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Study of Plozasiran for Adults with Severe Hypertriglyceridemia

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a condition known as severe hypertriglyceridemia, which is characterized by very high levels of triglycerides in the blood. Triglycerides are a type of fat found in the blood, and having too much can increase the risk of health problems like pancreatitis. The study will evaluate a treatment called Plozasiran, which is a new medication designed to help reduce these high triglyceride levels. Plozasiran is a synthetic compound that targets specific molecules in the body to lower triglyceride levels.

The purpose of this study is to assess how effective and safe Plozasiran is in reducing fasting triglyceride levels in adults with severe hypertriglyceridemia. Participants in the study will receive either Plozasiran or a placebo, which is a substance with no active medication. The study will last for about 12 months, during which participants will receive regular injections and have their triglyceride levels monitored at various points to see how they change over time.

Throughout the study, participants will be closely monitored for any changes in their health and any side effects they might experience. The goal is to determine if Plozasiran can significantly lower triglyceride levels compared to the placebo, and to see if it helps more participants reach healthier triglyceride levels. This research could lead to a new treatment option for people with severe hypertriglyceridemia, potentially improving their health and reducing the risk of complications associated with high triglyceride levels.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.

    Participants must have a diagnosis of severe hypertriglyceridemia, with documented fasting triglyceride levels of at least 500 mg/dL.

    Participants are required to follow dietary counseling and maintain a stable low-fat diet.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline fasting triglyceride levels.

    This involves two separate visits, at least 7 days apart, to ensure accurate baseline measurements.

  3. Step 3

    Treatment administration

    Participants receive either the plozasiran injection or a placebo.

    The medication is administered as a solution for injection using a pre-filled syringe.

    The route of administration is subcutaneous, meaning the injection is given under the skin.

  4. Step 4

    Ongoing monitoring

    Participants are monitored regularly to assess the efficacy and safety of the treatment.

    Fasting triglyceride levels are measured at various intervals, including months 10 and 12.

    The primary goal is to observe the percent change in fasting triglyceride levels from baseline to month 12.

  5. Step 5

    Evaluation of outcomes

    The study evaluates the proportion of participants achieving specific triglyceride level targets at months 10 and 12.

    Secondary outcomes include the rate of abdominal clinical events and the achievement of lower triglyceride levels.

  6. Step 6

    Completion of study

    The study is expected to conclude by October 2026.

    Final assessments are conducted to determine the overall efficacy and safety of the treatment.

Who can join the trial?

8 criteria

  • Must be a male or a non-pregnant, non-lactating female who is 18 years or older at the time of screening.
  • Must have a confirmed diagnosis of Severe Hypertriglyceridemia (SHTG), which means having very high levels of triglycerides in the blood.
  • Must have a medical history showing fasting triglyceride (TG) levels of 500 mg/dL or higher.
  • During the screening period, must have an average fasting TG level of 500 mg/dL or higher, measured at two separate visits that are at least 7 days apart but no more than 17 days apart.
  • Must have fasting LDL-C (low-density lipoprotein cholesterol) levels of 130 mg/dL or lower at screening.
  • Must have a screening HbA1c (a measure of blood sugar levels over time) of 8.5% or lower.
  • Must be willing to follow diet counseling and maintain a stable low-fat diet.
  • Must be taking standard lipid-lowering medications as per local guidelines, unless unable to tolerate them as determined by the study doctor.

Who cannot join the trial?

20 criteria

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication.
  • Patients who are unable to follow the study procedures.
  • Patients with a history of substance abuse.
  • Patients with certain heart conditions.
  • Patients with uncontrolled diabetes.
  • Patients with liver disease.
  • Patients with kidney disease.
  • Patients who are taking medications that might interfere with the study.
  • Patients with a history of cancer within the last five years.
  • Patients with a history of mental health disorders that are not well controlled.
  • Patients who have had a major surgery recently.
  • Patients with a history of blood disorders.
  • Patients with a history of autoimmune diseases.
  • Patients with a history of infections that are not well controlled.
  • Patients with a history of gastrointestinal disorders.
  • Patients with a history of lung diseases.
  • Patients with a history of neurological disorders.
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Investigated drugs

Plozasiran is a medication being studied for its ability to lower high levels of triglycerides in the blood. Triglycerides are a type of fat found in your blood, and having too much can increase the risk of heart disease. This study is focused on adults with severe hypertriglyceridemia, which means they have very high levels of triglycerides. The goal of using Plozasiran in this trial is to see if it can effectively reduce these levels and improve the patients' health.

What is already known about the treatment

Plozasiran – Plozasiran is administered as an injection, typically under the skin. It is currently being studied in clinical trials, specifically in a Phase 3 study, to assess its effectiveness and safety for treating severe hypertriglyceridemia, a condition characterized by very high levels of triglycerides in the blood. The medication works by targeting specific molecules in the body to reduce triglyceride levels, helping to manage this condition. Plozasiran is classified as a lipid-lowering agent, focusing on improving lipid profiles in affected individuals.

Investigated diseases

Severe Hypertriglyceridemia – Severe hypertriglyceridemia is a condition characterized by extremely high levels of triglycerides in the blood. Triglycerides are a type of fat that the body uses for energy, but when their levels become too high, it can lead to health problems. This condition can cause symptoms such as abdominal pain and may increase the risk of developing pancreatitis. Over time, the elevated triglyceride levels can contribute to the development of cardiovascular diseases. The progression of severe hypertriglyceridemia involves persistent high triglyceride levels, which can be influenced by genetic factors, lifestyle, and other health conditions. Managing triglyceride levels is crucial to prevent complications associated with this condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509300-14-00Protocol codeAROAPOC3-3003Estimated enrolment445 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).