Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06822790

PHASE3

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Sponsor: Arrowhead Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133). Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of \<=10% within 30 days prior to Day 1. Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria: 1. HbA1c ≤10% within 30 days prior to Day 1 2. Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d) 3. Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001 4. Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001 All eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.

Official title: A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (SHASTA-10 Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

869

Start Date

2025-04-09

Completion Date

2028-07

Last Updated

2026-03-23

Healthy Volunteers

Conditions

Hypertriglyceridemia

Interventions

DRUG

Plozasiran Injection

ARO-APOC3 injection

Inclusion Criteria: * Adult males, or nonpregnant (who do not plan to become pregnant), nonlactating adult females, who are able and willing to provide written informed consent prior to the performance of any study-specific procedures * Completed all required study visits per protocol in the parent study * Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 90 days after the End of Study (EOS) or the last dose of plozasiran, whichever is later. Male subjects must agree to use a condom during the study and for at least 90 days after the EOS or last dose of plozasiran whichever is later. Subjects must not donate sperm or eggs during the study and for at least 90 days after the EOS or last dose of plozasiran, whichever is later. Female subjects of childbearing potential on hormonal contraceptives must be stable on medication for \>1 menstrual cycle prior to Day 1. * Subjects 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 to a previous adverse reaction associated with, attributed to, or caused by specific drug) * If the subject has a medical history of clinical atherosclerotic cardiovascular disease (ASCVD) or elevated 10-year ASCVD risk (eg, ≥7.5% per American Heart Association/American College of Cardiology \[AHA/ACC\] risk calculator for subjects ≥40 years of age or Framingham risk score calculator for subjects under the age of 40), the subject must be on appropriate lipid-lowering therapy as per local standard of care (ie, including moderate-to-high intensity statin, as indicated). If the subject has diabetes: 1. Subject must be on optimized antidiabetic regimen as defined by the local standards, Investigator, and institutional practices 2. Subject must have no events of diabetic ketoacidosis, diabetic decompensation/ hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks of the Day 1 visit - Willing to follow diet counseling and maintain a stable low-fat diet Subjects in the USA and Canada who completed protocol AROAPOC3-2003 meeting all eligibility criteria (with the exception of inclusion criteria #9 which is not applicable to these subjects) who also meet the following additional criteria may enroll in this trial: * HbA1c ≤10% within 30 days prior to Day 1 * Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND either (c) or (d) below: * Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001 * Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001 * Subjects who previously met all eligibility requirements for AROAPOC3-3003, or AROAPOC3-3004 and were not permitted to proceed to randomization per Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. These subjects must meet all eligibility criteria prior to enrollment (with the exception of inclusion criteria #2 and #8 which are not applicable to these subjects) and have an HbA1c ≤10% within 30 days of Day 1. Exclusion Criteria: * Subject was permanently discontinued from receiving plozasiran in the parent study due to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or due to HbA1c elevation that did not respond to antidiabetic regimen * Subject withdrew consent for continued study treatment in the parent study * Known hypersensitivity to the active substance or to any of the excipients of plozasiran * Known hypersensitivity to the active substance or to any of the excipients of plozasiran * Any new condition or worsening of existing condition or any other situation that in the Investigator's judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements, or put the subject at an additional safety risk * Unwilling to limit alcohol consumption to within moderate limits for the duration of the study. * Poorly controlled glycemia (ie, HbA1c \>10%) based upon the most recent HbA1c level reported in the parent trial prior to Day 1 * Acute pancreatitis within 4 weeks prior to Day 1 * Use of any hepatocyte-targeted siRNA that targets lipids and/or triglycerides within 365 days before Day 1 (except plozasiran or inclisiran, which are permitted). Administration of inclisiran must be separated from administration of plozasiran by at least 4 weeks throughout the treatment period * 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 PK, whichever is longer. * Use of an investigational agent (other than plozasiran) or device within 30 days or within 5 half-lives, based on plasma PK, whichever is longer, prior to Day 1 (V1) or current participation in an interventional investigational study. * Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days prior to Day 1. Individuals with stable well-controlled atrial arrhythmias will be allowed to participate in the study. * Uncontrolled hypertension (ie, seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg) at Day 1; subject may be re-evaluated when hypertension is controlled. Note: Other inclusion/exclusion criteria may apply per protocol

Locations (170)

Research Site 21

Bakersfield, California, United States

Research Site 9

Beverly Hills, California, United States

Research Site 11

Canoga Park, California, United States

Research Site 40

Garden Grove, California, United States

Research Site 39

Lincoln, California, United States

Research Site 34

Oxnard, California, United States

Research Site 155

Fort Lauderdale, Florida, United States

Research Site 14

Hialeah, Florida, United States

Research Site 154

Miami, Florida, United States

Research Site 1

Miami Lakes, Florida, United States

Research Site 162

Mt. Dora, Florida, United States

Research Site 42

Mt. Dora, Florida, United States

Research Site 38

North Miami, Florida, United States

Research Site 159

Orlando, Florida, United States

Research Site 41

Orlando, Florida, United States

Research Site 16

Tamarac, Florida, United States

Research Site 18

Tampa, Florida, United States

Research Site 17

Park Ridge, Illinois, United States

Research Site 167

Elkhart, Indiana, United States

Research Site 43

Elkhart, Indiana, United States

Research Site 157

Indianapolis, Indiana, United States

Research Site 28

Overland Park, Kansas, United States

Research Site 23

Topeka, Kansas, United States

Research Site 12

Annapolis, Maryland, United States

Research Site 166

Baltimore, Maryland, United States

Research Site 44

Baltimore, Maryland, United States

Research Site 30

Flint, Michigan, United States

Research Site 33

Jackson, Mississippi, United States

Research Site 32

Olive Branch, Mississippi, United States

Research Site 2

Jefferson City, Missouri, United States

Research Site 29

Fremont, Nebraska, United States

Research Site 3

Omaha, Nebraska, United States

Research Site 165

Summit, New Jersey, United States

Research Site 77

Summit, New Jersey, United States

Research Site 156

Long Island City, New York, United States

Research Site 72

Long Island City, New York, United States

Research Site 37

Asheboro, North Carolina, United States

Research Site 36

Morehead City, North Carolina, United States

Research Site 169

Wilmington, North Carolina, United States

Research Site 22

Beavercreek, Ohio, United States

Research Site 164

Norman, Oklahoma, United States

Research Site 76

Norman, Oklahoma, United States

Research Site 31

Oklahoma City, Oklahoma, United States

Research Site 26

Horsham, Pennsylvania, United States

Research Site 8

Newport, Pennsylvania, United States

Research Site 27

El Paso, Texas, United States

Research Site 160

Fort Worth, Texas, United States

Research Site 158

Houston, Texas, United States

Research Site 73

Houston, Texas, United States

Research Site 163

Houston, Texas, United States

Research Site 75

Houston, Texas, United States

Research Site 24

Houston, Texas, United States

Research Site 161

Plano, Texas, United States

Research Site 74

Plano, Texas, United States

Research Site 168

San Antonio, Texas, United States

Research Site 13

Sugar Land, Texas, United States

Research Site 170

Tomball, Texas, United States

Research Site 25

Victoria, Texas, United States

Research Site 15

Bountiful, Utah, United States

Research Site 35

St. George, Utah, United States

Research Site 10

Manassas, Virginia, United States

Research Site 86

Box Hill, Victoria, Australia

Research Site 48

Gozée, Belgium

Research Site 91

Gozée, Belgium

Research Site 87

Hasselt, Belgium

Research Site 47

Mechelen, Belgium

Research Site 90

Mechelen, Belgium

Research Site 46

Namur, Belgium

Research Site 89

Namur, Belgium

Research Site 45

Wetteren, Belgium

Research Site 88

Wetteren, Belgium

Research Site 100

Dimitrovgrad, Bulgaria

Research Site 54

Kardzhali, Bulgaria

Research Site 98

Kardzhali, Bulgaria

Research Site 52

Kyustendil, Bulgaria

Research Site 96

Kyustendil, Bulgaria

Research Site 49

Pleven, Bulgaria

Research Site 92

Pleven, Bulgaria

Research Site 50

Plovdiv, Bulgaria

Research Site 93

Plovdiv, Bulgaria

Research Site 94

Rousse, Bulgaria

Research Site 53

Sofia, Bulgaria

Research Site 51

Sofia, Bulgaria

Research Site 95

Sofia, Bulgaria

Research Site 97

Sofia, Bulgaria

Research Site 99

Stara Zagora, Bulgaria

Research Site 20

Victoria, British Columbia, Canada

Research Site 103

Halifax, Nova Scotia, Canada

Research Site 7

London, Ontario, Canada

Research Site 101

Sarnia, Ontario, Canada

Research Site 55

Sarnia, Ontario, Canada

Research Site 102

Waterloo, Ontario, Canada

Research Site 6

Chicoutimi, Quebec, Canada

Research Site 5

Montreal, Quebec, Canada

Research Site 19

Québec, Quebec, Canada

Research Site 4

Québec, Quebec, Canada

Research Site 56

Kitchener, Canada

Research Site 104

Beijing, Beijing Municipality, China

Research Site 57

Beijing, Beijing Municipality, China

Research Site 62

Guangzhou, Guangdong, China

Research Site 112

Guangzhou, Guangdong, China

Research Site 111

Guangzhou, Guangdong, China

Research Site 114

Liuchow, Guangxi Zhuang, China

Research Site 63

Liuchow, Guangxi Zhuang, China

Research Site 106

Xingtai, Hebei, China

Research Site 107

Changsha, Hu'Nan, China

Research Site 59

Changsha, Hu'Nan, China

Research Site 108

Changsha, Hu'Nan, China

Research Site 115

Baotou, Inner Mongolia, China

Research Site 64

Baotou, Inner Mongolia, China

Research Site 110

Nanchang, Jiangxi, China

Research Site 61

Nanchang, Jiangxi, China

Research Site 105

Yuncheng, Shanxi, China

Research Site 58

Yuncheng, Shanxi, China

Research Site 113

Chengdu, Sichuan, China

Research Site 109

Wenzhou, Zhejiang, China

Research Site 60

Wenzhou, Zhejiang, China

Research Site 117

Hodonín, Czechia

Research Site 65

Hodonín, Czechia

Research Site 118

Olomouc, Czechia

Research Site 119

Prague, Czechia

Research Site 66

Prague, Czechia

Research Site 116

Praha 4-Krc, Czechia

Research Site 120

Pessac, Gironde, France

Research Site 123

Budapest, Hungary

Research Site 122

Budapest, Hungary

Research Site 68

Budapest, Hungary

Research Site 121

Pécs, Hungary

Research Site 67

Pécs, Hungary

Research Site 124

Daugavpils, Latvia

Research Site 125

Riga, Latvia

Research Site 69

Riga, Latvia

Research Site 126

Kaunas, Lithuania

Research Site 70

Kaunas, Lithuania

Research Site 127

Šiauliai, Lithuania

Research Site 128

Christchurch, New Zealand

Research Site 129

Wellington, New Zealand

Research Site 130

Elblag, Poland

Research Site 78

Elblag, Poland

Research Site 134

Katowice, Poland

Research Site 81

Katowice, Poland

Research Site 141

Katowice, Poland

Research Site 85

Katowice, Poland

Research Site 138

Krakow, Poland

Research Site 83

Krakow, Poland

Research Site 136

Lodz, Poland

Research Site 131

Lodz, Poland

Research Site 79

Lodz, Poland

Research Site 132

Malbork, Poland

Research Site 80

Malbork, Poland

Research Site 135

Szczecin, Poland

Research Site 139

Warsaw, Poland

Research Site 84

Warsaw, Poland

Research Site 133

Wroclaw, Poland

Research Site 140

Wroclaw, Poland

Research Site 137

Żarów, Poland

Research Site 82

Żarów, Poland

Research Site 142

Bucharest, Romania

Research Site 143

Ploieşti, Romania

Research Site 144

Târgu Mureş, Romania

Research Site 145

Timișoara, Romania

Research Site 147

Bardejov, Slovakia

Research Site 146

Košice, Slovakia

Research Site 148

Rožňava, Slovakia

Research Site 149

Somerset West, Western Cape, South Africa

Research Site 150

Seville, Sevilla, Spain

Research Site 151

Zaragoza, Zaragoza, Spain

Research Site 152

Plymouth, Devon, United Kingdom

Research Site 71

Plymouth, Devon, United Kingdom

Research Site 153

Torquay, Devon, United Kingdom

Clinical Research Directory

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (170)