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

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What is this study about?

This study focuses on patients with Severe Hypertriglyceridemia (SHTG), a condition characterized by very high levels of triglycerides in the blood that puts people at high risk of developing Acute Pancreatitis. The study aims to test how well a new medication called Plozasiran works in preventing episodes of acute pancreatitis in adults with this condition.

The research will evaluate the effectiveness and safety of Plozasiran compared to placebo in people who have experienced at least two episodes of acute pancreatitis in the past. The medication will be given as a subcutaneous injection, which means it is injected under the skin using a pre-filled syringe. The study medication or placebo will be administered over a period of 48 months.

During the study, researchers will monitor how the treatment affects triglyceride levels in the blood and how well it prevents new episodes of acute pancreatitis. They will also track how the treatment impacts participants’ daily activities and overall health status. The medication being tested, Plozasiran, is designed to reduce the production of a protein called Apolipoprotein C-III, which plays a role in controlling triglyceride levels in the body.

1 Initial assessment

Your fasting triglyceride levels will be measured to confirm they are at least 1,000 mg/dL

Your blood sugar control (HbA1c) will be checked to ensure it is 9.0% or lower

Your LDL cholesterol will be verified to be 130 mg/dL or lower

2 Treatment assignment

You will be randomly assigned to receive either Plozasiran or a placebo

Neither you nor your doctor will know which treatment you are receiving

The medication will be provided in pre-filled syringes for injection under the skin

3 Treatment period

You will receive regular injections under the skin throughout the study period

You will need to maintain a stable low-fat diet during the entire study

You will continue taking your regular prescribed medications for managing blood fats

4 Monitoring

Your triglyceride levels will be checked regularly, particularly at month 3 and month 12

Your overall health status will be monitored throughout the study

Any stomach pain episodes or other health issues will be recorded

You will complete questionnaires about your health status and daily activities

5 Study duration

The study will continue until late 2029

Regular check-ups will be scheduled throughout the study period

Your participation will help evaluate how effective the medication is in preventing acute pancreatitis

Who Can Join the Study?

  • Must be at least 18 years old
  • Can be male or female, but females must not be pregnant or breastfeeding and must not plan to become pregnant during the study
  • Must have been diagnosed with severe hypertriglyceridemia (a condition with very high levels of fat in the blood)
  • Must have documented history of fasting blood fat levels of at least 880 mg/dL
  • Must have current fasting blood fat levels of at least 1,000 mg/dL during screening
  • Must have experienced at least two episodes of acute pancreatitis (sudden inflammation of the pancreas) not caused by gallstones or alcohol, with at least one episode in the past 12 months
  • Must have fasting LDL cholesterol levels of 130 mg/dL or lower during screening
  • Must have HbA1c (a measure of blood sugar control) of 9.0% or lower during screening
  • Must be willing to follow dietary advice and maintain a low-fat diet
  • Must be taking standard medications for lowering blood fats (unless documented as unable to tolerate these medications)

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to similar medications
  • Current participation in other clinical trials
  • Severe liver problems (as measured by liver function tests)
  • Severe kidney problems (as indicated by kidney function tests)
  • Uncontrolled hypertension (high blood pressure)
  • Recent heart attack or stroke (within last 6 months)
  • Active cancer or ongoing cancer treatment
  • History of acute pancreatitis (sudden inflammation of pancreas) in the past 6 months
  • Unstable medical conditions that could interfere with study participation
  • Regular use of medications that could interact with the study drug
  • Alcohol or substance abuse within the past year
  • Mental health conditions that could affect ability to follow study procedures
  • Unable to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Graz Graz Austria
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
Oslo Universitetssykehus HF Oslo Norway
Bellvitge University Hospital L'hospitalet De Llobregat Spain
“RÄ«gas Austrumu klÄ«niskā universitātes slimnÄ«ca” SIA Riga Latvia

Other Sites

Site Name City Country Status
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Medical center 4LIFE Ltd. Burgas Bulgaria
Mbal Lyulin EAD Sofia Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
University Multiprophy Hospital For Active Treatment – Plovdiv AD Plovdiv Bulgaria
Klinik Hietzing Vienna Austria
University Of Pecs Pecs Hungary
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Medical Center Teodora EOOD Ruse Bulgaria
University Of Szeged Szeged Hungary
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Privat Doktor Egeszseguegyi Szolgaltato Zrt. Budapest Hungary
Universitair Ziekenhuis Gent Gent Belgium
Medical Center Endomedical OOD Sofia Bulgaria
Saules seimos medicinos centras UAB Kaunas Lithuania
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Pauls Stradins Clinical University Hospital Riga Latvia
Mzkdosa Csxmxs Auwsh Iqb Puyuhso Ewvc Sofia Bulgaria
Kkavtel Dfq Bedbxuxzqlnu Bsqprsd Linz Austria
Kbmaikrzaob Skixiowzpw Uaa Kaunas Lithuania
Hcahgfxy Vjza dyknlcsd Barcelona Spain
Hvntxrgz Uwixxmoqqujyn du A Cfysfj A Coruna Galicia Spain
Idvvm Ppwhwlw Gnmwztx Perzmyrvyczd Pgalavln Tukums Latvia
Mrsphcc Cscxae Dzs Riga Latvia

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
30.09.2025
Belgium Belgium
Not yet recruiting
30.09.2025
Bulgaria Bulgaria
Recruiting
30.09.2025
Hungary Hungary
Recruiting
30.09.2025
Latvia Latvia
Not yet recruiting
30.09.2025
Lithuania Lithuania
Not yet recruiting
30.09.2025
Norway Norway
Not yet recruiting
30.09.2025
Spain Spain
Not yet recruiting
30.09.2025
Sweden Sweden
Recruiting
30.09.2025

Trial locations

Plozasiran is an investigational medication being studied for treating severe hypertriglyceridemia (very high levels of triglycerides in the blood) in adults who are at high risk of developing acute pancreatitis. This medication is designed to help reduce the risk of sudden inflammation of the pancreas by controlling triglyceride levels in the blood.

Investigated diseases:

Severe Hypertriglyceridemia (SHTG) – A metabolic disorder characterized by abnormally high levels of triglycerides (fat molecules) in the blood, specifically exceeding 500 mg/dL. The condition develops when the body cannot effectively break down or remove triglycerides from the bloodstream. SHTG can be inherited genetically or develop due to other health conditions, poor diet, or certain medications. The excess triglycerides can accumulate in various organs throughout the body. This condition often causes symptoms such as recurrent abdominal pain, fatty deposits under the skin, and enlargement of the liver or spleen.

Acute Pancreatitis (AP) – An inflammatory condition where the pancreas becomes suddenly inflamed. The condition occurs when digestive enzymes become activated while still inside the pancreas, causing the organ to begin digesting itself. AP typically causes intense pain in the upper abdomen, which can spread to the back. The inflammation usually develops over a short period, causing symptoms such as nausea, vomiting, and tenderness in the abdomen. The condition can be triggered by various factors, including very high blood triglyceride levels.

Trial ID:
2024-518206-40-00
Protocol code:
AROAPOC3-3011
NCT ID:
NCT06880770
Trial Phase:
Therapeutic confirmatory (Phase III)

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