Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

NCT ID: NCT06347133

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2026-09-30

Brief Summary

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.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Plozasiran Injection

4 doses of plozasiran by subcutaneous (sc) injection

Group Type: EXPERIMENTAL

Plozasiran Injection

Intervention Type: DRUG

ARO-APOC3 Injection

Placebo

calculated volume to match active treatment by sc injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

sterile normal saline (0.9% NaCl)

Interventions

Plozasiran Injection

ARO-APOC3 Injection

Intervention Type: DRUG

Placebo

sterile normal saline (0.9% NaCl)

Intervention Type: DRUG

Other Intervention Names

ARO-APOC3

Eligibility Criteria

Inclusion Criteria

• Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
• 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 ≤9.0%
• Willing to follow diet counseling and maintain a stable low-fat diet
• Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arrowhead Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site 1

Birmingham, Alabama, United States

Research Site 2

Mobile, Alabama, United States

Research Site 3

Beverly Hills, California, United States

Research Site 4

Canoga Park, California, United States

Research Site 5

Garden Grove, California, United States

Research Site 6

Huntington Beach, California, United States

Research Site 7

Lake Forest, California, United States

Research Site 8

Lincoln, California, United States

Research Site 9

Long Beach, California, United States

Research Site 10

Montclair, California, United States

Research Site 11

Oxnard, California, United States

Research Site 12

Redding, California, United States

Research Site 13

Van Nuys, California, United States

Research Site 14

Colorado Springs, Colorado, United States

Research Site 15

Clearwater, Florida, United States

Research Site 16

Hialeah, Florida, United States

Research Site 17

Lake City, Florida, United States

Research Site 18

Miami Lakes, Florida, United States

Research Site 19

Mt. Dora, Florida, United States

Research Site 20

North Miami Beach, Florida, United States

Research Site 21

Orlando, Florida, United States

Research Site 22

Pensacola, Florida, United States

Research Site 23

Sarasota, Florida, United States

Research Site 24

Tamarac, Florida, United States

Research Site 25

Lawrenceville, Georgia, United States

Research Site 26

Macon, Georgia, United States

Research Site 27

Savannah, Georgia, United States

Research Site 28

Sugar Hill, Georgia, United States

Research Site 29

Park Ridge, Illinois, United States

Research Site 30

Elkhart, Indiana, United States

Research Site 31

Indianapolis, Indiana, United States

Research Site 32

South Bend, Indiana, United States

Research Site 33

Overland Park, Kansas, United States

Research Site 34

Topeka, Kansas, United States

Research Site 35

Louisville, Kentucky, United States

Research Site 36

Zachary, Louisiana, United States

Research Site 37

Annapolis, Maryland, United States

Research Site 38

Baltimore, Maryland, United States

Research Site 39

Flint, Michigan, United States

Research Site 40

Minneapolis, Minnesota, United States

Research Site 41

Olive Branch, Mississippi, United States

Research Site 42

Jefferson City, Missouri, United States

Research Site 43

St Louis, Missouri, United States

Research Site 44

Norfolk, Nebraska, United States

Research Site 46

Omaha, Nebraska, United States

Research Site 45

Omaha, Nebraska, United States

Research Site 47

Las Vegas, Nevada, United States

Research Site 48

Summit, New Jersey, United States

Research Site 52

New York, New York, United States

Research Site 51

New York, New York, United States

Research Site 53

Riverhead, New York, United States

Research Site 54

Rochester, New York, United States

Research Site 49

The Bronx, New York, United States

Research Site 50

The Bronx, New York, United States

Research Site 55

Vestal, New York, United States

Research Site 56

Asheboro, North Carolina, United States

Research Site 57

Morehead City, North Carolina, United States

Research Site 58

Wilmington, North Carolina, United States

Research Site 59

Winston-Salem, North Carolina, United States

Research Site 60

Beavercreek, Ohio, United States

Research Site 61

Cincinnati, Ohio, United States

Research Site 63

Columbus, Ohio, United States

Research Site 62

Columbus, Ohio, United States

Research Site 64

Norman, Oklahoma, United States

Research Site 66

Oklahoma City, Oklahoma, United States

Research Site 65

Oklahoma City, Oklahoma, United States

Research Site 67

Horsham, Pennsylvania, United States

Research Site 68

Newport, Pennsylvania, United States

Research Site 69

Newport, Pennsylvania, United States

Research Site 70

Philadelphia, Pennsylvania, United States

Research Site 71

Wilkes-Barre, Pennsylvania, United States

Research Site 72

Fort Mill, South Carolina, United States

Research Site 73

Greenville, South Carolina, United States

Research Site 74

Chattanooga, Tennessee, United States

Research Site 75

Powell, Tennessee, United States

Research Site 76

El Paso, Texas, United States

Research Site 77

Fort Worth, Texas, United States

Research Site 86

Houston, Texas, United States

Research Site 84

Houston, Texas, United States

Research Site 85

Houston, Texas, United States

Research Site 78

Houston, Texas, United States

Research Site 80

Houston, Texas, United States

Research Site 83

Houston, Texas, United States

Research Site 82

Houston, Texas, United States

Research Site 79

Houston, Texas, United States

Research Site 81

Houston, Texas, United States

Research Site 87

Laredo, Texas, United States

Research Site 88

Missouri City, Texas, United States

Research Site 89

Plano, Texas, United States

Research Site 90

San Antonio, Texas, United States

Research Site 91

Sugar Land, Texas, United States

Research Site 92

Tomball, Texas, United States

Research Site 93

Victoria, Texas, United States

Research Site 94

Bountiful, Utah, United States

Research Site 95

St. George, Utah, United States

Research Site 96

Manassas, Virginia, United States

Research Site 97

Seattle, Washington, United States

Research Site 102

CABA, Buenos Aires, Argentina

Research Site 100

CABA, Buenos Aires, Argentina

Research Site 103

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Research Site 104

Córdoba, Córdoba Province, Argentina

Research Site 98

Córdoba, Córdoba Province, Argentina

Research Site 101

Godoy Cruz, Mendoza Province, Argentina

Research Site 105

Rosario, Santa Fe Province, Argentina

Research Site 99

Rosario, Santa Fe Province, Argentina

Research Site 106

Córdoba, , Argentina

Research Site 107

Blacktown, New South Wales, Australia

Research Site 108

Merewether, New South Wales, Australia

Research Site 110

Clayton, Victoria, Australia

Research Site 109

Heidelberg Heights, Victoria, Australia

Research Site 111

Blagoevgrad, , Bulgaria

Research Site 112

Burgas, , Bulgaria

Research Site 113

Byala, , Bulgaria

Research Site 114

Dimitrovgrad, , Bulgaria

Research Site 115

Haskovo, , Bulgaria

Research Site 116

Kyustendil, , Bulgaria

Research Site 117

Pleven, , Bulgaria

Research Site 118

Pleven, , Bulgaria

Research Site 120

Plovdiv, , Bulgaria

Research Site 119

Plovdiv, , Bulgaria

Research Site 121

Plovdiv, , Bulgaria

Research Site 122

Rousse, , Bulgaria

Research Site 123

Sevlievo, , Bulgaria

Research Site 137

Sofia, , Bulgaria

Research Site 133

Sofia, , Bulgaria

Research Site 126

Sofia, , Bulgaria

Research Site 129

Sofia, , Bulgaria

Research Site 132

Sofia, , Bulgaria

Research Site 130

Sofia, , Bulgaria

Research Site 131

Sofia, , Bulgaria

Research Site 135

Sofia, , Bulgaria

Research Site 124

Sofia, , Bulgaria

Research Site 125

Sofia, , Bulgaria

Research Site 127

Sofia, , Bulgaria

Research Site 134

Sofia, , Bulgaria

Research Site 128

Sofia, , Bulgaria

Research Site 136

Stara Zagora, , Bulgaria

Research Site 140

North Vancouver, British Columbia, Canada

Research Site 141

Victoria, British Columbia, Canada

Research Site 142

Brampton, Ontario, Canada

Research Site 143

Sarnia, Ontario, Canada

Research Site 144

Waterloo, Ontario, Canada

Research Site 145

Chicoutimi, Quebec, Canada

Research Site 146

Laval, Quebec, Canada

Research Site 149

Montreal, Quebec, Canada

Research Site 139

Québec, Quebec, Canada

Research Site 147

Québec, Quebec, Canada

Research Site 148

Québec, Quebec, Canada

Research Site 138

Halifax, , Canada

Research Site 151

Prague, Prague, Czechia

Research Site 157

Brno, , Czechia

Research Site 154

Hodonín, , Czechia

Research Site 159

Hradec Králové, , Czechia

Research Site 160

Náchod, , Czechia

Research Site 162

Olomouc, , Czechia

Research Site 155

Ostrava, , Czechia

Research Site 152

Prague, , Czechia

Research Site 156

Praha 4-Krc, , Czechia

Research Site 150

Slaný, , Czechia

Research Site 163

Teplice, , Czechia

Research Site 158

Trutnov, , Czechia

Research Site 161

Uherské Hradiště, , Czechia

Research Site 153

Ústí nad Labem, , Czechia

Research Site 164

Marseille, Bouches du Rhone, France

Research Site 167

Pessac, Gironde, France

Research Site 166

Lyon, Rhone, France

Research Site165

Paris, , France

Research Site 170

Deggingen, Baden-Wurttemberg, Germany

Research Site 169

Wallerfing, Bavaria, Germany

Research Site 168

Magdeburg, Saxony-Anhalt, Germany

Research Site 171

Békéscsaba, , Hungary

Research Site 175

Budapest, , Hungary

Research Site 183

Budapest, , Hungary

Research Site 179

Budapest, , Hungary

Research Site 184

Budapest, , Hungary

Research Site 180

Budapest, , Hungary

Research Site 182

Kaposvár, , Hungary

Research Site 176

Miskolc, , Hungary

Research Site 172

Pécs, , Hungary

Research Site 177

Pécs, , Hungary

Research Site 178

Szeged, , Hungary

Research Site 173

Veszprém, , Hungary

Research Site 174

Zalaegerszeg, , Hungary

Research Site 186

Rozzano, Milano, Italy

Research Site 187

Palermo, Sicily, Italy

Research Site 189

Bologna, , Italy

Research Site 185

Brescia, , Italy

Research Site 188

Milan, , Italy

Research Site 200

Bydgoszcz, , Poland

Research Site 202

Bydgoszcz, , Poland

Research Site 192

Elblag, , Poland

Research Site 193

Gdynia, , Poland

Research Site 190

Katowice, , Poland

Research Site 197

Krakow, , Poland

Research Site 204

Krakow, , Poland

Research Site 201

Lodz, , Poland

Research Site 191

Lodz, , Poland

Research Site 194

Malbork, , Poland

Research Site 199

Szczecin, , Poland

Research Site 207

Torun, , Poland

Research Site 205

Warsaw, , Poland

Research Site 198

Warsaw, , Poland

Research Site 196

Wroclaw, , Poland

Research Site 208

Wroclaw, , Poland

Research Site 206

Wroclaw, , Poland

Research Site 195

Zamość, , Poland

Research Site 203

Żarów, , Poland

Research Site 214

Banská Bystrica, , Slovakia

Research Site 212

Bardejov, , Slovakia

Research Site 217

Bratislava, , Slovakia

Research Site 216

Bratislava, , Slovakia

Research Site 210

Košice, , Slovakia

Research Site 213

Moldava nad Bodvou, , Slovakia

Research Site 209

Nové Zámky, , Slovakia

Research Site 211

Prešov, , Slovakia

Research Site 215

Rožňava, , Slovakia

Research Site 218

Žilina, , Slovakia

Research Site 221

Centurion, Gauteng, South Africa

Research Site 222

Krugersdorp, Gauteng, South Africa

Research Site 228

Pretoria, Gauteng, South Africa

Research Site 224

Durban, KwaZulu-Natal, South Africa

Research Site 227

Cape Town, Western Cape, South Africa

Research Site 219

Cape Town, Western Cape, South Africa

Research Site 223

Cape Town, Western Cape, South Africa

Research Site 225

Cape Town, Western Cape, South Africa

Research Site 220

Somerset West, Western Cape, South Africa

Research Site 226

Pretoria, , South Africa

Research Site 234

Barcelona, Barcelona, Spain

Research Site 229

A Coruña, La Coruña, Spain

Research Site 230

Barcelona, , Spain

Research Site 232

Madrid, , Spain

Research Site 231

Valencia, , Spain

Research Site 233

Zaragoza, , Spain

Research Site 236

Plymouth, Devon, United Kingdom

Research Site 235

London, , United Kingdom

Countries

United States; Argentina; Australia; Bulgaria; Canada; Czechia; France; Germany; Hungary; Italy; Poland; Slovakia; South Africa; Spain; United Kingdom

Other Identifiers

2023-509302-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AROAPOC3-3009

Identifier Type: -

Identifier Source: org_study_id