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Study on the Effects of Pegozafermin and Simvastatin for Patients with Severe High Triglycerides

Fast replyRegistered drugNo 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. The study will evaluate a treatment called Pegozafermin, which is a solution for injection. Pegozafermin is also known by its code name BIO89-100. The purpose of the study is to determine how Pegozafermin affects triglyceride levels in people with Severe Hypertriglyceridemia after 26 weeks of treatment. Participants in the study will receive either Pegozafermin or a placebo, which is a substance with no active medication.

In addition to Pegozafermin, the study involves the use of Simvastatin, a medication commonly used to lower cholesterol levels. Simvastatin will be provided in the form of film-coated tablets. Participants will continue their usual lipid-modifying therapy, which helps manage cholesterol levels, throughout the study. The study will last for a total of 52 weeks, with the main focus on changes in triglyceride levels at the 26-week mark.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study will also look at changes in other cholesterol levels, such as non-high-density lipoprotein cholesterol (non-HDL-C) and high-density lipoprotein cholesterol (HDL-C), as well as liver fat content using MRI scans. The goal is to gather information on the safety and effectiveness of Pegozafermin in managing Severe Hypertriglyceridemia.

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

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as age and current health status.

    Participants are informed about the need to maintain stable medication, eating, and exercise habits throughout the study.

  2. Step 2

    Medication stabilization period

    A period is designated for stabilizing medication and lifestyle. This involves maintaining consistent habits related to medication, diet, and exercise.

  3. Step 3

    Treatment phase

    Participants receive the study medication, pegozafermin, administered as a solution for injection under the skin (subcutaneous use).

    The treatment lasts for 26 weeks, during which the effect on fasting serum triglyceride levels is monitored.

  4. Step 4

    Additional medication

    Participants may also be on a stable background of simvastatin, taken orally as a 10 mg film-coated tablet, to manage cholesterol levels.

  5. Step 5

    Monitoring and assessments

    Regular assessments are conducted to monitor changes in triglyceride levels and other cholesterol-related measures.

    These assessments occur at specified intervals, including at week 26 and week 52.

  6. Step 6

    End of treatment evaluation

    At the end of the 26-week treatment period, a final evaluation is conducted to assess the primary and secondary outcomes of the study.

    This includes measuring changes in triglyceride levels and other health indicators.

Who can join the trial?

3 criteria

  • Must be at least 22 years old.
  • Must be willing to maintain stable medication, eating, and exercise habits during the study.
  • Must be on stable background Lipid Modifying Therapy (LMT) for at least 4 weeks before the study. This means taking medication to help manage cholesterol and fat levels in the blood.

Who cannot join the trial?

3 criteria

  • Patients with **Severe Hypertriglyceridemia** cannot participate. This means having very high levels of triglycerides, which are a type of fat found in your blood.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This includes groups of people who might need special protection or care.
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Investigated drugs

Pegozafermin is a medication being studied for its potential to help people with a condition called Severe Hypertriglyceridemia, which means having very high levels of triglycerides in the blood. Triglycerides are a type of fat, and having too much of them can increase the risk of heart disease and other health problems. Pegozafermin is designed to lower these triglyceride levels, which might help reduce these risks. In this clinical trial, researchers are looking at how well pegozafermin works and how safe it is for people to use over a period of 26 weeks.

What is already known about the treatment

Pegozafermin – Pegozafermin is administered through an injection, typically under the skin, and is currently being studied in a Phase 3 clinical trial to assess its effectiveness and safety for treating severe hypertriglyceridemia, a condition characterized by very high levels of triglycerides in the blood. This medication is not yet widely available in medical practice, as it is still under investigation. The main therapeutic goal of pegozafermin is to lower fasting serum triglyceride levels in patients with this condition. At the molecular level, pegozafermin works by mimicking a natural protein in the body that helps regulate fat metabolism, thereby reducing triglyceride levels. It is classified pharmacologically as a lipid-lowering agent.

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 circulates in the bloodstream, and when their levels become excessively high, it can lead to various health issues. The condition often progresses with the accumulation of fat in the liver and other tissues, which can cause inflammation and damage. Over time, severe hypertriglyceridemia can contribute to the development of pancreatitis, a painful inflammation of the pancreas. It may also be associated with other metabolic disorders, such as insulin resistance and obesity. The progression of the disease can be influenced by genetic factors, lifestyle, and dietary habits.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503576-25-00Protocol codeBIO89-100-231Estimated enrolment416 patientsSponsor89bio Inc.

sourced from the EU Clinical Trials Register and site verification

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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.

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