Active not recruitingPHASE3INTERVENTIONAL

CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

This ongoing research, called CORE-OLE, is for people who have very high levels of fats called triglycerides in their blood. These people have already started taking a new medicine called Olezarsen in previous studies. The main goal of this study is to continue watching how safe Olezarsen is over a longer period and whether people can take it without too many problems. Participants will receive Olezarsen injections under the skin for about three years. This study helps doctors understand more about this medicine and how it might help people manage their condition. It's a 'Phase 3' study, meaning it's one of the final steps before a medicine might be considered for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Ionis Pharmaceuticals, Inc.

Enrolment target

885

Start

13 Dec 2022

Estimated completion

01 Mar 2027

Severe Hypertriglyceridemia

What is this study about?

This study is focusing on a condition called Severe Hypertriglyceridemia (SHTG). This simply means you have very high levels of something called triglycerides in your blood. Triglycerides are a type of fat, and having too much can increase your risk of certain health problems.

The study involves a medicine named Olezarsen. If you're taking part, you'll be giving yourself injections of this medicine under your skin. The main aim is to see if Olezarsen is safe for people to use over a long time and if it causes any side effects. This study is an extension, which means it’s designed for people who have already been taking Olezarsen in earlier trials.

By continuing to observe how Olezarsen works in people who have been taking it for a while, researchers can gather more important information. This helps them understand its long-term effects and how useful it could be in managing very high triglyceride levels. It's a crucial step in understanding if this medicine could become a treatment option in the future.

Key takeaways

This study is for people with very high blood fats (triglycerides) who have previously taken Olezarsen.
It aims to check the long-term safety and how well Olezarsen is tolerated.
Participation involves self-administered injections of Olezarsen for about three years.
You must be on a stable blood-fat-lowering medication plan.
This is a 'Phase 3' study, an important step in medicine development.
Your general health will be monitored regularly throughout the study.

Who may be eligible?

To join this study, you must have already completed one of the previous Olezarsen studies (ISIS 678354-CS5 or ISIS 678354-CS6) safely and without dropping out early. Your study doctor would need to agree that you are suitable to continue.

You also need to be on a steady and stable treatment plan for lowering your blood fats, following the usual guidelines your doctors recommend. If your plan has changed recently, it needs to have been stable for at least 4 weeks before you can join this study during its initial check period.

In some cases, if you finished an earlier Olezarsen study that only lasted 53 weeks and your doctor says it's safe, you might be able to rejoin this new, longer study. The study is open to both men and women, aged 18 years and older.

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.

Have I already completed an Olezarsen study (ISIS 678354-CS5 or CS6) safely?
Am I currently on a stable treatment plan for lowering my blood fats?
Is my current blood fat medication plan based on standard medical advice?
Am I at least 18 years old?

Answer every question to see your result.

What does participation involve?

If you join this study, you would continue to take Olezarsen, which is given by an injection under your skin. This treatment period will last for about three years (157 weeks). Before starting the main treatment, there's a short 31-day check period to make sure you're still eligible.

After the treatment period, there will be a follow-up period of about 13 weeks where the study team will continue to monitor your health. You will have regular visits to the clinic for checks and assessments, though the exact schedule would be shared with you by the study team. These visits help the researchers understand how you're responding to the treatment and your general health, including any changes in your medication for lowering blood fats.

Potential risks and benefits

Participating in this study might mean you continue to benefit from Olezarsen, potentially helping to manage your very high triglyceride levels. You would also be playing an important role in helping doctors and researchers learn more about this medicine, which could help future patients. However, like all medicines, Olezarsen may have side effects, and your doctor will discuss these with you. You will be closely monitored for any issues. Please remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (262)

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

LA Universal Research Center, Inc.
Verified postcode
Los Angeles, United States
University of California, San Diego (UCSD)
Verified postcode
San Diego, United States
Metabolic Institute of America
Verified postcode
Tarzana, United States
Excel Medical Clinical Trials
Verified postcode
Boca Raton, United States
Finlay Medical Research
Verified postcode
Greenacres City, United States
Columbus Clinical Services, LLC
Verified postcode
Miami, United States
Finlay Medical Research
Verified postcode
Miami, United States
Innovia Research Center, Inc.
Verified postcode
Miramar, United States
Harmony Clinical Research, Inc.
Verified postcode
North Miami Beach, United States
R & B Medical Center LLC
Verified postcode
Tampa, United States
VICIS Clinical Research
Verified postcode
Tampa, United States
JSV Clinical Research Study, Inc.
Verified postcode
Tampa, United States

Common questions

What is Severe Hypertriglyceridemia (SHTG)?

It's a medical condition where you have extremely high levels of a type of fat called triglycerides in your blood.

What is Olezarsen?

Olezarsen is the name of the new medicine being studied in this trial to help manage SHTG.

How is Olezarsen given?

It's given as an injection under the skin, similar to how some people give themselves insulin.

How long will I be in this study?

The treatment part of the study lasts about three years (157 weeks), with an initial check period and then a follow-up period after the treatment ends.

Why is this study important?

It helps researchers understand the long-term safety and effects of Olezarsen, which could potentially become a new treatment for very high triglycerides.