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Study on Plozasiran and ARO-APOC3 for 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 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 given as an injection. Plozasiran is a new type of medication that works by targeting a specific protein involved in the production of triglycerides. The study will also use a placebo for comparison.

The purpose of this study is to see how effective Plozasiran is at reducing triglyceride levels in people with severe hypertriglyceridemia. Participants in the study will receive either Plozasiran or a placebo and will be monitored over a period of 12 months. During this time, the study will measure changes in triglyceride levels and monitor for any side effects. The goal is to determine if Plozasiran can significantly lower triglyceride levels compared to the placebo.

Participants will receive regular injections and attend scheduled visits to track their progress. The study aims to provide valuable information on the safety and effectiveness of Plozasiran, which could lead to new treatment options for people with severe hypertriglyceridemia. This research is important for understanding how to better manage this condition and improve patient outcomes.

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.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health metrics, including fasting triglyceride levels and other relevant health indicators.

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

  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 injection is given subcutaneously, which means it is administered under the skin.

  4. Step 4

    Ongoing monitoring

    Regular monitoring of fasting triglyceride levels is conducted throughout the study to assess the effectiveness of the treatment.

    Participants attend scheduled visits to track changes in triglyceride levels and overall health.

  5. Step 5

    Evaluation of results

    The primary goal is to measure the percent change in fasting triglyceride levels from the start of the study to Month 12.

    Secondary evaluations include the proportion of participants achieving specific triglyceride level targets and the rate of abdominal clinical events.

  6. Step 6

    Completion of study

    The study is expected to conclude by October 2026, with final assessments and data collection occurring at the end of the study period.

    Participants receive a summary of their health outcomes and any relevant findings from the study.

Who can join the trial?

8 criteria

  • Must be a male or a non-pregnant, non-lactating female who is at least 18 years old 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 history of fasting triglyceride (TG) levels of at least 500 mg/dL (5.65 mmol/L) documented in medical records.
  • Must have an average fasting TG level of at least 500 mg/dL (5.65 mmol/L) measured at two separate visits, with the visits being at least 7 days apart but no more than 17 days apart during the screening period.
  • Must have a fasting LDL-C (low-density lipoprotein cholesterol) level of 130 mg/dL (3.37 mmol/L) or less at screening.
  • Must have a screening HbA1c (a measure of blood sugar levels over time) of 8.5% or less.
  • 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 they are documented as intolerant to these medications by the study doctor.

Who cannot join the trial?

10 criteria

  • Individuals with other serious health conditions that might interfere with the study.
  • Pregnant or breastfeeding women.
  • People who are unable to give informed consent, which means they cannot fully understand the study and agree to participate.
  • Participants in another clinical trial at the same time.
  • Individuals with a history of drug or alcohol abuse.
  • People with allergies to the study medication or its ingredients.
  • Anyone who has had a recent major surgery.
  • Individuals with unstable mental health conditions.
  • People with certain heart conditions that are not well-controlled.
  • Individuals with severe liver or kidney disease.
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Investigated drugs

Plozasiran is a medication being studied for its ability to lower high levels of triglycerides in the blood. This study is focused on adults who have severe hypertriglyceridemia, a condition where there are too many triglycerides, a type of fat, in the blood. The goal of using Plozasiran in this trial is to see if it can effectively reduce these levels, which can help in managing the condition and potentially reduce the risk of related health issues.

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 and reducing the production of specific proteins involved in triglyceride metabolism, thereby lowering triglyceride levels. 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 present in excess, they can lead to health issues. This condition can result from genetic factors, lifestyle choices, or other underlying health problems. Over time, severe hypertriglyceridemia can contribute to the development of pancreatitis, a painful inflammation of the pancreas. It may also be associated with an increased risk of cardiovascular diseases. Managing triglyceride levels is crucial to prevent complications associated with this condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509301-80-00Protocol codeAROAPOC3-3004Estimated enrolment300 patientsSponsorArrowhead Pharmaceuticals Inc.

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