New drug plozasiran aims to tame dangerous fat levels in blood

NCT ID NCT06347003

Disease control Sponsor: Arrowhead Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This Phase 3 trial tests plozasiran, an injectable drug, in 446 adults with severe hypertriglyceridemia (very high blood fats). Participants receive four doses over 12 months, and researchers measure how much triglyceride levels drop compared to placebo. The goal is to see if plozasiran can safely bring these levels down and reduce health risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: plozasiran (also called ARO-APOC3)
What this could lead to: If successful, plozasiran could offer a new treatment option to lower dangerously high triglycerides, reducing the risk of pancreatitis and other complications.
What could go wrong: This is a Phase 3 trial, but results are not yet available. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

446 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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) 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 * 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

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Conditions

The condition(s) this trial relates to.

hypertriglyceridemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe hypertriglyceridemia

Contacts and locations

Locations

Research Center 1

Garden Grove, California, 92844, United States
Research Center 1

Buenos Aires, C1430, Argentina
Research Center 1

Blacktown, New South Wales, 2148, Australia
Research Center 1

Wetteren, 9230, Belgium
Research Center 1

Campinas, São Paulo, 13083-190, Brazil
Research Center 1

Pleven, 5800, Bulgaria
Research Center 1

Brampton, Ontario, L6S 0C6, Canada
Research Center 1

Beijing, Xicheng, 10034, China
Research Center 1

Zagreb, 10000, Croatia
Research Center 1

Ostrava, 70200, Czechia
Research Center 1

Budapest, 1033, Hungary
Research Center 1

Roma, 00168, Italy
Research Center 1

Bucharest, 010192, Romania
Research Center 1

Košice, Košice Region, 040 01, Slovakia
Research Center 1

Valencia, 46010, Spain
Research Center 1

London, EC1M 6BQ, United Kingdom
Research Center 10

Mt. Dora, Florida, 32757, United States
Research Center 10

San Isidro, Buenos Aires, 1642, Argentina
Research Center 10

Vitória, Espírito Santo, 29055-450, Brazil
Research Center 10

Kardzhali, 6600, Bulgaria
Research Center 10

Suzhou, Jiangsu, 215002, China
Research Center 10

Katowice, 40-752, Poland
Research Center 11

Orlando, Florida, 32825, United States
Research Center 11

São Paulo, São Paulo, 05403-000, Brazil
Research Center 11

Rousse, 7000, Bulgaria
Research Center 11

Bengbu, Anhui, 233004, China
Research Center 11

Elblag, 82-300, Poland
Research Center 12

Pensacola, Florida, 32503, United States
Research Center 12

Salvador, Estado de Bahia, 40050-410, Brazil
Research Center 12

Blagoevgrad, 2700, Bulgaria
Research Center 12

Shanghai, Shanghai Municipality, 200050, China
Research Center 12

Lodz, 91-363, Poland
Research Center 13

Tamarac, Florida, 33321, United States
Research Center 13

Salvador, Estado de Bahia, 40323-010, Brazil
Research Center 13

Sofia, 1336, Bulgaria
Research Center 13

Xingtai, Hebei, 054099, China
Research Center 13

Krakow, 30-727, Poland
Research Center 14

Tampa, Florida, 33614, United States
Research Center 14

Salvador, Estado de Bahia, 41810-010, Brazil
Research Center 14

Sofia, 1680, Bulgaria
Research Center 14

Nanchang, 330006, China
Research Center 14

Wroclaw, 53-673, Poland
Research Center 15

Macon, Georgia, 31210, United States
Research Center 15

Sofia, 1527, Bulgaria
Research Center 15

Wenzhou, Zhejiang, 325000, China
Research Center 15

Żarów, Swidnica, 58-130, Poland
Research Center 16

Savannah, Georgia, 31401, United States
Research Center 16

Baotou, Inner Mongolia, 14010, China
Research Center 16

Wroclaw, 53-030, Poland
Research Center 17

Park Ridge, Illinois, 60068, United States
Research Center 17

Chengdu, Sichuan, 610072, China
Research Center 17

Krakow, 31-202, Poland
Research Center 18

Eunice, Louisiana, 70535, United States
Research Center 18

Changsha, Hunan, 410015, China
Research Center 18

Warsaw, 00-215, Poland
Research Center 19

Baltimore, Maryland, 21229, United States
Research Center 19

Guanzhou, Guangdong, 510080, China
Research Center 2

Lake Forest, California, 92630, United States
Research Center 2

Buenos Aires, C1425AGC, Argentina
Research Center 2

Box Hill, Victoria, 3138, Australia
Research Center 2

Namur, 5101, Belgium
Research Center 2

Curitiba, Paraná, 80730-150, Brazil
Research Center 2

Plovdiv, 4002, Bulgaria
Research Center 2

Sarnia, Ontario, N7T 4X3, Canada
Research Center 2

Yuncheng, Shanxi, 44000, China
Research Center 2

Krapinske Toplice, 49217, Croatia
Research Center 2

Uherské Hradiště, 68601, Czechia
Research Center 2

Budapest, 1132, Hungary
Research Center 2

Palermo, Sicily, 90127, Italy
Research Center 2

Cluj-Napoca, Cluj, 400000, Romania
Research Center 2

Žilina, 10010, Slovakia
Research Center 2

Barcelona, 08023, Spain
Research Center 2

Plymouth, Devpn, PL5 3JB, United Kingdom
Research Center 20

Flint, Michigan, 48532, United States
Research Center 20

Tianjin, Tianjin Municipality, 300121, China
Research Center 21

Minneapolis, Minnesota, 55455, United States
Research Center 21

Wuhan, Hubei, 430060, China
Research Center 22

Olive Branch, Mississippi, 38654, United States
Research Center 22

Beijing, Beijing Municipality, 100730, China
Research Center 23

Jefferson City, Missouri, 65109, United States
Research Center 23

Beijing, Beijing Municipality, 100191, China
Research Center 24

St Louis, Missouri, 63136, United States
Research Center 25

Omaha, Nebraska, 68144, United States
Research Center 26

Omaha, Nebraska, 68114, United States
Research Center 27

Las Vegas, Nevada, 89119, United States
Research Center 28

The Bronx, New York, 10455, United States
Research Center 29

Long Island City, New York, 11106, United States
Research Center 3

Montclair, California, 91763, United States
Research Center 3

Córdoba, X5006CBI, Argentina
Research Center 3

Heidelberg, Victoria, 3084, Australia
Research Center 3

Mechelen, 2800, Belgium
Research Center 3

Votuporanga, São Paulo, 15501-405, Brazil
Research Center 3

Pleven, 5800, Bulgaria
Research Center 3

Victoria, British Columbia, V8T 5G4, Canada
Research Center 3

Liaocheng, 252000, China
Research Center 3

Zagreb, 10000, Croatia
Research Center 3

Hodonín, 69501, Czechia
Research Center 3

Szeged, 6725, Hungary
Research Center 3

Rozzano, Milano, 20089, Italy
Research Center 3

Brasov, Brașov County, 500091, Romania
Research Center 3

Moldava nad Bodvou, Košice Region, 045 01, Slovakia
Research Center 3

Barcelona, 08035, Spain
Research Center 3

Torpoint, Cornwall, PL11 2TB, United Kingdom
Research Center 30

New York, New York, 10016, United States
Research Center 31

Rochester, New York, 14642, United States
Research Center 32

Vestal, New York, 13850, United States
Research Center 33

Morehead City, North Carolina, 28557, United States
Research Center 34

Winston-Salem, North Carolina, 27157, United States
Research Center 35

Cincinnati, Ohio, 45219, United States
Research Center 36

Columbus, Ohio, 43210, United States
Research Center 37

Norman, Oklahoma, 73072, United States
Research Center 38

Oklahoma City, Oklahoma, 73111, United States
Research Center 39

Powell, Tennessee, 37849, United States
Research Center 4

Panorama City, California, 91402, United States
Research Center 4

Córdoba, Córdoba Province, 5000, Argentina
Research Center 4

Concord, New South Wales, 2139, Australia
Research Center 4

Gozée, 6534, Belgium
Research Center 4

Belém, Pará, 66073-000, Brazil
Research Center 4

Plovdiv, 4001, Bulgaria
Research Center 4

Québec, Quebec, G1V 4W2, Canada
Research Center 4

Changsha, Hunan, 410011, China
Research Center 4

Zagreb, 10000, Croatia
Research Center 4

Prague, Prague, 140 59, Czechia
Research Center 4

Budapest, 1051, Hungary
Research Center 4

Milan, 20162, Italy
Research Center 4

Ploieşti, Jud. Prahova, 100342, Romania
Research Center 4

Banská Bystrica, 97401, Slovakia
Research Center 4

Zaragoza, 50009, Spain
Research Center 4

London, N12 8BU, United Kingdom
Research Center 40

El Paso, Texas, 79905, United States
Research Center 41

Houston, Texas, 77095, United States
Research Center 42

Houston, Texas, 77061, United States
Research Center 43

Houston, Texas, 77079, United States
Research Center 44

Houston, Texas, 77074, United States
Research Center 45

Houston, Texas, 77030, United States
Research Center 46

Houston, Texas, 77030, United States
Research Center 47

Houston, Texas, 77029, United States
Research Center 48

Laredo, Texas, 78041, United States
Research Center 49

Missouri City, Texas, 77459, United States
Research Center 5

Redding, California, 96001, United States
Research Center 5

Córdoba, X5000AAW, Argentina
Research Center 5

Merewether, New South Wales, 2291, Australia
Research Center 5

Roeselare, 8800, Belgium
Research Center 5

Belo Horizonte, Minas Gerais, 30220-140, Brazil
Research Center 5

Sofia, 1431, Bulgaria
Research Center 5

Waterloo, Ontario, N2TOC1, Canada
Research Center 5

Hangzhou, 311100, China
Research Center 5

Praha 4-Krc, 140 59, Czechia
Research Center 5

Veszprém, 8200, Hungary
Research Center 5

Brescia, 25123, Italy
Research Center 5

Timișoara, Timiș County, 300362, Romania
Research Center 5

Bratislava, 81109, Slovakia
Research Center 5

Torquay, Devon, TQ2 7AA, United Kingdom
Research Center 50

Plano, Texas, 75093, United States
Research Center 51

San Antonio, Texas, 78230, United States
Research Center 52

Seattle, Washington, 98109, United States
Research Center 6

Colorado Springs, Colorado, 80909, United States
Research Center 6

Buenos Aires, C1417, Argentina
Research Center 6

Crawley, Western Australia, 6009, Australia
Research Center 6

Hasselt, 3500, Belgium
Research Center 6

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Research Center 6

Sofia, 1404, Bulgaria
Research Center 6

Montreal, Quebec, H2W 1R7, Canada
Research Center 6

Luoyang, Henan, 471003, China
Research Center 6

Hradec Králové, 50005, Czechia
Research Center 6

Budapest, 1152, Hungary
Research Center 6

Bologna, 40138, Italy
Research Center 6

Alba Iulia, Jud. Alba, 510053, Romania
Research Center 6

Bardejov, 08501, Slovakia
Research Center 7

Hialeah, Florida, 33016, United States
Research Center 7

Temperley, Buenos Aires, B1834GUK, Argentina
Research Center 7

Clayton, Victoria, 3168, Australia
Research Center 7

São Paulo, São Paulo, 04266-010, Brazil
Research Center 7

Sofia, 1527, Bulgaria
Research Center 7

Halifax, B3H 1V7, Canada
Research Center 7

Guangzhou, Guangdong, 510180, China
Research Center 7

Praha 1-Nove Mesto, 11000, Czechia
Research Center 7

Bydgoszcz, 85-231, Poland
Research Center 7

Galati, 800291, Romania
Research Center 8

Lake City, Florida, 32055, United States
Research Center 8

Ramos Mejía, Buenos Aires, B1704ETD, Argentina
Research Center 8

Campina Grande do Sul, Paraná, 83430-000, Brazil
Research Center 8

Burgas, 8000, Bulgaria
Research Center 8

London, Ontario, N6A 5A5, Canada
Research Center 8

Liuzhou, Guangxi Zhuang, 545006, China
Research Center 8

Prague, Prague, 140 21, Czechia
Research Center 8

Krakow, 31-501, Poland
Research Center 8

Deva, 330084, Romania
Research Center 9

Miami Lakes, Florida, 33014, United States
Research Center 9

Córdoba, Córdoba Province, 5008, Argentina
Research Center 9

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Research Center 9

Plovdiv, 4004, Bulgaria
Research Center 9

Shanghai, Shanghai Municipality, 2000040, China
Research Center 9

Ústí nad Labem, 40113, Czechia
Research Center 9

Warsaw, 03-291, Poland
Research Center 9

Târgu Mureş, 540136, Romania

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