Severe HypertriglyceridemiaPhase 3SHASTA-3NCT06347003

Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

A Phase 3 study testing Plozasiran Injection in people with Severe Hypertriglyceridemia, run by Arrowhead Pharmaceuticals at 196 sites in 17 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: 446 participants
Where: 196 sitesin 17 countries
Study dates: 22 Jul 2024to 25 Aug 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

Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/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%
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 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
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
Acute pancreatitis within 4 weeks prior to screening
Body mass index >45kg/m^2
Note: Additional Inclusion/Exclusion criteria may apply per protocol

Trial locations and contacts

196 sites in 17 countries.

Country

City, postcode or hospital

196 sites in 17 countries

United States52 sites

Research Center 19
Baltimore, Maryland, 21229
Research Center 35
Cincinnati, Ohio, 45219
Research Center 6
Colorado Springs, Colorado, 80909
Research Center 36
Columbus, Ohio, 43210
Research Center 40
El Paso, Texas, 79905
Research Center 18
Eunice, Louisiana, 70535
Research Center 20
Flint, Michigan, 48532
Research Center 1
Garden Grove, California, 92844
Research Center 7
Hialeah, Florida, 33016
Research Center 47
Houston, Texas, 77029
Research Center 45
Houston, Texas, 77030
Research Center 46
Houston, Texas, 77030
Research Center 42
Houston, Texas, 77061
Research Center 44
Houston, Texas, 77074
Research Center 43
Houston, Texas, 77079
Research Center 41
Houston, Texas, 77095
Research Center 23
Jefferson City, Missouri, 65109
Research Center 8
Lake City, Florida, 32055
Research Center 2
Lake Forest, California, 92630
Research Center 48
Laredo, Texas, 78041
Research Center 27
Las Vegas, Nevada, 89119
Research Center 29
Long Island City, New York, 11106
Research Center 15
Macon, Georgia, 31210
Research Center 9
Miami Lakes, Florida, 33014
Research Center 21
Minneapolis, Minnesota, 55455
Research Center 49
Missouri City, Texas, 77459
Research Center 3
Montclair, California, 91763
Research Center 33
Morehead City, North Carolina, 28557
Research Center 10
Mt. Dora, Florida, 32757
Research Center 30
New York, New York, 10016
Research Center 37
Norman, Oklahoma, 73072
Research Center 38
Oklahoma City, Oklahoma, 73111
Research Center 22
Olive Branch, Mississippi, 38654
Research Center 26
Omaha, Nebraska, 68114
Research Center 25
Omaha, Nebraska, 68144
Research Center 11
Orlando, Florida, 32825
Research Center 4
Panorama City, California, 91402
Research Center 17
Park Ridge, Illinois, 60068
Research Center 12
Pensacola, Florida, 32503
Research Center 50
Plano, Texas, 75093
Research Center 39
Powell, Tennessee, 37849
Research Center 5
Redding, California, 96001
Research Center 31
Rochester, New York, 14642
Research Center 51
San Antonio, Texas, 78230
Research Center 16
Savannah, Georgia, 31401
Research Center 52
Seattle, Washington, 98109
Research Center 24
St Louis, Missouri, 63136
Research Center 13
Tamarac, Florida, 33321
Research Center 14
Tampa, Florida, 33614
Research Center 28
The Bronx, New York, 10455
Research Center 32
Vestal, New York, 13850
Research Center 34
Winston-Salem, North Carolina, 27157

Other trials in United States

China23 sites

Research Center 16
Baotou, Inner Mongolia, 14010
Research Center 23
Beijing, Beijing Municipality, 100191
Research Center 22
Beijing, Beijing Municipality, 100730
Research Center 1
Beijing, Xicheng, 10034
Research Center 11
Bengbu, Anhui, 233004
Research Center 4
Changsha, Hunan, 410011
Research Center 18
Changsha, Hunan, 410015
Research Center 17
Chengdu, Sichuan, 610072
Research Center 7
Guangzhou, Guangdong, 510180
Research Center 19
Guanzhou, Guangdong, 510080
Research Center 5
Hangzhou, 311100
Research Center 3
Liaocheng, 252000
Research Center 8
Liuzhou, Guangxi Zhuang, 545006
Research Center 6
Luoyang, Henan, 471003
Research Center 14
Nanchang, 330006
Research Center 9
Shanghai, Shanghai Municipality, 2000040
Research Center 12
Shanghai, Shanghai Municipality, 200050
Research Center 10
Suzhou, Jiangsu, 215002
Research Center 20
Tianjin, Tianjin Municipality, 300121
Research Center 15
Wenzhou, Zhejiang, 325000
Research Center 21
Wuhan, Hubei, 430060
Research Center 13
Xingtai, Hebei, 054099
Research Center 2
Yuncheng, Shanxi, 44000

Other trials in China

Bulgaria15 sites

Research Center 12
Blagoevgrad, 2700
Research Center 8
Burgas, 8000
Research Center 10
Kardzhali, 6600
Research Center 1
Pleven, 5800
Research Center 3
Pleven, 5800
Research Center 4
Plovdiv, 4001
Research Center 2
Plovdiv, 4002
Research Center 9
Plovdiv, 4004
Research Center 11
Rousse, 7000
Research Center 13
Sofia, 1336
Research Center 6
Sofia, 1404
Research Center 5
Sofia, 1431
Research Center 15
Sofia, 1527
Research Center 7
Sofia, 1527
Research Center 14
Sofia, 1680

Other trials in Bulgaria

Brazil14 sites

Research Center 4
Belém, Pará, 66073-000
Research Center 5
Belo Horizonte, Minas Gerais, 30220-140
Research Center 8
Campina Grande do Sul, Paraná, 83430-000
Research Center 1
Campinas, São Paulo, 13083-190
Research Center 2
Curitiba, Paraná, 80730-150
Research Center 6
Porto Alegre, Rio Grande do Sul, 90035-903
Research Center 9
Porto Alegre, Rio Grande do Sul, 90430-001
Research Center 12
Salvador, Estado de Bahia, 40050-410
Research Center 13
Salvador, Estado de Bahia, 40323-010
Research Center 14
Salvador, Estado de Bahia, 41810-010
Research Center 7
São Paulo, São Paulo, 04266-010
Research Center 11
São Paulo, São Paulo, 05403-000
Research Center 10
Vitória, Espírito Santo, 29055-450
Research Center 3
Votuporanga, São Paulo, 15501-405

Other trials in Brazil

Poland12 sites

Research Center 7
Bydgoszcz, 85-231
Research Center 11
Elblag, 82-300
Research Center 10
Katowice, 40-752
Research Center 13
Krakow, 30-727
Research Center 17
Krakow, 31-202
Research Center 8
Krakow, 31-501
Research Center 12
Lodz, 91-363
Research Center 18
Warsaw, 00-215
Research Center 9
Warsaw, 03-291
Research Center 16
Wroclaw, 53-030
Research Center 14
Wroclaw, 53-673
Research Center 15
Żarów, Swidnica, 58-130

Other trials in Poland

Argentina10 sites

Research Center 6
Buenos Aires, C1417
Research Center 2
Buenos Aires, C1425AGC
Research Center 1
Buenos Aires, C1430
Research Center 4
Córdoba, Córdoba Province, 5000
Research Center 9
Córdoba, Córdoba Province, 5008
Research Center 5
Córdoba, X5000AAW
Research Center 3
Córdoba, X5006CBI
Research Center 8
Ramos Mejía, Buenos Aires, B1704ETD
Research Center 10
San Isidro, Buenos Aires, 1642
Research Center 7
Temperley, Buenos Aires, B1834GUK

Other trials in Argentina

Czechia9 sites

Research Center 3
Hodonín, 69501
Research Center 6
Hradec Králové, 50005
Research Center 1
Ostrava, 70200
Research Center 8
Prague, Prague, 140 21
Research Center 4
Prague, Prague, 140 59
Research Center 7
Praha 1-Nove Mesto, 11000
Research Center 5
Praha 4-Krc, 140 59
Research Center 2
Uherské Hradiště, 68601
Research Center 9
Ústí nad Labem, 40113

Other trials in Czechia

Romania9 sites

Research Center 6
Alba Iulia, Jud. Alba, 510053
Research Center 3
Brasov, Brașov County, 500091
Research Center 1
Bucharest, 010192
Research Center 2
Cluj-Napoca, Cluj, 400000
Research Center 8
Deva, 330084
Research Center 7
Galati, 800291
Research Center 4
Ploieşti, Jud. Prahova, 100342
Research Center 9
Târgu Mureş, 540136
Research Center 5
Timișoara, Timiș County, 300362

Other trials in Romania

Canada8 sites

Research Center 1
Brampton, Ontario, L6S 0C6
Research Center 7
Halifax, B3H 1V7
Research Center 8
London, Ontario, N6A 5A5
Research Center 6
Montreal, Quebec, H2W 1R7
Research Center 4
Québec, Quebec, G1V 4W2
Research Center 2
Sarnia, Ontario, N7T 4X3
Research Center 3
Victoria, British Columbia, V8T 5G4
Research Center 5
Waterloo, Ontario, N2TOC1

Other trials in Canada

Australia7 sites

Research Center 1
Blacktown, New South Wales, 2148
Research Center 2
Box Hill, Victoria, 3138
Research Center 7
Clayton, Victoria, 3168
Research Center 4
Concord, New South Wales, 2139
Research Center 6
Crawley, Western Australia, 6009
Research Center 3
Heidelberg, Victoria, 3084
Research Center 5
Merewether, New South Wales, 2291

Other trials in Australia

Belgium6 sites

Research Center 4
Gozée, 6534
Research Center 6
Hasselt, 3500
Research Center 3
Mechelen, 2800
Research Center 2
Namur, 5101
Research Center 5
Roeselare, 8800
Research Center 1
Wetteren, 9230

Other trials in Belgium

Hungary6 sites

Research Center 1
Budapest, 1033
Research Center 4
Budapest, 1051
Research Center 2
Budapest, 1132
Research Center 6
Budapest, 1152
Research Center 3
Szeged, 6725
Research Center 5
Veszprém, 8200

Other trials in Hungary

Italy6 sites

Research Center 6
Bologna, 40138
Research Center 5
Brescia, 25123
Research Center 4
Milan, 20162
Research Center 2
Palermo, Sicily, 90127
Research Center 1
Roma, 00168
Research Center 3
Rozzano, Milano, 20089

Other trials in Italy

Slovakia6 sites

Research Center 4
Banská Bystrica, 97401
Research Center 6
Bardejov, 08501
Research Center 5
Bratislava, 81109
Research Center 1
Košice, Košice Region, 040 01
Research Center 3
Moldava nad Bodvou, Košice Region, 045 01
Research Center 2
Žilina, 10010

Other trials in Slovakia

United Kingdom5 sites

Research Center 1
London, EC1M 6BQ
Research Center 4
London, N12 8BU
Research Center 2
Plymouth, Devpn, PL5 3JB
Research Center 3
Torpoint, Cornwall, PL11 2TB
Research Center 5
Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Croatia4 sites

Research Center 2
Krapinske Toplice, 49217
Research Center 1
Zagreb, 10000
Research Center 3
Zagreb, 10000
Research Center 4
Zagreb, 10000

Other trials in Croatia

Spain4 sites

Research Center 2
Barcelona, 08023
Research Center 3
Barcelona, 08035
Research Center 1
Valencia, 46010
Research Center 4
Zaragoza, 50009

Other trials in Spain

About this study

Official title: Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran 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 NCT06347003
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 Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo
Measured: Baseline, Month 12

Secondary outcomes (20)

Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
Measured: Baseline, Month 10
Proportion of Participants 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 Participants 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 participants 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 HbA1c 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 Participants 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 Participants Receiving Plozasiran Over Time Through Month 12
Measured: From first dose of study drug through Month 12
Change and/or percent change from baseline to Month 12 in liver fat content using MRI-PDFF, only in a subset of subjects
Measured: Baseline, Month 12

Timeline

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

22 Jul 202425 Aug 2026

First posted4 Apr 2024
Study start22 Jul 2024
Primary completion12 Jun 2026
Study completion25 Aug 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: 446 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06347003
Sponsor's protocol ID: AROAPOC3-3003
Other IDs: 2023-509300-14, 2023
Acronym: SHASTA-3
Status last verified: Oct 2026
First submitted: 29 Mar 2024
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

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Severe Hypertriglyceridemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
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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
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All Severe Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 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 Plozasiran in Adults With Severe Hypertriglyceridemia
ClinicalTrials.gov ID: NCT06347003
Acronym / sponsor ID: SHASTA-3 / AROAPOC3-3003
Conditions: Severe Hypertriglyceridemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 446 participants (actual)
Lead sponsor: Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 22 Jul 2024 (actual)
Primary completion: 12 Jun 2026 (actual)
Study completion: 25 Aug 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 (7 listed)

Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/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%

Key exclusion criteria (6 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
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
Acute pancreatitis within 4 weeks prior to screening
Body mass index >45kg/m^2

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 Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo
Time frame: Baseline, Month 12

20 secondary outcomes

Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
Time frame: Baseline, Month 10
Proportion of Participants 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 Participants 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 participants 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 HbA1c 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 Participants 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 Participants Receiving Plozasiran Over Time Through Month 12
Time frame: From first dose of study drug through Month 12
Change and/or percent change from baseline to Month 12 in liver fat content using MRI-PDFF, only in a subset of subjects
Time frame: Baseline, 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 8 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: No

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.

196 sites in 17 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 196 sites in 17 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 7 inclusion and 6 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 8 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 196 sites in United States, China, Bulgaria, Brazil, Poland and 12 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 Triglyceride (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 NCT06347003, 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 8 Oct 2026.