Active not recruitingPHASE3INTERVENTIONAL

Study of Plozasiran in Adults With Severe Hypertriglyceridemia

This study is for adults who have very high levels of a type of fat in their blood called triglycerides. These high levels are known as severe hypertriglyceridemia (SHTG). Researchers want to find out if a new treatment, an injection called plozasiran, is safe and effective in lowering these triglyceride levels. Half of the participants will receive the plozasiran injection, and the other half will receive a dummy injection (placebo). Neither the participants nor the doctors will know who is getting which. The treatment is given four times over a year. After this, eligible participants might be able to continue receiving the treatment in an ongoing study.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Arrowhead Pharmaceuticals

Enrolment target

311

Start

23 Jul 2024

Estimated completion

01 Sep 2026

Severe Hypertriglyceridemia

What is this study about?

This study is looking at a new medicine called plozasiran, which is given as an injection. It's designed for adults who have a condition called severe hypertriglyceridemia, which simply means they have very high levels of unhealthy fats called triglycerides in their blood. Having consistently high triglycerides can be a concern for your health, and this study aims to see if plozasiran can help bring these levels down safely.

The study is in 'Phase 3,' which means it's one of the final stages of testing before a new medicine might be considered for wider use. During this phase, a larger group of people receive the new treatment. This helps researchers get a better understanding of how well it works and if there are any side effects compared to a placebo – which is a dummy treatment that looks just like the real thing but contains no medicine.

Taking part would mean you would receive either the plozasiran injection or the placebo. Neither you nor your study doctor will know which one you are getting. This helps make sure the results are fair and accurate. The main goal is to find out if plozasiran can effectively lower very high triglyceride levels and if it is safe for people to use.

Key takeaways

This study is testing a new injection (plozasiran) for very high blood fats (triglycerides).
It's a 'Phase 3' study, which means it's a key stage of testing for a new medicine.
Participants will receive either the new drug or a dummy injection (placebo).
The treatment involves four injections over one year, with regular health checks.
The main goals are to check if plozasiran is safe and effectively lowers triglyceride levels.
You can discuss with your doctor if this study might be suitable for you.

Who may be eligible?

This study is looking for adults who have severe hypertriglyceridemia, meaning they have consistently very high levels of triglycerides in their blood. Your doctor would need to confirm this with blood tests, showing levels above a certain point. Your 'bad' cholesterol (LDL-C) should not be too high, and your blood sugar control, measured by HbA1C, should be at or below 9%. You should also be taking your usual medications for cholesterol, unless your doctor has advised against them.

There are some reasons why you might not be able to join. For example, if you've recently used certain types of similar medications or other experimental drugs for cholesterol within a specific timeframe, you likely wouldn't be eligible. Also, if you have a specific genetic condition called familial chylomicronemia syndrome (FCS) or a very high body mass index (BMI) over 45, you generally wouldn't be able to participate.

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 an adult aged 18 or over?
Have you been diagnosed with very high triglyceride levels (severe hypertriglyceridemia) by your doctor?
Are your current 'bad' cholesterol (LDL-C) levels not too high?
Is your blood sugar control (HbA1C) at or below 9%?
Are you currently taking your usual cholesterol medications, or did your doctor say you can't take them?
Have you not used certain other experimental cholesterol medications in the last year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'd first have a screening period to check if you meet all the requirements. This would involve a couple of blood tests for your triglyceride levels about a week apart. If you're eligible, you would then be 'randomised.' This means you'd be randomly assigned to either receive the plozasiran injection or a placebo (a dummy injection). You would receive a total of four injections, given once every three months over a year. Throughout this time, you would have regular visits to the clinic so the study team can check your health, conduct blood tests, and monitor how you're responding to the treatment. After the first year, if you wish and still meet certain criteria, you might have the opportunity to continue receiving the plozasiran treatment in a follow-up study, which would be explained in more detail at that time.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit could be that if you receive the active treatment, plozasiran, it might help lower your severely high triglyceride levels, which could be good for your health. However, as with all new medicines, there could be unknown side effects, or you might experience discomfort from injections or clinic visits. You might also receive the placebo, which means you wouldn't get the active medicine. The study team will explain all known potential risks in detail, and it's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (149)

Research Site 1
Verified postcode
Birmingham, United States
Research Site 2
Verified postcode
Mobile, United States
Research Site 3
Verified postcode
Beverly Hills, United States
Research Site 4
Verified postcode
Canoga Park, United States
Research Site 5
Verified postcode
Huntington Beach, United States
Research Site 6
Verified postcode
Lincoln, United States
Research Site 7
Verified postcode
Long Beach, United States
Research Site 8
Verified postcode
Oxnard, United States
Research Site 9
Verified postcode
Clearwater, United States
Research Site 10
Verified postcode
North Miami, United States
Research Site 11
Verified postcode
Sarasota, United States
Research Site 12
Verified postcode
Lawrenceville, United States

Common questions

What are triglycerides?

Triglycerides are a type of fat found in your blood. Our bodies use them for energy, but very high levels can be unhealthy.

What does 'severe hypertriglyceridemia' mean?

This simply means you have extremely high levels of triglycerides in your blood. It's a condition doctors often want to manage.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active drug. It helps researchers compare the new medicine fairly.

How is the treatment given?

The experimental treatment, plozasiran, is given as an injection, administered four times over one year.

Can I continue my other medications?

Yes, generally you should continue your usual cholesterol-lowering medications as advised by your doctor, unless you can't tolerate them. The study team will review all your medications.