Active not recruitingPHASE3INTERVENTIONAL

Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

This study is for adults with severe hypertriglyceridemia, a condition where there's too much fat (triglycerides) in the blood. Researchers are testing a new medicine called Plozasiran, given as an injection, to see if it can lower these triglyceride levels safely and effectively. Participants will receive either Plozasiran or a placebo (a dummy injection) over a year, with injections every three months. The study will monitor their health and triglyceride levels. After the initial year, there's an opportunity for eligible participants to continue receiving the treatment in an extended study phase. This is a Phase 3 study, meaning the treatment has already undergone earlier testing.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Arrowhead Pharmaceuticals

Enrolment target

446

Start

22 Jul 2024

Estimated completion

01 Sep 2026

Severe Hypertriglyceridemia

What is this study about?

This research study is looking at a new treatment called Plozasiran for a condition called severe hypertriglyceridemia. This means you have very high levels of triglycerides, which are a type of fat in your blood. High triglyceride levels can be a concern for your health. The aim of this study is to find out if Plozasiran injections can safely and effectively lower these high triglyceride levels in adults.

Participants in the study will be randomly assigned to receive either Plozasiran or a placebo. A placebo is a dummy injection that looks exactly like the real medicine but contains no active drug. This is done so researchers can accurately compare the effects of the new medicine against no treatment. Neither you nor your study doctor will know which you are receiving, which helps ensure the results are unbiased. The injections will be given once every three months over a period of 12 months.

This is a Phase 3 clinical trial, which means the treatment has already been tested in smaller groups of people and shown some promising results. This larger study aims to confirm its safety and effectiveness before it can be considered for wider use. After the initial 12 months, if you meet certain criteria, you might be offered the chance to continue taking Plozasiran in an optional, extended part of the study.

Key takeaways

This study evaluates a new injection, Plozasiran, for severe high triglycerides.
Participants will receive either Plozasiran or a placebo for 12 months.
Injections are given every three months.
The study aims to check the safety and effectiveness of the new treatment.
Potential for an optional extension phase after the first year.
Participation involves regular clinic visits and health assessments.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older. If you are a woman, you must not be pregnant, planning to become pregnant, or breastfeeding. All participants must have a confirmed diagnosis of severe hypertriglyceridemia, meaning your triglyceride levels have been consistently very high in the past and at the start of the study.

There are also some other important health checks. Your 'bad' cholesterol (LDL-C) and a blood sugar marker (HbA1C) need to be within certain limits. You should be willing to follow dietary advice and maintain a stable low-fat diet. You should also be currently taking standard medications for your cholesterol and triglycerides, unless your doctor has said you can't tolerate them.

There are some reasons why you might not be able to join. For instance, if you have a specific genetic type of very high cholesterol called familial chylomicronemia syndrome, or if you've had inflammation of the pancreas (pancreatitis) recently. If you've recently used certain other types of similar investigational drugs, you might also be excluded. The study also has a limit on body weight, so your BMI (Body Mass Index) must be 45 or less.

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?
Do you have a diagnosis of very high triglycerides (SHTG)?
Are you able to maintain a stable low-fat diet and follow dietary advice?
Are you currently on standard cholesterol/triglyceride lowering medications (unless intolerant)?
Are you not currently pregnant, planning to become pregnant, or breastfeeding (if a woman)?
Do you not have a known diagnosis of familial chylomicronemia syndrome (FCS)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to check if you meet all the requirements. If eligible, you will be randomly assigned to receive either the Plozasiran injection or a placebo injection. You will receive an injection once every three months for a total of four doses over 12 months. During this time, you'll have regular visits to the clinic for health checks, blood tests, and to monitor your triglyceride levels and general well-being. The study team will explain all procedures in detail. After the initial 12 months, if you qualify and choose to, you may be able to continue receiving Plozasiran in an optional extension part of the study under a separate agreement.

Potential risks and benefits

Taking part in a clinical study may offer potential benefits, such as access to a new treatment before it's widely available and contributing to medical knowledge that could help others. However, there are also potential risks involved, including possible side effects from the Plozasiran injection or the placebo, or discomfort from study procedures like blood tests. The research team will carefully monitor your health throughout the study and provide you with detailed information about all known or potential risks. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (196)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Center 1
Verified postcode
Garden Grove, United States
Research Center 2
Verified postcode
Lake Forest, United States
Research Center 3
Verified postcode
Montclair, United States
Research Center 4
Verified postcode
Panorama City, United States
Research Center 5
Verified postcode
Redding, United States
Research Center 6
Verified postcode
Colorado Springs, United States
Research Center 7
Verified postcode
Hialeah, United States
Research Center 8
Verified postcode
Lake City, United States
Research Center 9
Verified postcode
Miami Lakes, United States
Research Center 10
Verified postcode
Mt. Dora, United States
Research Center 11
Verified postcode
Orlando, United States
Research Center 12
Verified postcode
Pensacola, United States

Common questions

What are triglycerides?

Triglycerides are a type of fat found in your blood. High levels can be a sign of health issues.

What is a placebo?

A placebo is a 'dummy' injection that looks like the real medicine but contains no active drug, used for comparison.

How often will I receive injections?

You will receive an injection once every three months for a total of four doses over one year.

Can I stop participating in the study at any time?

Yes, you have the right to withdraw from the study at any point, for any reason, without consequences for your care.

What happens after the first year?

After 12 months, eligible participants may be offered the chance to continue with the treatment in an optional extension phase of the study.