Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Purpose
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.
Condition
- Severe Hypertriglyceridemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥500 mg/dL (≥5.65 mmol/L) - Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period - Fasting low density lipoprotein-cholesterol (LDL-C) ≤130 mg/dL (≤3.37 mmol/L) at screening - Screening HbA1C ≤8.5% - Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator)
Exclusion Criteria
- Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks - Use of any other hepatocyte-targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer (except inclisiran, which is permitted) - Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1- causing genes - Body mass index >45kg/m^2 Note: Additional Inclusion/Exclusion criteria may apply per protocol
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Plozasiran Injection |
4 doses of plozasiran (ARO-APOC3) by subcutaneous (sc) injection |
|
|
Placebo Comparator Placebo |
calculated volume to match active treatment by sc injection |
|
Recruiting Locations
Ascension St. Vincents Birmingham
Birmingham, Alabama 35205
Birmingham, Alabama 35205
IMC-Diagnostic and Medical Clinic LLC
Mobile, Alabama 36604
Mobile, Alabama 36604
National Heart Institute
Beverly Hills, California 90211
Beverly Hills, California 90211
Hope Clinical Research
Canoga Park, California 91303
Canoga Park, California 91303
National Institute of Clinical Research, Inc.
Huntington Beach, California 92648
Huntington Beach, California 92648
Clinical Trials Research
Lincoln, California 95648
Lincoln, California 95648
VA Long Beach Healthcare System
Long Beach, California 90822
Long Beach, California 90822
FOMAT Medical Research
Oxnard, California 93030
Oxnard, California 93030
Innovative Research of West Florida, Inc.
Clearwater, Florida 33756
Clearwater, Florida 33756
Harmony Clinical Research
North Miami, Florida 33162
North Miami, Florida 33162
Cardiovascular Center of Sarasota Foundation for Research and Education
Sarasota, Florida 34239
Sarasota, Florida 34239
Georgia Clinical Research, LLC
Lawrenceville, Georgia 30044
Lawrenceville, Georgia 30044
RNA America Health Sciences
Sugar Hill, Georgia 30518
Sugar Hill, Georgia 30518
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana 46514
Elkhart, Indiana 46514
Ascension St. Vincent Heart Center
Indianapolis, Indiana 46290
Indianapolis, Indiana 46290
The South Bend Clinic LLC
South Bend, Indiana 46617
South Bend, Indiana 46617
Midwest Heart and Vascular Specialists
Overland Park, Kansas 66211
Overland Park, Kansas 66211
Cotton-O'Neil Clinical Research Center, Stormont-Vail West
Topeka, Kansas 66606
Topeka, Kansas 66606
Southern Clinical Research Associates
Metairie, Louisiana 70001
Metairie, Louisiana 70001
Annapolis Internal Medicine
Annapolis, Maryland 21401
Annapolis, Maryland 21401
Contact:
Titus Abraham
410-897-9841
Titus Abraham
410-897-9841
Elite Clinical Research
Jackson, Mississippi 39202
Jackson, Mississippi 39202
Methodist Physicians Clinic
Fremont, Nebraska 68025
Fremont, Nebraska 68025
Velocity Clinical Research
Norfolk, Nebraska 68701
Norfolk, Nebraska 68701
Overlook Medical Center
Morristown, New Jersey 07960
Morristown, New Jersey 07960
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
Northwell Health Physician Partners at Peconic
Riverhead, New York 11901
Riverhead, New York 11901
Triad Internal Medicine
Asheboro, North Carolina 27203
Asheboro, North Carolina 27203
Wilmington Health
Wilmington, North Carolina 28412
Wilmington, North Carolina 28412
Internal Medicine Care Beavercreek
Beavercreek, Ohio 45431
Beavercreek, Ohio 45431
OhioHealth Riverside Methodist Hospital
Columbus, Ohio 43214
Columbus, Ohio 43214
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
AMS Cardiology
Horsham, Pennsylvania 19044
Horsham, Pennsylvania 19044
Capital Area Research, LLC
Newport, Pennsylvania 17074
Newport, Pennsylvania 17074
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Piedmont Research Partners
Fort Mill, South Carolina 29707
Fort Mill, South Carolina 29707
Tribe Clinical Research
Greenville, South Carolina 29607
Greenville, South Carolina 29607
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee 37411
Chattanooga, Tennessee 37411
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas 76132
Fort Worth, Texas 76132
Juno Research LLC
Houston, Texas 77040
Houston, Texas 77040
Care and Cure Clinic
Houston, Texas 77090
Houston, Texas 77090
Spring Clinical Research
Houston, Texas 77090
Houston, Texas 77090
Sugar Lakes Family Practice
Sugar Land, Texas 77479
Sugar Land, Texas 77479
Northwest Houston Clinical Research, PLLC
Tomball, Texas 77375
Tomball, Texas 77375
Crossroads Clinical Research
Victoria, Texas 77901
Victoria, Texas 77901
Cope Family Medicine
Bountiful, Utah 84010
Bountiful, Utah 84010
Chrysalis Clinical Research
Saint George, Utah 84790
Saint George, Utah 84790
Manassas Clinical Research Center
Manassas, Virginia 20110
Manassas, Virginia 20110
Roanoke Heart Institute
Roanoke, Virginia 24014
Roanoke, Virginia 24014
More Details
- NCT ID
- NCT06347016
- Status
- Recruiting
- Sponsor
- Arrowhead Pharmaceuticals