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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Medical Center Hera EOOD Sofia Bulgaria
PreventaMed s.r.o. Olomouc Czechia
Hospital Universitario 12 De Octubre Madrid Spain
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Medispol s.r.o. Presov Slovakia
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
Daugavpils regionala slimnica SIA Daugavpils Latvia
Kardiologicka ambulance MUDr. Ferkl s.r.o. Horni Predmesti Czechia
Clinical Medical Research Sp. z o.o. Katowice Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
Edumed s.r.o. Nachod Czechia
Kalimat Medical Center Ltd. Sofia Bulgaria
Medizinisches Versorgungszentrum Jung GbR Deggingen Germany
Cardioinvest s.r.o. Nove Zamky Slovakia
Diamedical Medical Center 2013 Ltd. Dimitrovgrad Bulgaria
Smo Md GmbH Magdeburg Germany
Kardiovaskularne centrum s.r.o. Nove Mesto Slovakia
Medical Center Zara-Med EOOD Stara Zagora Bulgaria
UNIMED Medical Center EOOD Plovdiv Bulgaria
Coromed-Smo Kft. Pecs Hungary
Nemocnice Slany Slany Czechia
IPR Hungary Kft. Miskolc Hungary
Saules seimos medicinos centras UAB Kaunas Lithuania
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Virgen del Rocío University Hospital Sevilla Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Centre Hospitalier Saint Joseph Saint Luc Lyon France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Centre Hospitalier De La Cote Basque Bayonne France
Pratia S.A. Skorzewo Poland
Multidisciplinary Hospital For Active Treatment Haskovo AD Haskovo Bulgaria
Belvarosi Egeszseghaz Kft. Zalaegerszeg Hungary
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Pirmoji Viltis UAB Siauliai Lithuania
Medical Center Teodora EOOD Ruse Bulgaria
Infer-Med Kft. Pecs Hungary
Tatratrial s.r.o. Roznava Slovakia
Belgyogyaszati es Kardiologiai Maganrendelo Bekescsaba Hungary
Nyiro Gyula Orszagos Pszichiatriai es Addiktologiai Intezet Budapest Hungary
Indywidualna Specjalistyczna Praktyka Lekarska Włodzimierz Kuś Lodz Poland
Udztb Szinkndh Ozo Sofia Bulgaria
Klncsc Cvrf Pfnwqlpwfhc Pklxqj Intrjntflgu Kaunas Lithuania
Ieytd Pthhxwp Gctitna Pywlzwvcpxyi Pmmahxyg Tukums Latvia
Mekvhhr Civtwj Dlx Riga Latvia
Omfb Mqqstrp Cnrqpf Daugavpils Latvia
Uxjknym Dqjmyefzuwk kzfb Prague Czechia
Mowuzqbyb Ipzjfkwrrg Cpyscubi Scrkrtet Spm z oneo Warsaw Poland
Kuirwtmcatg Slrdhugefy Uqx Kaunas Lithuania
Mkfsvwr Cvsutc Deg Mxlaozyx Eqki Kyustendil Bulgaria
Alamtrdkkl Plpujbqf Hzhunbxw Dn Mpfbhtlls Marseille France
Uoertstixn Hzgxvqjxj Psrqq Shqsuwgpchn Cmxykrh Fapi Paris France
Ihjoniax Uca Kaunas Lithuania
Mztsnkj Cpierl Aazjs Iun Pgksoyv Esqa Sofia Bulgaria
Mxgwjif Crunseqpnh Dcfemjv Enlz Sofia Bulgaria
Zvlyonr Syav Axyegbeao i Dglpwu Dljgcy Wroclaw Poland
Hitroolr Ukhigecsvibfp dv A Ckjizy A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
01.10.2024
Czechia Czechia
Not recruiting
01.10.2024
France France
Not recruiting
01.10.2024
Germany Germany
Not recruiting
01.10.2024
Hungary Hungary
Not recruiting
01.10.2024
Latvia Latvia
Not recruiting
01.10.2024
Lithuania Lithuania
Not recruiting
01.10.2024
Poland Poland
Not recruiting
01.10.2024
Slovakia Slovakia
Not recruiting
01.10.2024
Spain Spain
Not recruiting
01.10.2024

Trial locations

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.

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 ID:
2023-509301-80-00
Protocol code:
AROAPOC3-3004
NCT ID:
NCT06347016
Trial Phase:
Therapeutic confirmatory (Phase III)

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