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Hypertriglyceridaemia – Trials in Disease

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Ongoing Clinical Trials for Hypertriglyceridaemia

Currently, there are 9 ongoing clinical trials investigating new treatments for hypertriglyceridaemia, a condition characterised by elevated levels of triglycerides in the blood. These studies are being conducted across multiple European countries and are primarily testing medications called plozasiran, olezarsen, and pegozafermin, which aim to reduce triglyceride levels and prevent serious complications such as acute pancreatitis and cardiovascular disease.

Clinical trial locations

Long-Term Safety Study of Plozasiran for Adults with High Triglycerides

This long-term extension study is evaluating the safety and effectiveness of plozasiran in adults with elevated triglyceride levels. The trial is open to participants who have successfully completed a previous plozasiran study with an acceptable safety profile.

Main inclusion criteria: Participants must be adults (male or non-pregnant, non-lactating females) who have completed all required visits in a previous related study. Women of childbearing potential must agree to use highly effective birth control methods during the study and for at least 90 days after the last dose. All participants must agree not to donate sperm or eggs during this period. Those using hormonal birth control should have been on stable medication for more than one menstrual cycle before joining.

Main exclusion criteria: Individuals with a history of allergic reactions to plozasiran cannot participate. The study excludes those currently taking medications that might interfere with the study drug, as well as patients with severe liver disease or uncontrolled diabetes. Pregnant or breastfeeding women, those with substance abuse history in the past year, and individuals who participated in another clinical trial within the last 30 days are also excluded.

Trial focus: The study monitors participants receiving regular injections of plozasiran through regular follow-up visits that include blood tests and other assessments. The healthcare team tracks changes in triglyceride levels and cholesterol levels over time, carefully monitoring for any side effects. The trial aims to provide comprehensive information on the long-term safety and effectiveness of plozasiran for managing elevated triglyceride levels.

Investigational drug: Plozasiran is administered as a subcutaneous injection targeting apolipoprotein C-III, a protein that plays a role in controlling triglyceride levels. The medication is designed to reduce the risk of heart disease and related health issues by lowering these fat levels in the blood.

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

This study focuses on preventing acute pancreatitis in adults with severe hypertriglyceridemia who have experienced at least two episodes of this painful pancreatic inflammation in the past. The trial will run until late 2029 and aims to evaluate whether plozasiran can effectively prevent new episodes.

Main inclusion criteria: Participants must be at least 18 years old with documented severe hypertriglyceridemia, showing fasting blood fat levels of at least 880 mg/dL historically and at least 1,000 mg/dL during screening. They must have experienced at least two episodes of acute pancreatitis not caused by gallstones or alcohol, with at least one episode in the past 12 months. Participants need fasting LDL cholesterol levels of 130 mg/dL or lower, HbA1c of 9.0% or lower, and must be willing to maintain a low-fat diet.

Main exclusion criteria: The study excludes individuals under 18 or over 75 years old, pregnant or breastfeeding women, and those with severe liver or kidney problems. People with recent heart attack or stroke (within 6 months), active cancer, acute pancreatitis in the past 6 months, or alcohol/substance abuse within the past year cannot participate. Those with uncontrolled hypertension, unstable medical conditions, or mental health conditions affecting study participation are also excluded.

Trial focus: Participants receive either plozasiran or placebo injections regularly while maintaining a stable low-fat diet and continuing prescribed medications for managing blood fats. The study monitors triglyceride levels regularly, particularly at months 3 and 12, along with overall health status and any episodes of stomach pain. Participants complete questionnaires about their health and daily activities throughout the study period.

Investigational drug: Plozasiran is a small interfering RNA (siRNA) therapeutic administered through subcutaneous injection using pre-filled syringes. It works at the molecular level by reducing the production of Apolipoprotein C-III, thereby lowering triglyceride levels and potentially preventing acute pancreatitis in high-risk patients.

Study of ISIS 678354 for Patients with Severe Hypertriglyceridemia

This open-label extension study evaluates the long-term safety and tolerability of olezarsen in patients with severe hypertriglyceridemia over a period of up to 66 weeks. The trial follows participants who have completed previous related studies successfully.

Main inclusion criteria: Participants must have successfully completed either the ISIS 678354-CS5 or ISIS 678354-CS6 study with a good safety record as judged by the study doctor. They must be on a stable treatment plan for lowering blood fats that follows standard medical guidelines in their area. The study is open to both male and female participants, including those from vulnerable groups who might need extra care or protection.

Main exclusion criteria: Individuals with other serious health conditions that could interfere with the study, pregnant or breastfeeding women, and those who participated in another clinical trial recently cannot join. The study also excludes people with allergies to similar medications, liver or kidney problems, uncontrolled diabetes or high blood pressure, and those taking medications that could interfere with olezarsen. Individuals with a history of drug or alcohol abuse, heart disease, or stroke are also excluded.

Trial focus: Participants receive regular olezarsen injections under the skin using the YpsoMate automated injection system while continuing their stable lipid-lowering medication regimen. The study monitors changes in health through laboratory values, regular check-ups, and careful observation for any adverse events. Healthcare providers track the use of any additional medications needed during the trial period.

Investigational drug: Olezarsen is an antisense oligonucleotide medication administered through subcutaneous injection. It targets specific molecules in the body to reduce triglyceride levels, helping manage severe hypertriglyceridemia and reduce associated health risks.

Study of Olezarsen (ISIS 678354) for Patients with High Triglycerides and Heart Disease or Severe High Triglycerides

This double-blind, placebo-controlled study lasting about 53 weeks evaluates olezarsen in individuals with hypertriglyceridemia combined with atherosclerotic cardiovascular disease, or those with severe hypertriglyceridemia alone.

Main inclusion criteria: Participants must have hypertriglyceridemia with fasting triglyceride levels between 150-500 mg/dL, or severe hypertriglyceridemia with levels of 500 mg/dL or higher. They must have a clinical diagnosis of atherosclerotic cardiovascular disease (narrowed or blocked arteries due to cholesterol and fat buildup) or be at increased risk for this condition. Participants should be on standard lipid-lowering medications according to local guidelines, optimized and stable for at least 4 weeks before the study begins.

Main exclusion criteria: The study focuses specifically on patients with hypertriglyceridemia, cardiovascular diseases, and atherosclerosis, so detailed exclusion criteria were not fully specified in the available information.

Trial focus: After initial eligibility confirmation and randomization, participants receive either olezarsen or placebo through subcutaneous injection according to the study protocol. Regular follow-up visits include physical examinations and laboratory tests to monitor safety and measure triglyceride changes. A detailed midpoint evaluation at week 25 assesses the percent change in fasting triglyceride levels, with a final comprehensive evaluation at week 53 comparing results to baseline measurements.

Investigational drug: Olezarsen is an antisense oligonucleotide administered through injections under the skin. Currently in Phase 3 clinical trials, it targets specific molecules to reduce triglyceride levels, potentially helping manage or prevent heart-related health issues in people with elevated blood fats and cardiovascular disease risk.

Study of Plozasiran for Adults with Severe Hypertriglyceridemia

This study, expected to conclude by October 2026, evaluates plozasiran’s effectiveness and safety in reducing fasting triglyceride levels in adults with severe hypertriglyceridemia over a 12-month period.

Main inclusion criteria: Participants must be at least 18 years old with confirmed severe hypertriglyceridemia diagnosis, showing historical fasting triglyceride levels of at least 500 mg/dL. During screening, they must have average fasting triglyceride levels of 500 mg/dL or higher measured at two separate visits at least 7 days apart. Additional requirements include fasting LDL cholesterol of 130 mg/dL or lower, screening HbA1c of 8.5% or lower, and willingness to follow dietary counseling and maintain a stable low-fat diet. Participants should be taking standard lipid-lowering medications unless intolerant.

Main exclusion criteria: The study excludes pregnant or breastfeeding women, those who participated in another clinical trial recently, and individuals with allergies to the study medication. People unable to follow study procedures, those with substance abuse history, certain heart conditions, uncontrolled diabetes, liver disease, or kidney disease cannot participate. Also excluded are patients taking interfering medications, those with cancer history within five years, uncontrolled mental health disorders, recent major surgery, or histories of blood disorders, autoimmune diseases, uncontrolled infections, gastrointestinal disorders, lung diseases, or neurological disorders.

Trial focus: After establishing baseline fasting triglyceride levels through two separate visits, participants receive either plozasiran or placebo injections subcutaneously. Regular monitoring assesses treatment efficacy and safety, with fasting triglyceride measurements at various intervals including months 10 and 12. The primary goal is observing the percent change from baseline to month 12, evaluating the proportion of participants achieving specific triglyceride targets and monitoring the rate of abdominal clinical events.

Investigational drug: Plozasiran is a lipid-lowering agent administered as a subcutaneous injection using pre-filled syringes. Currently in Phase 3 studies, it targets specific molecules in the body to reduce triglyceride levels and improve lipid profiles in individuals with severe hypertriglyceridemia.

Study on Plozasiran and ARO-APOC3 for Adults with Severe Hypertriglyceridemia

This 12-month study, expected to conclude by October 2026, investigates plozasiran’s effectiveness at reducing triglyceride levels in adults with severe hypertriglyceridemia compared to placebo.

Main inclusion criteria: Participants must be at least 18 years old (male or non-pregnant, non-lactating female) with confirmed severe hypertriglyceridemia diagnosis and documented historical fasting triglyceride levels of at least 500 mg/dL. During screening, average fasting triglyceride levels must be at least 500 mg/dL measured at two separate visits 7-17 days apart. Additional requirements include fasting LDL cholesterol of 130 mg/dL or lower, screening HbA1c of 8.5% or lower, and willingness to follow dietary counseling and maintain a stable low-fat diet while taking standard lipid-lowering medications unless documented as intolerant.

Main exclusion criteria: The study excludes individuals with other serious interfering health conditions, pregnant or breastfeeding women, recent clinical trial participants, those unable to give informed consent, people with drug or alcohol abuse history, those allergic to the study medication or its ingredients, individuals who had recent major surgery or plan surgery during the study, people with unstable mental health conditions, certain uncontrolled heart conditions, and those with severe liver or kidney disease.

Trial focus: After initial eligibility confirmation and baseline assessment, participants receive either plozasiran injection or placebo subcutaneously using pre-filled syringes while following dietary counseling. Regular monitoring of fasting triglyceride levels occurs throughout the study, with participants attending scheduled visits to track changes in triglyceride levels and overall health. The primary goal is measuring the percent change in fasting triglyceride levels from baseline to Month 12, with secondary evaluations including the proportion achieving specific targets and the rate of abdominal clinical events.

Investigational drug: Plozasiran is a lipid-lowering agent administered as a subcutaneous injection. Currently in Phase 3 clinical trials, it targets and reduces the production of specific proteins involved in triglyceride metabolism, thereby lowering triglyceride levels and improving lipid profiles in affected individuals.

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

This 52-week study evaluates pegozafermin’s effects on triglyceride levels in people with severe hypertriglyceridemia, with the main focus on changes at the 26-week mark. Participants also take simvastatin for cholesterol management.

Main inclusion criteria: Participants must be at least 22 years old and willing to maintain stable medication, eating, and exercise habits during the study. They must be on stable background lipid-modifying therapy for at least 4 weeks before the study, meaning taking medication to help manage cholesterol and fat levels in the blood.

Main exclusion criteria: The study excludes patients with severe hypertriglyceridemia outside the study’s specifications, those not within the specified age range, and individuals considered part of vulnerable populations who might need special protection or care.

Trial focus: After an initial visit confirming eligibility and a medication stabilization period, participants receive pegozafermin administered subcutaneously for 26 weeks while maintaining a stable background of simvastatin (10 mg oral tablets). Regular assessments monitor changes in triglyceride levels and other cholesterol-related measures at specified intervals, including weeks 26 and 52. The study also evaluates changes in liver fat content using MRI scans.

Investigational drug: Pegozafermin is a lipid-lowering agent administered through subcutaneous injection. Currently in Phase 3 clinical trials, it works at the molecular level by mimicking a natural protein in the body that helps regulate fat metabolism, thereby reducing triglyceride levels and managing severe hypertriglyceridemia.

Study on the Safety of A24110He for Patients with Type 2 Diabetes and High Triglycerides

This Phase 2 trial, conducted exclusively in Sweden, studies the safety and local tolerability of A24110He in people with type 2 diabetes and elevated triglyceride levels. Participants receive four weekly doses administered subcutaneously.

Main inclusion criteria: Participants must be 18-75 years old with a BMI less than 38 kg/m² and weight at least 56 kg. They need documented triglyceride levels of at least 2.5 mmol/L with stable lipid-lowering medication for 3 months before the trial, and fasting triglyceride levels of at least 2.5 mmol/L at the first visit. Participants must have type 2 diabetes diagnosed for at least 6 months with stable blood sugar-lowering medication for 3 months. They must provide written consent, have access to blood sugar monitoring equipment, safe blood sugar control, suitable veins for blood tests, and willingness to follow trial procedures. Women of childbearing potential must have negative pregnancy tests and use effective birth control, while sexually active non-sterile men must ensure their partners use birth control or avoid sexual intercourse during the trial and for 180 days after the last dose.

Main exclusion criteria: The study excludes those without type 2 diabetes with moderate to severe hypertriglyceridemia, individuals outside the specified age range, those not matching the clinical trial group criteria, and people considered part of vulnerable populations.

Trial focus: After initial assessment confirming eligibility and establishing baseline measurements including fasting plasma glucose and triglyceride levels, participants receive the first dose under controlled conditions to monitor immediate reactions. Throughout the four weekly administrations, regular monitoring includes vital signs checks, laboratory tests, and local tolerability assessments. Participants report any adverse events, and a comprehensive final assessment evaluates overall health effects of the treatment.

Investigational drug: A24110He is an investigational drug administered through weekly subcutaneous injections. Currently in Phase 2 clinical trials, it targets specific pathways to help regulate blood sugar and lipid levels in people with type 2 diabetes and moderate to severe hypertriglyceridemia.

Study to Evaluate Plozasiran for Adults with High Triglycerides

This double-blind, placebo-controlled study lasting about 12 months assesses plozasiran’s effectiveness and safety in reducing fasting triglyceride levels in adults with hypertriglyceridemia, with neither participants nor researchers knowing who receives the actual treatment or placebo.

Main inclusion criteria: Participants must be at least 18 years old with established hypertriglyceridemia diagnosis showing documented historical fasting triglyceride levels between 150-499 mg/dL. During screening, fasting triglyceride levels must measure between 150-499 mg/dL at two separate visits at least 7 days apart but no more than 17 days apart. Additional requirements include fasting LDL cholesterol of 130 mg/dL or lower, HbA1c of 8.5% or lower at screening, and willingness to follow diet counseling and maintain a stable low-fat diet. Participants must be on standard lipid-lowering medications per local guidelines unless documented as intolerant.

Main exclusion criteria: The study excludes individuals with certain incompatible medical conditions, those taking interfering medications, people who had recent surgery or plan surgery during the study, those with allergies to similar treatments, pregnant or breastfeeding women, people with severe liver or kidney problems, those unable to follow study procedures or attend scheduled visits, individuals with certain heart conditions that could be affected by the treatment, recent clinical trial participants, and those with substance abuse or alcohol dependency history.

Trial focus: After comprehensive health assessment confirming eligibility and establishing baseline triglyceride measurements, participants are randomly assigned to receive either plozasiran or placebo injections subcutaneously using pre-filled syringes. Regular monitoring of fasting triglyceride levels occurs throughout the treatment phase, with key assessments at Month 10 and Month 12 evaluating treatment effectiveness. Follow-up visits monitor health status and any side effects, with the study concluding with a final assessment providing participants with information about results and potential next steps for health management.

Investigational drug: Plozasiran is an RNA interference therapeutic administered as a subcutaneous injection. Currently in Phase 3 clinical trials, it works by targeting and reducing the production of specific proteins involved in triglyceride synthesis, thereby lowering triglyceride levels in the blood and reducing the risk of heart disease in adults with hypertriglyceridemia.

Summary

The nine ongoing clinical trials for hypertriglyceridaemia represent a significant research effort across Europe, with studies taking place in 20 countries. The trials show a clear geographic concentration in Central and Eastern European countries, particularly Bulgaria, Poland, and Czechia, each hosting multiple studies. This widespread distribution suggests strong research infrastructure and clinical expertise in these regions for managing lipid disorders.

A notable pattern emerges in the investigational treatments being tested. Plozasiran dominates the research landscape, appearing in six of the nine trials, indicating substantial pharmaceutical interest in this RNA interference therapeutic. Olezarsen appears in two studies, while pegozafermin and A24110He are each being tested in single trials. This focus on a limited number of novel mechanisms suggests researchers are exploring potentially transformative approaches to managing this condition.

The trials address different severity levels and patient populations. Several studies focus specifically on severe hypertriglyceridaemia with very high triglyceride levels (500 mg/dL or above), while others target moderate elevation (150-499 mg/dL). One particularly important trial aims to prevent acute pancreatitis in patients with severe hypertriglyceridaemia who have already experienced this serious complication. Another study specifically addresses patients with both type 2 diabetes and elevated triglycerides, recognizing the common co-occurrence of these conditions.

Most trials are in Phase 3, the final stage before potential regulatory approval, suggesting these treatments may become available in clinical practice within the next few years if results prove favourable. The long-term safety studies extending up to 66 weeks demonstrate commitment to understanding not just short-term effects but also the sustained safety and effectiveness of these novel therapies.

Ongoing Clinical Trials on Hypertriglyceridaemia

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

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    Austria Belgium Bulgaria Hungary Latvia Lithuania +3

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