RecruitingPHASE2INTERVENTIONAL

A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia

This research is looking into a new medicine called Solbinsiran for individuals who have severely high levels of triglycerides in their blood. Triglycerides are a type of fat, and very high levels can be a health concern. The main goal of the study is to find out if Solbinsiran is safe and effective at reducing these high triglyceride levels, as well as other related fats, when compared to a placebo (an inactive treatment). Participants in the study will receive two injections under the skin. This is a Phase 2 study, meaning it's still in the earlier stages of testing to gather more information on the medicine's safety and how well it works.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Eli Lilly and Company

Enrolment target

Start

08 Dec 2025

Estimated completion

01 Aug 2027

Severe Hypertriglyceridemia

What is this study about?

This study is called "A Study of Solbinsiran in Participants With Severe Hypertriglyceridemia." In simpler terms, it's a study looking at a new medicine called Solbinsiran for people who have a condition where they have very high levels of a type of fat in their blood called triglycerides. Think of triglycerides as energy storage in your body; however, too much can sometimes lead to health problems.

The main purpose of this research is to see if Solbinsiran can help bring these high triglyceride levels down. Researchers also want to make sure the medicine is safe to use. To do this, some participants will receive Solbinsiran, while others will receive a placebo, which looks just like the real medicine but contains no active ingredients. This helps researchers fairly compare the effects of the new medicine.

Taking part in a study like this is important because it helps scientists learn more about new ways to treat health conditions. If Solbinsiran proves to be safe and effective, it could become a new option for people managing severe hypertriglyceridemia in the future.

Key takeaways

The study tests a new medicine (Solbinsiran) for very high blood fats (triglycerides).
It aims to check if Solbinsiran is safe and lowers triglyceride levels.
Participants will receive two injections, either the real medicine or a dummy treatment.
The study is for adults over 18 with confirmed severe hypertriglyceridemia.
Participation involves regular check-ups and blood tests.

Who may be eligible?

To join this study, you would need to have a history of very high triglyceride levels in your blood, specifically levels of 500 mg/dL or higher. This would need to be confirmed with two separate blood tests during the screening process, taken at least a week apart. Your body mass index (BMI), which is a measure of your weight in relation to your height, would also need to be within a certain range.

However, there are reasons why you might not be able to join. For example, if you've had a serious heart or blood vessel event (like a heart attack or stroke) in the last three months, or if you have a specific genetic condition called Familial Chylomicronemia Syndrome, you wouldn't be able to participate. Also, if you've had certain types of genetic treatments in the past, or a history of chronic alcohol abuse within the last three years, you would not be eligible. The study is open to both men and women aged 18 and over.

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.

Do you have a history of very high triglyceride levels (500 mg/dL or more)?
Are your triglyceride levels currently 500 mg/dL or more on two recent blood tests?
Are you aged 18 or older?
Have you NOT had a major heart event (like a heart attack) in the last 3 months?
Have you NOT had certain genetic treatments or chronic alcohol abuse in the last 3 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a screening process to check if you meet all the criteria. This typically involves blood tests, health checks, and a review of your medical history. If you are eligible, you would receive the study medicine (either Solbinsiran or a placebo) through injections given under your skin twice during the study period. You would also have regular appointments to monitor your salud, have blood samples taken to check your triglyceride levels, and discuss any side effects you might experience. The total length of your participation would be explained to you in detail.

Potential risks and benefits

Participating in research always carries potential benefits and risks. You might benefit from closer medical monitoring and access to a new medicine that could potentially help lower your triglyceride levels. However, there's also a chance you might receive the placebo and not the active drug. As with any medicine, Solbinsiran could have side effects, which would be explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

Axsendo Clinical Research - Peak Heart & Vascular - Phoenix
Verified postcode
Phoenix, United States· Recruiting
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Verified postcode
Tucson, United States· Recruiting
National Heart Institute
Verified postcode
Beverly Hills, United States· Recruiting
Ark Clinical Research
Verified postcode
Long Beach, United States· Recruiting
Catalina Research Institute, LLC
Verified postcode
Montclair, United States· Recruiting
Valley Clinical Trials, Inc.
Verified postcode
Northridge, United States· Recruiting
CMR of Greater New Haven, LLC
Verified postcode
Hamden, United States· Recruiting
Northeast Research Institute - Downtown Office
Verified postcode
Jacksonville, United States· Recruiting
Novera Clinical Research
Verified postcode
Miami, United States· Recruiting
Inpatient Research Clinic
Verified postcode
Miami Lakes, United States· Recruiting
Clinical Site Partners, LLC dba Flourish Research
Verified postcode
Winter Park, United States· Recruiting
Great Lakes Clinical Trials - Ravenswood
Verified postcode
Chicago, United States· Recruiting

Common questions

What are triglycerides?

Triglycerides are a type of fat found in your blood. Your body uses them for energy, but very high levels can sometimes be a health concern.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study medicine but contains no active ingredients. It helps researchers compare the effects of the real medicine fairly.

Will I know if I'm getting the real medicine or the placebo?

No, this type of study is 'blinded,' meaning neither you nor your study doctor will know whether you are receiving Solbinsiran or the placebo. This ensures the results are unbiased.

How is the study medicine given?

The study medicine, Solbinsiran or the placebo, is given as two injections just under your skin.

Who is sponsoring this study?

This study is being sponsored by Lilly, a pharmaceutical company.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

lillytrials@lilly.com 317-615-4559 Official trial record

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