Active not recruitingPHASE3INTERVENTIONAL

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

This research study is testing a new injectable medication called plozasiran in adults who have high levels of fats called triglycerides in their blood. High triglycerides can increase the risk of heart problems and other health issues. The study aims to find out if plozasiran is safe and effective at lowering these levels. Participants will receive either the plozasiran injection or a placebo (a dummy injection with no active medicine) every three months for a year. Researchers will then check their triglyceride levels and monitor for any side effects to understand how well the new medicine works.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Arrowhead Pharmaceuticals

Enrolment target

1,456

Start

21 May 2024

Estimated completion

01 Sep 2026

Hypertriglyceridemia

What is this study about?

This study is about a new medicine, an injection called plozasiran, for people who have higher than normal levels of a type of fat in their blood called triglycerides. Having too many triglycerides can be a problem because it's linked to health issues like heart disease.

Doctors are regularly looking for new and better ways to help people manage their triglyceride levels. This particular study is in its 'Phase 3' stage, which means the medicine has already been tested in earlier studies and shown some promise. Now, it's being tested on a larger group of people to confirm its safety and how well it works before it can potentially become available for wider use.

The main goal is to compare plozasiran with a 'placebo', which looks exactly like the real medicine but contains no active drug. This helps researchers understand whether any changes they see are truly due to the new medicine or if they might have happened anyway. By joining, you could help doctors learn more about managing high triglycerides.

Key takeaways

Tests a new injection (plozasiran) for high blood triglycerides.
Aims to see if the drug is safe and helps lower triglyceride levels.
Participants will receive either plozasiran or a dummy injection every 3 months.
The study includes regular check-ups and monitoring over about a year.
Could help improve future treatments for high triglycerides.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or over. If you have been diagnosed with high triglycerides and your levels are between certain amounts, you might be able to take part. Women can join if they are not pregnant, do not plan to become pregnant during the study, and are not breastfeeding.

To be eligible, your triglyceride levels will be checked twice during the screening period to make sure they are consistently within the study's required range. Your 'bad' cholesterol (LDL-C) and a blood sugar measure (HbA1c) will also need to be within specific limits.

There are also reasons why you might not be able to join. For example, if you've recently had pancreatitis or if you have a very high Body Mass Index (BMI). Also, if you’ve used certain other similar types of medication in the past year, you might not be eligible. The study team will review all your medical information carefully to see if you can 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 high triglycerides?
Are you able to follow a low-fat diet and take your usual medications?
Are you a woman who is not pregnant, not planning pregnancy, and not breastfeeding?
Have you had pancreatitis in the last month?
Have you used similar study medicines within the last year?

Answer every question to see your result.

What does participation involve?

If you decide to take part and are found eligible, you'll be assigned by chance to receive either the plozasiran injection or a placebo (a dummy injection). You won't know which one you're getting, nor will the study team.

You will receive a total of four injections, one every three months, over a year. Throughout the study, you'll have regular visits to the clinic so the medical team can monitor your health, check your triglyceride levels, and make sure you're not experiencing any unexpected side effects. You'll also be expected to follow advice on a low-fat diet and continue any other triglyceride-lowering medicines your doctor has prescribed, unless your doctor says you can't tolerate them.

Each visit will involve various assessments, which could include blood tests, physical examinations, and questions about how you're feeling. The study will last for a specific period, around one year for the treatment phase, plus some follow-up appointments, to assess the long-term effects of the treatment.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. A possible benefit of this study is that the new medicine might help lower your triglyceride levels more effectively than your current treatment, which could improve your health. However, because you might receive a placebo, there’s a chance you won't get the active drug, and your condition might not improve. There's also a risk of side effects from the study medication, though these will be closely monitored. The study team will explain all known potential side effects to you. It's important to remember that participating is entirely 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 (235)

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

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
Garden Grove, United States
Research Site 6
Verified postcode
Huntington Beach, United States
Research Site 7
Verified postcode
Lake Forest, United States
Research Site 8
Verified postcode
Lincoln, United States
Research Site 9
Verified postcode
Long Beach, United States
Research Site 10
Verified postcode
Montclair, United States
Research Site 11
Verified postcode
Oxnard, United States
Research Site 12
Verified postcode
Redding, United States

Common questions

What are triglycerides and why are they important?

Triglycerides are a type of fat in your blood. High levels can increase your risk of heart disease and other health problems, so it's important to keep them in check.

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 understand if the real medicine is truly causing any effects.

How often will I need to get injections?

If you take part, you'll receive an injection once every three months, making a total of four injections over the course of about a year.

Will I have to pay to join the study?

No, you will not have to pay for the study medication or any study-related tests or appointments.

Can I continue my usual medications while in the study?

Yes, you should continue your regular medications for high triglycerides and cholesterol, unless the study doctor advises otherwise. You'll also get diet advice.