Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Purpose
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). 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.
Condition
- Hypertriglyceridemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L) - Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 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% - Willing to follow diet counseling and maintain a stable low-fat diet - 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 - Acute pancreatitis within 4 weeks prior to screening - Body mass index >45 kg/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 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
Garden Grove, California 92844
Garden Grove, California 92844
National Institute of Clinical Research, Inc.
Huntington Beach, California 92648
Huntington Beach, California 92648
Orange County Research Center, Inc.
Lake Forest, California 92630
Lake Forest, California 92630
Clinical Trials Research
Lincoln, California 95648
Lincoln, California 95648
VA Long Beach Healthcare System
Long Beach, California 90822
Long Beach, California 90822
Catalina Research Institute, LLC
Montclair, California 91763
Montclair, California 91763
Fomat Medical Research, Inc.
Oxnard, California 93030
Oxnard, California 93030
Velocity Clinical Research, Panorama City
Panorama City, California 91402
Panorama City, California 91402
The Cardiovascular Center
Redding, California 96001
Redding, California 96001
Legacy Clinical Trials
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Innovative Research of West Florida, Inc.
Clearwater, Florida 33756
Clearwater, Florida 33756
Neoclinical Research
Hialeah, Florida 33016
Hialeah, Florida 33016
East Coast Institute for Research, LLC
Lake City, Florida 32055
Lake City, Florida 32055
Panax Clinical Research
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
Adult Medicine of Lake County
Mount Dora, Florida 32757
Mount Dora, Florida 32757
Harmony Clinical Research, Inc.
North Miami, Florida 33162
North Miami, Florida 33162
Florida Institute for Clinical Research
Orlando, Florida 32825
Orlando, Florida 32825
Baptist Hospital Cardiology
Pensacola, Florida 32503
Pensacola, Florida 32503
Cardiovascular Center of Sarasota Foundation for Research and Education
Sarasota, Florida 34239
Sarasota, Florida 34239
TBC Research
Tamarac, Florida 33321
Tamarac, Florida 33321
Georgia Clinical Research Center, Inc.
Lawrenceville, Georgia 30044
Lawrenceville, Georgia 30044
East Coast Institute For Research, LLC
Macon, Georgia 31210
Macon, Georgia 31210
Meridian Clinical Research, LLC
Savannah, Georgia 31406
Savannah, Georgia 31406
RNA America Health Sciences
Sugar Hill, Georgia 30518
Sugar Hill, Georgia 30518
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Park Ridge, Illinois 60068
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 & 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
University of Louisville Research Foundation
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Southern Clinical Research
Metairie, Louisiana 70001
Metairie, Louisiana 70001
Annapolis Internal Medicine
Annapolis, Maryland 21401
Annapolis, Maryland 21401
Ascension Saint Agnes Heart Care
Baltimore, Maryland 21229
Baltimore, Maryland 21229
Elite Clinical Research Center
Flint, Michigan 48532
Flint, Michigan 48532
University of Minnesota Medical Center
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
Olive Branch Family Medical Center
Olive Branch, Mississippi 38654
Olive Branch, Mississippi 38654
Jefferson City Medical Group PC
Jefferson City, Missouri 65109
Jefferson City, Missouri 65109
St. Louis Heart and Vascular
Saint Louis, Missouri 63136
Saint Louis, Missouri 63136
Velocity Clinical Research
Norfolk, Nebraska 68701
Norfolk, Nebraska 68701
Methodist Physicians Clinic Heart Consultants
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Midwest Regional Health Services LLC
Omaha, Nebraska 68144
Omaha, Nebraska 68144
Santa Rosa Medical Centers of Nevada
Las Vegas, Nevada 89119
Las Vegas, Nevada 89119
Overlook Medical Center
Summit, New Jersey 07901
Summit, New Jersey 07901
Jack D Weike Hospital
Bronx, New York 10461
Bronx, New York 10461
CTSI Investigational Pharmacy
New York, New York 10016
New York, New York 10016
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
University of Rochester - PARENT
Rochester, New York 14642
Rochester, New York 14642
Velocity Clinical Research-Vestal New York
Vestal, New York 13850
Vestal, New York 13850
Triad Internal Medicine
Asheboro, North Carolina 27203
Asheboro, North Carolina 27203
Carteret Medical Group
Morehead City, North Carolina 28557
Morehead City, North Carolina 28557
Wake Forest University Health Sciences, Department of Cardiology
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Internal Medicine Care Inc
Beavercreek, Ohio 45431
Beavercreek, Ohio 45431
University of Cincinnati College of Medicine
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Columbus, Ohio 43210
OhioHealth Research Institute
Columbus, Ohio 43214
Columbus, Ohio 43214
Lynn Health Science Institute East
Oklahoma City, Oklahoma 73111
Oklahoma City, Oklahoma 73111
Lynn Health Sci. Inst.
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
Abington Medical Specialists, P.C.
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
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Piedmont Research Partners
Fort Mill, South Carolina 29707
Fort Mill, South Carolina 29707
Tribe Clinical Research, LLC
Greenville, South Carolina 29607
Greenville, South Carolina 29607
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee 37411
Chattanooga, Tennessee 37411
Cardiovascular Research Center of Knoxville
Powell, Tennessee 37849
Powell, Tennessee 37849
David Turbay, MD, PLLC
El Paso, Texas 79905
El Paso, Texas 79905
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas 76132
Fort Worth, Texas 76132
Gonzalez Research Institute
Houston, Texas 77029
Houston, Texas 77029
Baylor College of Medicine
Houston, Texas 77030
Houston, Texas 77030
Houston Methodist Hospital
Houston, Texas 77030
Houston, Texas 77030
Juno Research LLC
Houston, Texas 77040
Houston, Texas 77040
Clinical Trial Network LLC
Houston, Texas 77074
Houston, Texas 77074
PlanIt Research, PLLC
Houston, Texas 77079
Houston, Texas 77079
Synergy Groups Medical LLC
Houston, Texas 77087
Houston, Texas 77087
Spring Clinical Research
Houston, Texas 77090
Houston, Texas 77090
Endocrine and Psychiatry Center
Houston, Texas 77095
Houston, Texas 77095
Synergy Groups Medical
Missouri City, Texas 77459
Missouri City, Texas 77459
Stryde Research
Plano, Texas 75093
Plano, Texas 75093
Sugar Lakes Family Practice
Sugar Land, Texas 77479
Sugar Land, Texas 77479
Northwest Houston Heart Center
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, LLC
Saint George, Utah 84790
Saint George, Utah 84790
Manassas Clinical Research Center
Manassas, Virginia 20110
Manassas, Virginia 20110
UW Medicine Diabetes Institute Clinical Research Unit
Seattle, Washington 98109
Seattle, Washington 98109
More Details
- NCT ID
- NCT06347133
- Status
- Recruiting
- Sponsor
- Arrowhead Pharmaceuticals