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Study of Plozasiran to prevent acute pancreatitis in adults with severe hypertriglyceridemia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Severe Hypertriglyceridemia (SHTG), a condition characterized by very high levels of triglycerides in the blood that puts people at high risk of developing Acute Pancreatitis. The study aims to test how well a new medication called Plozasiran works in preventing episodes of acute pancreatitis in adults with this condition.

The research will evaluate the effectiveness and safety of Plozasiran compared to placebo in people who have experienced at least two episodes of acute pancreatitis in the past. The medication will be given as a subcutaneous injection, which means it is injected under the skin using a pre-filled syringe. The study medication or placebo will be administered over a period of 48 months.

During the study, researchers will monitor how the treatment affects triglyceride levels in the blood and how well it prevents new episodes of acute pancreatitis. They will also track how the treatment impacts participants' daily activities and overall health status. The medication being tested, Plozasiran, is designed to reduce the production of a protein called Apolipoprotein C-III, which plays a role in controlling triglyceride levels in the body.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your fasting triglyceride levels will be measured to confirm they are at least 1,000 mg/dL

    Your blood sugar control (HbA1c) will be checked to ensure it is 9.0% or lower

    Your LDL cholesterol will be verified to be 130 mg/dL or lower

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either Plozasiran or a placebo

    Neither you nor your doctor will know which treatment you are receiving

    The medication will be provided in pre-filled syringes for injection under the skin

  3. Step 3

    Treatment period

    You will receive regular injections under the skin throughout the study period

    You will need to maintain a stable low-fat diet during the entire study

    You will continue taking your regular prescribed medications for managing blood fats

  4. Step 4

    Monitoring

    Your triglyceride levels will be checked regularly, particularly at month 3 and month 12

    Your overall health status will be monitored throughout the study

    Any stomach pain episodes or other health issues will be recorded

    You will complete questionnaires about your health status and daily activities

  5. Step 5

    Study duration

    The study will continue until late 2029

    Regular check-ups will be scheduled throughout the study period

    Your participation will help evaluate how effective the medication is in preventing acute pancreatitis

Who can join the trial?

10 criteria

  • Must be at least 18 years old
  • Can be male or female, but females must not be pregnant or breastfeeding and must not plan to become pregnant during the study
  • Must have been diagnosed with severe hypertriglyceridemia (a condition with very high levels of fat in the blood)
  • Must have documented history of fasting blood fat levels of at least 880 mg/dL
  • Must have current fasting blood fat levels of at least 1,000 mg/dL during screening
  • Must have experienced at least two episodes of acute pancreatitis (sudden inflammation of the pancreas) not caused by gallstones or alcohol, with at least one episode in the past 12 months
  • Must have fasting LDL cholesterol levels of 130 mg/dL or lower during screening
  • Must have HbA1c (a measure of blood sugar control) of 9.0% or lower during screening
  • Must be willing to follow dietary advice and maintain a low-fat diet
  • Must be taking standard medications for lowering blood fats (unless documented as unable to tolerate these medications)

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to similar medications
  • Current participation in other clinical trials
  • Severe liver problems (as measured by liver function tests)
  • Severe kidney problems (as indicated by kidney function tests)
  • Uncontrolled hypertension (high blood pressure)
  • Recent heart attack or stroke (within last 6 months)
  • Active cancer or ongoing cancer treatment
  • History of acute pancreatitis (sudden inflammation of pancreas) in the past 6 months
  • Unstable medical conditions that could interfere with study participation
  • Regular use of medications that could interact with the study drug
  • Alcohol or substance abuse within the past year
  • Mental health conditions that could affect ability to follow study procedures
  • Unable to provide informed consent
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Investigated drugs

Plozasiran is an investigational medication being studied for treating severe hypertriglyceridemia (very high levels of triglycerides in the blood) in adults who are at high risk of developing acute pancreatitis. This medication is designed to help reduce the risk of sudden inflammation of the pancreas by controlling triglyceride levels in the blood.

What is already known about the treatment

Plozasiran - A novel investigational medication administered through subcutaneous injection, currently being studied in Phase 3 clinical trials for the treatment of severe hypertriglyceridemia (SHTG) and prevention of acute pancreatitis. This drug belongs to the class of small interfering RNA (siRNA) therapeutics, designed to reduce triglyceride levels in the blood by targeting specific genes involved in lipid metabolism. Plozasiran represents a potential therapeutic breakthrough for patients with dangerously high triglyceride levels who are at increased risk of developing acute pancreatitis, working at the molecular level to modify the expression of genes responsible for triglyceride production.

Investigated diseases

  • Severe Hypertriglyceridemia (SHTG)

    A metabolic disorder characterized by abnormally high levels of triglycerides (fat molecules) in the blood, specifically exceeding 500 mg/dL. The condition develops when the body cannot effectively break down or remove triglycerides from the bloodstream. SHTG can be inherited genetically or develop due to other health conditions, poor diet, or certain medications. The excess triglycerides can accumulate in various organs throughout the body. This condition often causes symptoms such as recurrent abdominal pain, fatty deposits under the skin, and enlargement of the liver or spleen.

  • Acute Pancreatitis (AP)

    An inflammatory condition where the pancreas becomes suddenly inflamed. The condition occurs when digestive enzymes become activated while still inside the pancreas, causing the organ to begin digesting itself. AP typically causes intense pain in the upper abdomen, which can spread to the back. The inflammation usually develops over a short period, causing symptoms such as nausea, vomiting, and tenderness in the abdomen. The condition can be triggered by various factors, including very high blood triglyceride levels.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518206-40-00Protocol codeAROAPOC3-3011Estimated enrolment476 patientsSponsorArrowhead Pharmaceuticals Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).