Study to Evaluate Plozasiran for Adults with High Triglycerides

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What is this study about?

This clinical trial is focused on studying Hypertriglyceridemia, a condition characterized by high levels of triglycerides in the blood, which can increase the risk of heart disease. The study will evaluate a treatment called Plozasiran, which is designed to help reduce these triglyceride levels. The treatment involves a solution for injection known as ARO-APOC3 PFS, which contains a synthetic compound that targets specific molecules in the body to lower triglyceride levels.

The purpose of the study is to assess how effective and safe Plozasiran is in reducing fasting triglyceride levels in adults with Hypertriglyceridemia. Participants in the study will receive either the Plozasiran injection or a placebo. The study will last for about 12 months, during which participants will have regular check-ups to monitor their triglyceride levels and overall health.

This study is conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This approach helps ensure the results are unbiased. The main goal is to see if Plozasiran can significantly lower triglyceride levels compared to the placebo, and to determine how many participants achieve a healthy triglyceride level by the end of the study.

1 initial visit

The initial visit involves a comprehensive health assessment to confirm eligibility for the study. This includes verifying age, medical history, and current health status.

Blood tests are conducted to measure fasting triglyceride (TG) levels, which must be between 150 mg/dL and 499 mg/dL. Fasting low-density lipoprotein cholesterol (LDL-C) levels must be below 130 mg/dL, and HbA1c levels must be below 8.5%.

2 screening period

During the screening period, fasting TG levels are measured at two separate visits, at least 7 days apart and no more than 17 days apart, to confirm eligibility.

Participants must agree to follow diet counseling and maintain a stable low-fat diet. They should also be on standard lipid-lowering medications unless they are intolerant.

3 randomization and treatment initiation

Participants are randomly assigned to receive either the plozasiran injection or a placebo. The medication is administered as a subcutaneous injection using a pre-filled syringe.

The treatment aims to reduce fasting serum TG levels, with the primary goal being a percent change from baseline to Month 12.

4 treatment phase

Participants receive regular injections throughout the study period. The frequency and dosage are determined by the study protocol.

Regular monitoring of fasting TG levels occurs, with key assessments at Month 10 and Month 12 to evaluate the effectiveness of the treatment compared to the placebo.

5 follow-up visits

Follow-up visits are scheduled to monitor health status and any changes in fasting TG levels. These visits help assess the long-term impact of the treatment.

Participants are evaluated for any side effects or adverse reactions to the treatment.

6 study completion

The study concludes with a final assessment of fasting TG levels and overall health.

Participants receive information about the study results and any potential next steps regarding their health management.

Who Can Join the Study?

Participants can be males or females who are not pregnant and do not plan to become pregnant. They must be at least 18 years old at the time of screening.
Participants must have an established diagnosis of hypertriglyceridemia (HTG), which means they have high levels of triglycerides in their blood. They should have a documented history showing their fasting triglyceride (TG) levels are between 150 mg/dL (1.69 mmol/L) and 499 mg/dL (5.64 mmol/L).
During the screening period, participants must have their fasting TG levels measured twice, at two separate visits, at least 7 days apart but no more than 17 days apart. The levels should be between 150 mg/dL (1.69 mmol/L) and 499 mg/dL (5.64 mmol/L).
Participants must have a fasting LDL-C level (a type of cholesterol) of 130 mg/dL (3.37 mmol/L) or lower at screening.
Participants must have a HbA1c level (a measure of blood sugar control over time) of 8.5% or lower at screening.
Participants must be willing to follow diet counseling and maintain a stable low-fat diet.
Participants must be on standard lipid-lowering medications as per local guidelines, unless they are documented as intolerant to these medications, as determined by the study investigator.

Who Cannot Join the Study?

Individuals with certain medical conditions that are not compatible with the study.
People who are currently taking medications that might interfere with the study treatment.
Participants who have had a recent surgery or are planning to have surgery during the study period.
Individuals with a history of allergic reactions to similar treatments.
Pregnant or breastfeeding women.
People with severe liver or kidney problems.
Participants who are unable to follow the study procedures or attend scheduled visits.
Individuals with certain heart conditions that could be affected by the study treatment.
People who have participated in another clinical trial recently.
Individuals with a history of substance abuse or alcohol dependency.

Where you can join this trial?

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Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	15.10.2024
Czechia	Not recruiting	15.10.2024
France	Not recruiting	15.10.2024
Germany	Not recruiting	15.10.2024
Hungary	Not recruiting	15.10.2024
Italy	Not recruiting	15.10.2024
Poland	Not recruiting	15.10.2024
Slovakia	Not recruiting	15.10.2024
Spain	Not recruiting	15.10.2024

Trial locations

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 high levels can increase the risk of heart disease. This study is testing how well plozasiran works in reducing these levels in adults with hypertriglyceridemia, which is a condition characterized by elevated triglyceride levels.

Hypertriglyceridemia – This condition is characterized by elevated levels of triglycerides in the blood. Triglycerides are a type of fat that the body uses for energy, but high levels can lead to health issues. The condition often progresses without noticeable symptoms, making it difficult to detect without blood tests. Over time, high triglyceride levels can contribute to the development of other health problems, such as pancreatitis or cardiovascular diseases. It is often associated with other conditions like obesity, diabetes, and metabolic syndrome. Lifestyle factors, such as diet and physical activity, can influence triglyceride levels.

Trial ID:

2023-509302-30-00

Protocol code:

AROAPOC3-3009

NCT ID:

NCT06347133

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study to Evaluate Plozasiran for Adults with High Triglycerides

What is this study about?

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Who Cannot Join the Study?