Study of Plozasiran 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 a new medication designed to help reduce these high triglyceride levels. Plozasiran is a synthetic compound that targets specific molecules in the body to lower triglyceride levels.

The purpose of this study is to assess how effective and safe Plozasiran is in reducing fasting triglyceride levels in adults with severe hypertriglyceridemia. Participants in the study will receive either Plozasiran or a placebo, which is a substance with no active medication. The study will last for about 12 months, during which participants will receive regular injections and have their triglyceride levels monitored at various points to see how they change over time.

Throughout the study, participants will be closely monitored for any changes in their health and any side effects they might experience. The goal is to determine if Plozasiran can significantly lower triglyceride levels compared to the placebo, and to see if it helps more participants reach healthier triglyceride levels. This research could lead to a new treatment option for people with severe hypertriglyceridemia, potentially improving their health and reducing the risk of complications associated with high triglyceride levels.

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.

Participants are required to follow dietary counseling and maintain a stable low-fat diet.

2 initial assessment

An initial assessment is conducted to establish baseline fasting triglyceride levels.

This involves two separate visits, at least 7 days apart, to ensure accurate baseline measurements.

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 route of administration is subcutaneous, meaning the injection is given under the skin.

4 ongoing monitoring

Participants are monitored regularly to assess the efficacy and safety of the treatment.

Fasting triglyceride levels are measured at various intervals, including months 10 and 12.

The primary goal is to observe the percent change in fasting triglyceride levels from baseline to month 12.

5 evaluation of outcomes

The study evaluates the proportion of participants achieving specific triglyceride level targets at months 10 and 12.

Secondary outcomes include the rate of abdominal clinical events and the achievement of lower triglyceride levels.

6 completion of study

The study is expected to conclude by October 2026.

Final assessments are conducted to determine the overall efficacy and safety of the treatment.

Who Can Join the Study?

  • Must be a male or a non-pregnant, non-lactating female who is 18 years or older 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 medical history showing fasting triglyceride (TG) levels of 500 mg/dL or higher.
  • During the screening period, must have an average fasting TG level of 500 mg/dL or higher, measured at two separate visits that are at least 7 days apart but no more than 17 days apart.
  • Must have fasting LDL-C (low-density lipoprotein cholesterol) levels of 130 mg/dL or lower at screening.
  • Must have a screening HbA1c (a measure of blood sugar levels over time) of 8.5% or lower.
  • 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 unable to tolerate them as determined by the study doctor.

Who Cannot Join the Study?

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication.
  • Patients who are unable to follow the study procedures.
  • Patients with a history of substance abuse.
  • Patients with certain heart conditions.
  • Patients with uncontrolled diabetes.
  • Patients with liver disease.
  • Patients with kidney disease.
  • Patients who are taking medications that might interfere with the study.
  • Patients with a history of cancer within the last five years.
  • Patients with a history of mental health disorders that are not well controlled.
  • Patients who have had a major surgery recently.
  • Patients with a history of blood disorders.
  • Patients with a history of autoimmune diseases.
  • Patients with a history of infections that are not well controlled.
  • Patients with a history of gastrointestinal disorders.
  • Patients with a history of lung diseases.
  • Patients with a history of neurological disorders.

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
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
Centrul Medical Unirea S.R.L. Brasov Romania
Belvaros-Lipotvaros Egeszseguegyi Szolgalat Budapest Hungary
Alian s.r.o. Bardejov Slovakia
Clinica Medicala Data Plus S.R.L. Bucharest Romania
Medicali’s S.R.L. Timisoara Romania
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz Poland
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Medical group Kosice s.r.o. Kosice Slovakia
Pneumocare Namur Belgium
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice Krapinske Toplice Croatia
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Cardio D&R s.r.o. Kosice Kosice Slovakia
Medivasa s.r.o. Zilina Slovakia
Sedimed Sp. z o.o. Wroclaw Poland
Medical center 4LIFE Ltd. Burgas Bulgaria
Mbal Lyulin EAD Sofia Bulgaria
Diamed Obesity S.R.L. Galati Romania
Angiocare S.R.L. Cluj Napoca Romania
Hospital Quironsalud Barcelona Barcelona Spain
MBAL Sveta Karidad EAD Plovdiv Bulgaria
Medical Plus s.r.o. Uherske Hradiste Czechia
Medif Thuin Belgium
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
KBC Zagreb Zagreb Croatia
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
Clinexpert Kft. Budapest Hungary
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Opca Bolnica Zadar Zadar Croatia
Medical Center Rodopimed EOOD Kirdzhali Bulgaria
Opca Bolnica Karlovac Karlovac Croatia
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Jessa Ziekenhuis Hasselt Belgium
Pratia S.A. Skorzewo Poland
Cliniq s.r.o. Bratislava Slovakia
Poliklinika Solmed d.o.o. Zagreb Croatia
Universita Degli Studi Di Brescia Brescia Italy
Kardiocentrum Nitra s.r.o. Nitra Slovakia
Krajska zdravotni a.s. Teplice Czechia
Medical Center Teodora EOOD Ruse Bulgaria
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Fakultni Thomayerova nemocnice Prague Czechia
University Of Szeged Szeged Hungary
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Privat Doktor Egeszseguegyi Szolgaltato Zrt. Budapest Hungary
Centrum Medyczne Serafin med Żarów Poland
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Mxisfcz Ccepfe Mmjruysvrmc Lojc Sofia Bulgaria
Itqqobwbj Fll Ccknuhot Aiy Exrtgissmtoj Mrqceyrp Prague Czechia
Efhuvrx Mechelen Belgium
Mrtb Muougaa sqadbz Moldava Nad Bodvou Slovakia
Dawljq sdagn s riqe Moravska Ostrava A Privoz Czechia
Dsncs Bsbfbkpp Singrs Alba Iulia Romania
Svfcynfg Jxcpudkd Dv Uafqqwp Dnos Deva Romania
Cwk Dys Bcsjodnuh Mxookmw Mthhxqrjz Ploiesti Romania
Nmoifikmuxhj Zxvwby Omkwmw Zjnwtoovjj &yrymqfvnfwnfd Ocdmzrbhzejyx Katowice Poland
Knoyllpcvzhqj srxqht Banska Bystrica Slovakia
Ddv Lax Cyuaxv Wetteren Belgium
Kjoqilhboxc Vpxynkqfr suedqc Prague Czechia
Apaafnc Uuubx Sgmdbzncv Lfnvon Do Bwckypy Bologna Italy
Mtefbba Cgiccu Mlnisdcale Pphuat Odh Pleven Bulgaria
Hqbujuwz Vdvh drsytrro Barcelona Spain
Ckugsoxa Hqtvkzml Dmgjnxk Zagreb Croatia
Uau Msekcqv Thvyjf Kuqv Budapest Hungary
Kfjuibqaz Spgldci Szkrmojssarwbjg id Jgyq Pocao Iw Cracow Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.10.2024
Bulgaria Bulgaria
Not recruiting
01.10.2024
Croatia Croatia
Not recruiting
01.10.2024
Czechia Czechia
Not recruiting
01.10.2024
Hungary Hungary
Not recruiting
01.10.2024
Italy Italy
Not recruiting
01.10.2024
Poland Poland
Not recruiting
01.10.2024
Romania Romania
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. Triglycerides are a type of fat found in your blood, and having too much can increase the risk of heart disease. This study is focused on adults with severe hypertriglyceridemia, which means they have very high levels of triglycerides. The goal of using Plozasiran in this trial is to see if it can effectively reduce these levels and improve the patients’ health.

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 their levels become too high, it can lead to health problems. This condition can cause symptoms such as abdominal pain and may increase the risk of developing pancreatitis. Over time, the elevated triglyceride levels can contribute to the development of cardiovascular diseases. The progression of severe hypertriglyceridemia involves persistent high triglyceride levels, which can be influenced by genetic factors, lifestyle, and other health conditions. Managing triglyceride levels is crucial to prevent complications associated with this condition.

Trial ID:
2023-509300-14-00
Protocol code:
AROAPOC3-3003
NCT ID:
NCT06347003
Trial Phase:
Therapeutic confirmatory (Phase III)

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