Desert Oasis Healthcare (Desert Medical Group, Inc.)
City
Palm Springs
State/Province
California
ZIP/Postal Code
92292
Country
United States
Facility Name
Preventive Cardiology Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Invesclinic U.S., LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Ocean Blue Medical Research Center Inc.
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
A Positive Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Y&L Advance Health care, Inc. D/B/A Elite Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
AppleMed Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
HeartWell LLP
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Alta Pharmaceutical Research Center
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Northwest Heart Clinical Research
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
The Research Group of Lexington, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Cardiology Associates Research, LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Glacier View Research Institute
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Methodist Physicians Clinic Heart Consultants
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Clinical Research of South Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
NYC Research, Inc.
City
Long Island City
State/Province
New York
ZIP/Postal Code
11106
Country
United States
Facility Name
Mid Hudson Medical Research, PLLC
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai (ISMMS)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Lucas Research, Inc
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
PriMed Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Advanced Medical Research, LLC
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
South Oklahoma Heart Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Tribe Clinical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
WR-CllinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
BFHC Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Linear Clinical Research
City
Perth
State/Province
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Core Research Group
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
University of the Sunshine Coast
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
LMC Diabetes & Endocrinology
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K 4M2
Country
Canada
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
LMC Manna Research - Bayview
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Centre d'Etudes Cliniques ECOGENE-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H5H6
Country
Canada
Facility Name
ViaCar Recherches Cliniques Inc.
City
Greenfield
State/Province
Quebec
ZIP/Postal Code
J4V2G8
Country
Canada
Facility Name
Institut de Recherches Cliniques de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W2T2
Country
Canada
Facility Name
Uniklinik RWTH
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
0 4103
Country
Germany
Facility Name
Lausmed Kft.
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Principal SMO Kft
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
DRC Gyogyszervizsgalo Kozpont Balatonfured
City
Balatonföldvár
ZIP/Postal Code
H-8230
Country
Hungary
Facility Name
Belgyogyaszati - Kardiologiai Maganrendelo
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pharma4trial Ltd
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Selye Janos Korhaz
City
Komárom
ZIP/Postal Code
2921
Country
Hungary
Facility Name
Borbanya Praxis Kft.
City
Nyiregyhaza
ZIP/Postal Code
4405
Country
Hungary
Facility Name
Medifarma-98 Kft.
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Uni Van Amsterdam Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
D&A Research
City
Sneek
ZIP/Postal Code
08601
Country
Netherlands
Facility Name
Auckland Clinical Studies
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Lipid and Diabetes Research Group
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Lakeland Clinical Trials - Waikato
City
Hamilton
ZIP/Postal Code
3200
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Lakeland Clinical Trials - Rotorua
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
Spolka Lekarzy Intercor Sp.z.o.o.
City
Bydgoszcz
ZIP/Postal Code
85-605
Country
Poland
Facility Name
NZOZ TWOJE ZDROWIE EL Sp.z.o.o.
City
Elbląg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek.
City
Gdynia
ZIP/Postal Code
81-157
Country
Poland
Facility Name
Zaklad Opieki Zdrowotnej Leczyca
City
Leczyca
ZIP/Postal Code
99-100
Country
Poland
Facility Name
Medicome Sp. z.o.o.
City
Oświęcim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Praktyka Lekarska Ewa Krzyzagorska
City
Poznań
ZIP/Postal Code
61-655
Country
Poland
Facility Name
KO-MED M Konieczny Cent. Wielosp. Opieki
City
Puławy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Centrum Medyczne K2J2
City
Wołomin
ZIP/Postal Code
05-200
Country
Poland
Facility Name
All-MED Centrum Medyczne
City
Łódź
ZIP/Postal Code
94-048
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia

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