Study on Long-Term Safety and Efficacy of ARO-APOC3 for Adults with Mixed Dyslipidemia

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called ARO-APOC3 in adults with a condition known as dyslipidemia. Dyslipidemia is a medical condition where there is an abnormal amount of lipids, such as cholesterol and triglycerides, in the blood. The treatment being tested, ARO-APOC3, is a solution for injection that contains a special type of molecule designed to target and reduce a protein called apolipoprotein C-III, which is involved in lipid metabolism.

The purpose of this study is to evaluate how safe and effective ARO-APOC3 is when used over a long period. Participants in the study will receive the treatment through subcutaneous injections, which means the solution is injected under the skin. The study will monitor participants for any side effects and measure changes in various blood lipid levels, including triglycerides, non-high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol, among others.

This study is an extension of a previous trial, meaning it continues to observe participants who have already completed an earlier phase of treatment. The trial aims to provide more information on how ARO-APOC3 affects lipid levels in the blood over time and to ensure that it remains safe for long-term use. Participants will be closely monitored throughout the study to gather comprehensive data on the treatment’s impact on their health.

1 joining the study

Participation begins after completing a prior 48-week study treatment period.

Eligibility requires being an adult aged 18 or older, not pregnant or lactating, and having provided written consent.

2 treatment administration

The medication used is called ARO-APOC3, which is a solution for injection.

It is administered through a subcutaneous injection, meaning it is injected under the skin.

The treatment aims to evaluate the long-term safety and effectiveness of ARO-APOC3 in managing mixed dyslipidemia.

3 monitoring and evaluation

The primary focus is on observing any treatment-emergent adverse events (TEAEs).

Secondary evaluations include changes in various blood lipid levels, such as triglycerides, apolipoprotein C-III, non-high-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total apolipoprotein B, and low-density lipoprotein cholesterol.

4 study duration

The study is expected to conclude by September 26, 2025.

The recruitment for the study began on July 7, 2022.

Who Can Join the Study?

  • Adults who are 18 years or older can participate.
  • Participants must be nonpregnant and nonlactating (not breastfeeding) and should not plan to become pregnant during the study.
  • Participants must be able and willing to provide written informed consent before any study-specific procedures are done. This means they agree to participate and understand what the study involves.
  • Participants must have completed the 48-week study treatment period in the previous related study.

Who Cannot Join the Study?

  • Individuals with certain health conditions that might interfere with the study.
  • People who are currently taking medications that could affect the study results.
  • Participants who have had a recent major surgery or are planning to have one soon.
  • Women who are pregnant or breastfeeding.
  • Individuals with a history of allergic reactions to similar treatments.
  • People with severe liver or kidney problems.
  • Participants who are part of another clinical trial.
  • Individuals with uncontrolled high blood pressure.
  • People with certain heart conditions that are not stable.
  • Participants who have a history of substance abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Borbanya Praxis Egeszsegugyi Kft. Nyiregyhaza Hungary
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz Poland
D & A Research B.V. Sneek The Netherlands
DRC Kft. Balatonfured Hungary
Pharma 4 Trial Kft. Gyongyos Hungary
Komaromi Selye Janos Korhaz Komarom Hungary
University Of Debrecen Debrecen Hungary
Medifarma-98 Kft. Nyiregyhaza Hungary
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Ko-Med Centra Kliniczne Sp. z o.o. Lublin Poland
Praktyka Lekarska Ewa Krzyzagorska Poznan Poland
Belgyogyaszati – Kardiologiai Maganrendelo Bekescsaba Hungary
Aoqsuhsdw Ucn Amsterdam The Netherlands
Lvalfde Kypa Baja Hungary
Mqjtpqpj Sgx z otfn Oświęcim Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Hungary Hungary
Not recruiting
07.07.2022
Poland Poland
Not recruiting
07.07.2022
The Netherlands The Netherlands
Not recruiting
07.07.2022

Trial locations

ARO-APOC3 is a medication being studied for its potential to help manage dyslipidemia, a condition characterized by abnormal levels of lipids in the blood. This medication is designed to target and reduce the production of a specific protein involved in lipid metabolism, which may help lower cholesterol and triglyceride levels. The trial aims to assess the long-term safety and effectiveness of this treatment in adults with mixed dyslipidemia.

Mixed Dyslipidemia – Mixed dyslipidemia is a condition characterized by abnormal levels of lipids in the blood, including high levels of low-density lipoprotein (LDL) cholesterol, triglycerides, and low levels of high-density lipoprotein (HDL) cholesterol. This imbalance can lead to the buildup of fatty deposits in the arteries, increasing the risk of cardiovascular diseases. The condition often progresses silently, with no obvious symptoms, until significant arterial damage occurs. Over time, the persistent imbalance in lipid levels can contribute to the development of atherosclerosis, where arteries become narrowed and hardened. This can eventually lead to complications such as heart attacks or strokes if not managed. Mixed dyslipidemia is often associated with lifestyle factors, genetic predisposition, or other underlying health conditions.

Trial ID:
2024-511331-96-00
Protocol code:
AROAPOC3-2003
NCT ID:
NCT05413135
Trial Phase:
Therapeutic exploratory (Phase II)

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