Severe HypertriglyceridemiaPhase 3SHASTA-4NCT06347016

Study of Plozasiran in Adults With Severe Hypertriglyceridemia

A Phase 3 study testing Plozasiran Injection in people with Severe Hypertriglyceridemia, run by Arrowhead Pharmaceuticals at 149 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Hypertriglyceridemia
What is being tested?: Plozasiran Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 311 participants
Where: 149 sitesin 16 countries
Study dates: 23 Jul 2024to 10 Sep 2026
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 ≤9.0%
Must be on standard of care lipid-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)

Who cannot join

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

Trial locations and contacts

149 sites in 16 countries.

Country

City, postcode or hospital

149 sites in 16 countries

United States50 sites

Research Site 20
Annapolis, Maryland, 21401
Research Site 28
Asheboro, North Carolina, 27203
Research Site 30
Beavercreek, Ohio, 45431
Research Site 3
Beverly Hills, California, 90211
Research Site 1
Birmingham, Alabama, 35205
Research Site 47
Bountiful, Utah, 84010
Research Site 4
Canoga Park, California, 91303
Research Site 39
Chattanooga, Tennessee, 37411
Research Site 9
Clearwater, Florida, 33756
Research Site 31
Columbus, Ohio, 43214
Research Site 14
Elkhart, Indiana, 46514
Research Site 37
Fort Mill, South Carolina, 29707
Research Site 40
Fort Worth, Texas, 76132
Research Site 22
Fremont, Nebraska, 68025
Research Site 38
Greenville, South Carolina, 29607
Research Site 33
Horsham, Pennsylvania, 19044
Research Site 41
Houston, Texas, 77040
Research Site 42
Houston, Texas, 77090
Research Site 43
Houston, Texas, 77090
Research Site 5
Huntington Beach, California, 92648
Research Site 15
Indianapolis, Indiana, 46290
Research Site 21
Jackson, Mississippi, 39202
Research Site 12
Lawrenceville, Georgia, 30044
Research Site 6
Lincoln, California, 95648
Research Site 7
Long Beach, California, 90822
Research Site 49
Manassas, Virginia, 20110
Research Site 19
Metairie, Louisiana, 70001
Research Site 2
Mobile, Alabama, 36604
Research Site 24
Morristown, New Jersey, 07960
Research Site 26
New York, New York, 10029
Research Site 34
Newport, Pennsylvania, 17074
Research Site 23
Norfolk, Nebraska, 68701
Research Site 10
North Miami, Florida, 33162
Research Site 32
Oklahoma City, Oklahoma, 73112
Research Site 17
Overland Park, Kansas, 66211
Research Site 8
Oxnard, California, 93030
Research Site 35
Philadelphia, Pennsylvania, 19104
Research Site 36
Philadelphia, Pennsylvania, 19104
Research Site 27
Riverhead, New York, 11901
Research Site 50
Roanoke, Virginia, 24014
Research Site 11
Sarasota, Florida, 34239
Research Site 16
South Bend, Indiana, 46617
Research Site 48
St. George, Utah, 84790
Research Site 13
Sugar Hill, Georgia, 30518
Research Site 44
Sugar Land, Texas, 77479
Research Site 25
The Bronx, New York, 10461
Research Site 45
Tomball, Texas, 77375
Research Site 18
Topeka, Kansas, 66606
Research Site 46
Victoria, Texas, 77901
Research Site 29
Wilmington, North Carolina, 28412

Other trials in United States

Bulgaria14 sites

Research Site 64
Byala, 7100
Research Site 65
Dimitrovgrad, 6400
Research Site 66
Haskovo, 6300
Research Site 67
Kyustendil, 2500
Research Site 68
Rousse, 7013
Research Site 69
Sevlievo, 5400
Research Site 76
Sofia, 1202
Research Site 70
Sofia, 1431
Research Site 73
Sofia, 1431
Research Site 71
Sofia, 1510
Research Site 75
Sofia, 1616
Research Site 72
Sofia, 1680
Research Site 74
Sofia, 1750
Research Site 77
Stara Zagora, 6003

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South Africa12 sites

Research Site 144
Cape Town, Western Cape, 7441
Research Site 139
Cape Town, Western Cape, 7500
Research Site 140
Cape Town, Western Cape, 7500
Research Site 143
Cape Town, Western Cape, 7530
Research Site 145
Cape Town, Western Cape, 7925
Research Site 135
Centurion, Gauteng, 0157
Research Site 138
Durban, KwaZulu-Natal, 4449
Research Site 136
Krugersdorp, Gauteng, 1739
Research Site 146
Mossel Bay, Western Cape, 6500
Research Site 142
Plettenberg Bay, Western Cape, 6600
Research Site 137
Pretoria, Gauteng, 0184
Research Site 141
Somerset West, Western Cape, 7570

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Poland9 sites

Research Site 122
Bydgoszcz, 85-065
Research Site 123
Gdynia, 81-338
Research Site 124
Katowice, 40-156
Research Site 129
Lodz, 94-255
Research Site 125
Malbork, 82-200
Research Site 126
Szczecin, 71-500
Research Site 130
Torun, 87-100
Research Site 127
Wroclaw, 51-314
Research Site 128
Zamość, 22-400

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Brazil8 sites

Research Site 62
Aracaju, Sergipe, 49055-530
Research Site 59
Belo Horizonte, Minas Gerais, 30150
Research Site 56
Brasília, Federal District, 70710
Research Site 57
Campinas, São Paulo, 13060
Research Site 63
Recife, 52051-380
Research Site 61
Salvador, Estado de Bahia, 40170
Research Site 58
Santo André, São Paulo, 09080
Research Site 60
São José do Rio Preto, São Paulo, 15090

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Latvia8 sites

Research Site 107
Daugavpils, LV-5410
Research Site 105
Daugavpils, LV-5417
Research Site 106
Daugavpils, LV-5417
Research Site 108
Kuldīga, LV-3301
Research Site 109
Riga, LV-1002
Research Site 110
Riga, LV-1038
Research Site 111
Riga, LV-1050
Research Site 112
Tukums, LV-3101

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Czechia7 sites

Research Site 83
Brno, 65691
Research Site 84
Náchod, 547 01
Research Site 85
Olomouc, 77900
Research Site 86
Prague, 100 00
Research Site 88
Slaný, 15006
Research Site 89
Teplice, 41501
Research Site 87
Trutnov, 541 01

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Hungary6 sites

Research Site 99
Békéscsaba, 5600
Research Site 100
Kaposvár, 7400
Research Site 101
Miskolc, 3530
Research Site 102
Pécs, 7623
Research Site 104
Pécs, 7635
Research Site 103
Zalaegerszeg, 8900

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Lithuania6 sites

Research Site 115
Kaunas, LT-48259
Research Site 113
Kaunas, LT-49387
Research Site 114
Kaunas, LT-50177
Research Site 118
Šiauliai, LT-76206
Research Site 116
Vilnius, LT-08406
Research Site 117
Vilnius, LT-08406

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Argentina5 sites

Research Site 52
CABA, Buenos Aires, 1128
Research Site 51
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1056ABJ
Research Site 54
Córdoba, Córdoba Province, 5003
Research Site 53
Godoy Cruz, Mendoza Province, 5501
Research Site 55
Rosario, Santa Fe Province, 2000

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Canada5 sites

Research Site 79
Chicoutimi, Quebec, G7H 7K9
Research Site 80
Laval, Quebec, H7T 2P5
Research Site 78
North Vancouver, British Columbia, V7M 2H4
Research Site 81
Québec, Quebec, G1G 3Y8
Research Site 82
Terrebonne, Quebec, J6V2H2

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France5 sites

Research Site 93
Bayonne, Pyrenees Atlantiques, 64100
Research Site 94
Lyon, Rhone, 69007
Research Site 91
Marseille, Bouches-du-Rhône, 13005
Research Site 90
Paris, 75013
Research Site 92
Pessac, Gironde, 33604

Other trials in France

Germany4 sites

Research Site 98
Berlin, 13353
Research Site 95
Deggingen, Baden-Wurttemberg, 73326
Research Site 97
Magdeburg, Saxony-Anhalt
Research Site 96
Wallerfing, Bavaria, 94574

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Slovakia4 sites

Research Site 134
Bratislava, 83101
Research Site 131
Nové Zámky, 94002
Research Site 132
Prešov, 08001
Research Site 133
Rožňava, 04801

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New Zealand3 sites

Research Site 119
Christchurch, 8011
Research Site 120
New Plymouth, 4310
Research Site 121
Newtown, 6021

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Spain3 sites

Research Site 149
A Coruña, La Coruña, 15006
Research Site 147
Madrid, 28041
Research Site 148
Seville, 41013

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About this study

Official title: Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozsiran in Adults With Severe Hypertriglyceridemia

Conditions: Severe Hypertriglyceridemia
Being tested: Plozasiran Injection, Placebo
Medical subject headings: Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Plozasiran InjectionDrug
Also called ARO-APOC3
ARO-APOC3 Injection
PlaceboDrug
sterile normal saline (0.9% NaCl)

Study groups in NCT06347016
Study group	Role	What they receive
Plozasiran Injection	Experimental	4 doses of plozasiran (ARO-APOC3) by subcutaneous (sc) injection Receives: Drug: Plozasiran Injection
Placebo	Placebo comparator	calculated volume to match active treatment by sc injection Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent change in fasting serum TG levels from baseline to Month 12 compared to placebo
Measured: Baseline, Month 12

Secondary outcomes (19)

Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
Measured: Baseline, Month 10
Proportion of subjects who achieve fasting TG levels of <500 mg/dL (<5.65 mmol/L) at Month 12 compared to placebo
Measured: Baseline, Month 12
Proportion of Subjects Who Achieve Fasting TG Levels of < 150 mg/dL (<1.69 mmol/L) at Month 12 compared to placebo
Measured: Baseline, Month 12
Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 compared to placebo
Measured: Baseline, Month 12
Percent change in non-HDL-C from baseline to Month 12 compared to placebo
Measured: Baseline, Month 12
Adjudicated AP Event Rate During the Treatment Period Compared to Placebo From Day 1 to Month 12
Measured: Month 12
Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo
Measured: From first dose of study drug through Month 12
Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment
Measured: From first dose of study drug through Month 12
Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment
Measured: From first dose of study drug through Month 12
Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment
Measured: From first dose of study drug through Month 12
Change from Baseline in Hemoglobin A1c (HbA1c) and Other Glycemic Control Parameters During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Change from Baseline in C-Peptide During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Initiation of New Medication for Hyperglycemia among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12
Measured: From first dose of study drug through Month 12
Titers of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12
Measured: From first dose of study drug through Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 202410 Sep 2026

First posted4 Apr 2024
Study start23 Jul 2024
Primary completion17 Jun 2026
Study completion10 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Severe HypertriglyceridemiaStudies of the same condition, open and under way.
More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 311 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06347016
Sponsor's protocol ID: AROAPOC3-3004
Other IDs: 2023-509301-80, 2023
Acronym: SHASTA-4
Status last verified: Oct 2026
First submitted: 29 Mar 2024
Last updated: 9 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Watts GF, Ballantyne CM, Blanco Echevarria A, Smith J, Rosenson RS, Subramanian S, Trippi J, Lepor N, Bajaj A, Blaha V, Scott R, Baass A, Goldberg IJ, Gallo A, Diaz JL, Saxena M, Li J, Zhou R, Aiyer L, Hellawell J, Hamilton J, Gaudet D; SHASTA-3 and SHASTA-4 Study Groups. Plozasiran for Severe Hypertriglyceridemia and Risk of Pancreatitis. N Engl J Med. 2026 Nov 5;395(18):1805-1817. doi: 10.1056/NEJMoa2610014.
PubMed 42981569

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia
Not yet recruitingPhase 2
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)
RecruitingPhase 3
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Severe Hypertriglyceridemia
RecruitingPhase 1
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
Cardiovascular, Metabolic Disease

All Severe Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozsiran in Adults With Severe Hypertriglyceridemia
ClinicalTrials.gov ID: NCT06347016
Acronym / sponsor ID: SHASTA-4 / AROAPOC3-3004
Conditions: Severe Hypertriglyceridemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 311 participants (actual)
Lead sponsor: Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 23 Jul 2024 (actual)
Primary completion: 17 Jun 2026 (actual)
Study completion: 10 Sep 2026 (actual)
First posted: 4 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Plozasiran Injection	Experimental	Drug: Plozasiran Injection4 doses of plozasiran (ARO-APOC3) by subcutaneous (sc) injection
Placebo	Placebo comparator	Drug: Placebocalculated volume to match active treatment by sc injection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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 ≤9.0%
Must be on standard of care lipid-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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Plozasiran InjectionAlso: ARO-APOC3ARO-APOC3 Injection	Drug	Plozasiran Injection
Placebosterile normal saline (0.9% NaCl)	Drug	Placebo

Primary outcome

Percent change in fasting serum TG levels from baseline to Month 12 compared to placebo
Time frame: Baseline, Month 12

19 secondary outcomes

Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
Time frame: Baseline, Month 10
Proportion of subjects who achieve fasting TG levels of <500 mg/dL (<5.65 mmol/L) at Month 12 compared to placebo
Time frame: Baseline, Month 12
Proportion of Subjects Who Achieve Fasting TG Levels of < 150 mg/dL (<1.69 mmol/L) at Month 12 compared to placebo
Time frame: Baseline, Month 12
Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 compared to placebo
Time frame: Baseline, Month 12
Percent change in non-HDL-C from baseline to Month 12 compared to placebo
Time frame: Baseline, Month 12
Adjudicated AP Event Rate During the Treatment Period Compared to Placebo From Day 1 to Month 12
Time frame: Month 12
Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo
Time frame: From first dose of study drug through Month 12
Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment
Time frame: From first dose of study drug through Month 12
Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment
Time frame: From first dose of study drug through Month 12
Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment
Time frame: From first dose of study drug through Month 12
Change from Baseline in Hemoglobin A1c (HbA1c) and Other Glycemic Control Parameters During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Change from Baseline in C-Peptide During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Initiation of New Medication for Hyperglycemia among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12
Time frame: From first dose of study drug through Month 12
Titers of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12
Time frame: From first dose of study drug through Month 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
Derived from this study: PubMed 42981569Watts GF, Ballantyne CM, Blanco Echevarria A, Smith J, Rosenson RS, Subramanian S, Trippi J, Lepor N, Bajaj A, Blaha V, Scott R, Baass A, Goldberg IJ, Gallo A, Diaz JL, Saxena M, Li J, Zhou R, Aiyer L, Hellawell J, Hamilton J, Gaudet D; SHASTA-3 and SHASTA-4 Study Groups. Plozasiran for Severe Hypertriglyceridemia and Risk of Pancreatitis. N Engl J Med. 2026 Nov 5;395(18):1805-1817. doi: 10.1056/NEJMoa2610014.
Individual participant dataSharing planned: Undecided

Related trials for Severe Hypertriglyceridemia

RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia
Not yet recruitingPhase 2
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)
RecruitingPhase 3
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Severe Hypertriglyceridemia
RecruitingPhase 1
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
Cardiovascular, Metabolic Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

149 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Plozasiran Injection in people with Severe Hypertriglyceridemia, run by Arrowhead Pharmaceuticals at 149 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States, Bulgaria, South Africa, Poland, Brazil and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in fasting serum TG levels from baseline to Month 12 compared to placebo (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06347016, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.