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New shot every 3 months could stop pancreatitis in people with Sky-High triglycerides

NCT ID NCT06880770

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This phase 3 trial tests a drug called plozasiran in 288 adults with severe hypertriglyceridemia (very high blood fats) who have had at least two pancreatitis attacks. Participants receive either the drug or a placebo every three months. The main goal is to see if the drug can prevent future pancreatitis episodes and lower triglyceride levels.

What this could mean

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

Active substance
plozasiran (a drug injection given every three months)
What this could lead to
If it works, this could offer a new way to lower dangerously high fat levels in the blood and reduce the risk of painful pancreatitis attacks.
What could go wrong
This is still a clinical trial, so it is not yet proven to work. The study is relatively small (288 people) and results may not apply to everyone. Possible 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

About 288 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2029

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 * Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg/dL (≥ 10 mmol/L) * Documented evidence of at least 1 prior AP event not attributed to other etiologies occurring within the last 60 months prior to Screening. * Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg/dL (≤ 3.37 mmol/L) at Screening * Screening hemoglobin A1c (HbA1c) ≤ 9.5% * 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, or a treatment failure as determined by the Investigator) 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. * Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives lives before day 1. Whichever is longer. * AP ≤ 4 weeks prior to Randomization/Day 1 * Body mass index (BMI) \> 45 kg/m\^2 * Any planned bariatric surgery or similar procedures to induce weight lost starting at consent through End of Study (EOS) * Planned coronary intervention (e.g. stent placement or heart bypass) during the study * History of arterial revascularization within 16 weeks of Screening * History of acute coronary syndrome event within 24 weeks of Screening * Recent atherosclerotic cardiovascular disease (ASCVD) event within 24 weeks of Screening * Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days of Screening. Individuals with stable well-controlled atrial arrhythmia will be allowed to participate in the study * History of pacemaker or automatic implantable cardioverter defibrillators implant within 30 days before Screening * New York Heart Association Class III-IV heart failure or last known ejection fraction of \< 30% * Current diagnosis of nephrotic syndrome * Chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73 m\^2 * Liver disease defined as cirrhosis or Child-Pugh Class B and C, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5× Upper Limit of Normal (ULN) at Screening Note: Additional Inclusion/Exclusion Criteria may apply per protocol

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Conditions

The condition(s) this trial relates to.

hypertriglyceridemia acute pancreatitis prevention target

As listed by the trial registrant

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

Severe hypertriglyceridemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    121 sites in 22 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Research Site 1

    RECRUITING

    Mesquite, Texas, 75149, United States

  • Clinical Research Site 2

    RECRUITING

    San Antonio, Texas, 78233, United States

  • Clinical Research Site 3

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • Clinical Research Site 4

    RECRUITING

    Santa Clarita, California, 91321, United States

  • Clinical Research Site 5

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    North Platte, Nebraska, 69101, United States

  • Clinical Research Site 6

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Clinical Research Site 7

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Research Center

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    Plovdiv, 4002, Bulgaria

  • Research Center

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    Beijing, Beijing Municipality, 100730, China

  • Research Center

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    Baotou, Inner Mongolia, 014010, China

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    Nanchang, Jiangxi, 330006, China

  • Research Center

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    Shanghai, Shanghai Municipality, 201620, China

  • Research Center

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    Hangzhou, Zhejiang, 310000, China

  • Research Center

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    Amman, 11821, Jordan

  • Research Center

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    Irbid, 21166, Jordan

  • Research Center

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    Irbid, 22110, Jordan

  • Research Center

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    Belgrade, 11000, Serbia

  • Research Center

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    Zaječar, 19000, Serbia

  • Research Center

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    Gothenburg, 41345, Sweden

  • Research Center

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    Stockholm, 14186, Sweden

  • Research Site

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    Los Angeles, California, 90027, United States

  • Research Site

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    New Haven, Connecticut, 06519, United States

  • Research Site

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    Indianapolis, Indiana, 46202, United States

  • Research Site

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    Kansas City, Kansas, 66160, United States

  • Research Site

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    Ann Arbor, Michigan, 48109, United States

  • Research Site

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    St Louis, Missouri, 63110, United States

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    New York, New York, 10029, United States

  • Research Site

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    Wilmington, North Carolina, 28412, United States

  • Research Site

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    Pittsburgh, Pennsylvania, 15213, United States

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    Seattle, Washington, 98109, United States

  • Research Site

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    Ramos Mejía, Buenos Aires, 1704, Argentina

  • Research Site

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    Córdoba, Córdoba Province, 5000, Argentina

  • Research Site

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    Córdoba, Córdoba Province, X5003DCE, Argentina

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    Rosario, Santa Fe Province, 2000, Argentina

  • Research Site

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    Ciudad Autonoma Buenos Aires, C1430CKE, Argentina

  • Research Site

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    Graz, 8036, Austria

  • Research Site

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    Linz, 4021, Austria

  • Research Site

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    Vienna, 1130, Austria

  • Research Site

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    Fortaleza, Ceará, 60430-370, Brazil

  • Research Site

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    Belo Horizonte, Minas Gerais, 30150-274, Brazil

  • Research Site

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    Belo Horizonte, Minas Gerais, 30150-320, Brazil

  • Research Site

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    Belo Horizonte, Minas Gerais, 30220-140, Brazil

  • Research Site

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    Curitiba, Paraná, 80230-130, Brazil

  • Research Site

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    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Research Site

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    Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

  • Research Site

    RECRUITING

    Pôrto Alegre, Rio Grande do Sul, 90050-170, Brazil

  • Research Site

    RECRUITING

    São Paulo, São Paulo, 05403-900, Brazil

  • Research Site

    NOT_YET_RECRUITING

    São Paulo, São Paulo, 99999, Brazil

  • Research Site

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    São Paulo, 01221-020, Brazil

  • Research Site

    RECRUITING

    Burgas, 8000, Bulgaria

  • Research Site

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    Pleven, 5800, Bulgaria

  • Research Site

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    Plovdiv, 4003, Bulgaria

  • Research Site

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    Rousse, 7013, Bulgaria

  • Research Site

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    Sofia, 1404, Bulgaria

  • Research Site

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    Sofia, 1431, Bulgaria

  • Research Site

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    Stara Zagora, 6000, Bulgaria

  • Research Site

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    Montreal, Quebec, H2W 1R7, Canada

  • Research Site

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    Guangzhou, Guangdong, 510080, China

  • Research Site

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    Guiyang, Guizhou, 550000, China

  • Research Site

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    Harbin, Heilongjiang, 150040, China

  • Research Site

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    Luoyang, Henan, 471000, China

  • Research Site

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    Luoyang, Henan, 471002, China

  • Research Site

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    Nanyang, Henan, 473000, China

  • Research Site

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    Zhuzhou, Hunan, 412000, China

  • Research Site

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    Chifeng, Inner Mongolia, 024099, China

  • Research Site

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    Chengdu, Sichuan, 610041, China

  • Research Site

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • Research Site

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    Wenzhou, Zhejiang, 325000, China

  • Research Site

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    Beijing, 100053, China

  • Research Site

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    Changsha, 410015, China

  • Research Site

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    Chengdu, 610074, China

  • Research Site

    RECRUITING

    Ch’ang-ch’un, 130021, China

  • Research Site

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    Nanjing, 210002, China

  • Research Site

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    Barranquilla, 080020, Colombia

  • Research Site

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    Bogotá, 111211, Colombia

  • Research Site

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    Bogotá, 111411, Colombia

  • Research Site

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    Cali, 760042, Colombia

  • Research Site

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    Cali, 760046, Colombia

  • Research Site

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    Floridablanca, 681004, Colombia

  • Research Site

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    Puerto Colombia, 081007, Colombia

  • Research Site

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    Budapest, 1083, Hungary

  • Research Site

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    Budapest, 1132, Hungary

  • Research Site

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    Pécs, 7624, Hungary

  • Research Site

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    Szeged, 6725, Hungary

  • Research Site

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    Ashkelon, 7830604, Israel

  • Research Site

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    Jerusalem, 9103102, Israel

  • Research Site

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    Petah Tikva, 4941492, Israel

  • Research Site

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    Ramat Gan, 5265601, Israel

  • Research Site

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    Amman, 11190, Jordan

  • Research Site

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    Amman, 11942, Jordan

  • Research Site

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    Riga, 1002, Latvia

  • Research Site

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    Riga, LV-1079, Latvia

  • Research Site

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    Tukums, LV-3101, Latvia

  • Research Site

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    Kaunas, LT-49387, Lithuania

  • Research Site

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    Kaunas, LT-49449, Lithuania

  • Research Site

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    Guadalajara, Jalisco, 44670, Mexico

  • Research Site

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    Mexico City, Mexico City, 06700, Mexico

  • Research Site

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    Querétaro City, Querétaro, 76000, Mexico

  • Research Site

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    Durango, 34000, Mexico

  • Research Site

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    Muscat, 123, Oman

  • Research Site

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    Riyadh, 11211, Saudi Arabia

  • Research Site

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    Riyadh, 11426, Saudi Arabia

  • Research Site

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    Riyadh, 11472, Saudi Arabia

  • Research Site

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    Belgrade, 11000, Serbia

  • Research Site

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    Pančevo, 26000, Serbia

  • Research Site

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    Singapore, 119074, Singapore

  • Research Site

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    Singapore, 768828, Singapore

  • Research Site

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    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Research Site

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    Jeonju, Jeollabuk-do, 54907, South Korea

  • Research Site

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    Busan, 49201, South Korea

  • Research Site

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    Sejong, 30099, South Korea

  • Research Site

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    Seoul, 02841, South Korea

  • Research Site

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    Seoul, 05505, South Korea

  • Research Site

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    Seoul, 06351, South Korea

  • Research Site

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    Seoul, 06591, South Korea

  • Research Site

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    Abu Dhabi, 133500, United Arab Emirates

  • Research Site

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    Abu Dhabi, 51900, United Arab Emirates

  • Research Site

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    Al Ain City, 15258, United Arab Emirates

  • Research Site

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    Torquay, Devon, TQ2 7AA, United Kingdom

  • Research Site

    RECRUITING

    London, Greater London, EC1M 6BQ, United Kingdom

  • Research Site

    RECRUITING

    Dundee, Tayside Region, DD1 9SY, United Kingdom

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