RecruitingPHASE3INTERVENTIONAL

Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis

This research study is looking for adults with a condition called severe hypertriglyceridemia, which means they have very high levels of a type of fat called triglycerides in their blood. These high levels can lead to painful inflammation of the pancreas, called pancreatitis. The study aims to see if a new medicine, plozasiran, can safely and effectively reduce these triglyceride levels and prevent pancreatitis attacks. Participants, who will have experienced pancreatitis before, will receive either plozasiran or a dummy medicine (placebo) by injection every three months. Everyone will also continue to follow a low-fat diet and take their usual medicines. After the initial part of the study, all participants will have the option to receive plozasiran for a longer period.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Arrowhead Pharmaceuticals

Enrolment target

288

Start

24 Apr 2025

Estimated completion

01 Jun 2029

Severe Hypertriglyceridemia

What is this study about?

This study is about a new medicine called plozasiran. We're testing it in adults who have a health problem called severe hypertriglyceridemia. This means they have very high levels of fats called triglycerides in their blood. For some people, these high triglyceride levels can lead to a serious and painful condition called acute pancreatitis, which is inflammation of the pancreas, an organ that helps with digestion.

The main goals of this study are to find out if plozasiran is safe to use and if it can effectively lower triglyceride levels. Importantly, we also want to see if it can help reduce the chances of having another attack of acute pancreatitis. This is really important because people who have had severe pancreatitis in the past due to high triglycerides are at higher risk of it happening again.

We're testing plozasiran against a 'placebo' – which is a dummy medicine that looks just like plozasiran but doesn't contain the active drug. This helps us to fairly compare the effects of the new medicine. Everyone taking part will get regular care and advice, including guidance on a low-fat diet, throughout the study.

Key takeaways

The study tests a new medicine for very high triglycerides.
It aims to prevent pancreatitis attacks.
Participants will get either the study medicine or a dummy medicine.
Injections are given every three months.
You'll continue your low-fat diet and usual medicines.
All participants may get the active medicine after the first part.

Who may be eligible?

To join this study, you need to be an adult (18 or older) and have severe hypertriglyceridemia, meaning your triglyceride levels have been very high in the past. You should also have had at least one attack of acute pancreatitis in the last five years, which wasn't caused by something other than high triglycerides.

There are also some other important things that decide if you can join. For example, your other cholesterol levels and blood sugar (HbA1c) need to be within a certain range. You also need to be willing to follow a low-fat diet and continue with your current medicines for cholesterol and triglycerides.

Some things would mean you can't join. For instance, if you've had pancreatitis very recently (in the last month), or if you've recently had major heart problems or surgery. Also, if you're planning any weight-loss surgery or certain heart procedures during the study, or if your BMI is very high, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with very high triglycerides in the past?
Have you had acute pancreatitis before that wasn't due to other causes?
Can you commit to following a low-fat diet?
Do you take medicines for cholesterol or triglycerides already?
Have you avoided major heart problems or surgery very recently?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to receive either the study medicine, plozasiran, or a placebo (dummy medicine). You won't know which one you're getting, and neither will your study doctor. Both are given as an injection under the skin every three months. You'll continue to follow a low-fat diet and take your usual prescribed medicines throughout the study.

Regular visits to the study clinic will be needed for health checks, blood tests to measure your triglyceride levels and other markers, and to make sure you're feeling well. The first part of the study involves receiving the study medicine for a certain period. After this, or if you experience a pancreatitis event, you will have the option to join an 'Open-Label Extension' part of the study. In this extension, everyone will receive plozasiran for another 12 months. The total duration of your participation could be over a year, depending on when you join the open-label part.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A possible benefit of joining this study is that plozasiran might help lower your triglyceride levels and reduce your risk of pancreatitis. However, since this is a new medicine, we don't yet know if it will definitely help you, or if it has any side effects that we are not yet aware of. You might receive the placebo, which means you wouldn't get the active medicine during the first part of the study. All procedures and medicines have potential risks, including blood tests and injections which can cause discomfort or bruising. We will carefully monitor your health throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (102)

Research Site
Verified postcode
Los Angeles, United States· Recruiting
Clinical Research Site 4
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Santa Clarita, United States· Recruiting
Research Site
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New Haven, United States· Recruiting
Clinical Research Site 6
Verified postcode
Springfield, United States· Recruiting
Research Site
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Indianapolis, United States· Recruiting
Research Site
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Kansas City, United States· Recruiting
Research Site
Verified postcode
Ann Arbor, United States· Recruiting
Research Site
Verified postcode
St Louis, United States· Recruiting
Clinical Research Site 5
Verified postcode
North Platte, United States· Recruiting
Clinical Research Site 3
Verified postcode
Greensboro, United States· Recruiting
Research Site
Verified postcode
Wilmington, United States· Recruiting
Clinical Research Site 7
Verified postcode
Philadelphia, United States· Recruiting

Common questions

What is severe hypertriglyceridemia (SHTG)?

It's when you have very high levels of a type of fat called triglycerides in your blood. This can lead to serious health problems like pancreatitis.

What is acute pancreatitis?

It's a sudden inflammation of the pancreas, an organ near your stomach. It can be very painful and is sometimes caused by very high triglyceride levels.

What is a placebo?

A placebo is a 'dummy' medicine that looks just like the real study medicine but doesn't contain any active drug. It helps us compare the real medicine's effects fairly.

How is the study medicine given?

The study medicine (plozasiran or placebo) is given as an injection under the skin, once every three months.

Can I continue my regular medicines?

Yes, you should continue taking your usual prescribed medicines for cholesterol and triglycerides, along with following a low-fat diet, throughout the study.

How to find out more

Medical Monitor

plozasiran@arrowheadpharma.com 626-304-3400 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.