Solbinsiran for Hypertriglyceridemia

(SOLARIS-1 Trial)

Not yet recruiting at 38 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Cardiovascular event, Pancreatitis, Chylomicronemia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called solbinsiran, an experimental drug, to determine if it can safely and effectively lower triglyceride levels in people with severe hypertriglyceridemia (very high levels of fat in the blood). Participants will receive two injections, and their results will be compared to those receiving a placebo. It suits individuals with triglyceride levels of 500 mg/dL or higher who haven't experienced recent major heart issues. The trial aims to find better options for managing high triglycerides, a risk factor for heart disease. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in managing high triglycerides.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that solbinsiran is likely to be safe for humans?

Research has shown that solbinsiran was well-tolerated in earlier studies. For example, one study found no safety issues even at the highest dose of 960 mg. Most side effects were mild or moderate, and no serious problems were reported. These findings suggest that solbinsiran is likely safe, which is encouraging for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Solbinsiran is unique because it targets hypertriglyceridemia through a novel mechanism. Unlike traditional treatments, which commonly include fibrates, niacin, or omega-3 fatty acids that work by reducing triglyceride production or increasing its breakdown, Solbinsiran is designed to interfere with RNA processes, specifically targeting the production of proteins involved in triglyceride metabolism. This RNA interference approach could lead to more precise control of triglyceride levels with potentially fewer side effects. Researchers are excited about Solbinsiran because it represents a cutting-edge approach that might offer more effective and safer management of high triglyceride levels compared to current options.

What evidence suggests that solbinsiran might be an effective treatment for hypertriglyceridemia?

Research has shown that solbinsiran, which participants in this trial may receive, may help lower triglycerides and other fats in the blood. One study found that solbinsiran reduced triglycerides and a type of cholesterol called VLDL-C by about 50%. It also lowered a protein linked to cholesterol, called apoB, by 14.3% compared to a placebo. Another study found it could reduce triglycerides by up to 70% and LDL cholesterol by up to 42%. These findings suggest solbinsiran could be helpful for people with very high triglyceride levels. ^{1 2 3 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for individuals with severe hypertriglyceridemia, a condition where there's an excess of triglycerides (a type of fat) in the blood. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have specific levels of triglycerides.

Inclusion Criteria

History of fasting triglyceride levels of ≥500 milligrams per deciliter (mg/dL), based on medical history

Fasting triglyceride level ≥500 mg/dL at two separate visits during screening (at least 7 days apart)

Body mass index (BMI) within the range of 18.5 to 45.0 kilograms per square meter (kg/m2) (inclusive)

Exclusion Criteria

I have had acute pancreatitis in the last year.

I have a genetic diagnosis of Familial Chylomicronemia Syndrome.

I have not undergone or plan to undergo any gene editing treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two subcutaneous injections of solbinsiran or placebo

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Solbinsiran

Trial Overview The study tests Solbinsiran against a placebo to see if it can lower triglyceride levels effectively. Participants will receive two subcutaneous injections, which means they'll get shots under their skin.

How Is the Trial Designed?

Group I: Solbinsiran Experimental Treatment 1 Intervention

Participants will receive solbinsiran subcutaneously (SC)

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07269210

A Study of Solbinsiran (LY3561774) in Participants With ... The purpose of this study is to evaluate the safety and efficacy of solbinsiran in lowering triglycerides and other lipid measures compared to placebo in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40179932/

a double-blind, randomised, placebo-controlled, phase 2 trial This study aimed to assess the durability and efficacy of solbinsiran in reducing concentrations of atherogenic lipoproteins in adults with mixed dyslipidaemia.

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00507-0/fulltext

a double-blind, randomised, placebo-controlled, phase 2 trial By contrast, solbinsiran reduced triglycerides and VLDL-C by approximately 50%, and reduced apoB and LDL-C. As triglyceride-rich ...

4. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2025/03/28/03/10/prolong-ang3

A Study of Solbinsiran in Participants With Mixed ... In the PROLONG-ANG3 phase 2 trial, solbinsiran 400 mg significantly reduced apoB by 14.3% at day 180 compared with placebo, meeting the primary ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.005

Effect of ANGPTL3 Inhibition With Solbinsiran in Preclinical ... The repeat-dose study demonstrated reductions in ANGPTL3 of 89% ± 6%, triglycerides up to 70% ± 13%, LDL cholesterol up to 42% ± 14%, non–high- ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-solbinsiran-ly3561774-in-participants-with-severe-hypertriglyceridemia?comeFrom=%7B%22type%22%3A%22site%22%2C%22slug%22%3A%22catalina-research-institute-llc-montclair-ca%22%7D

A Study of Solbinsiran (LY3561774) in Participants With ... The purpose of this study is to evaluate the safety and efficacy of solbinsiran in lowering triglycerides and other lipid measures compared ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40158211

Effect of ANGPTL3 Inhibition With Solbinsiran in Preclinical ... The repeat-dose study demonstrated reductions in ANGPTL3 of 89% ± 6%, triglycerides up to 70% ± 13%, LDL cholesterol up to 42% ± 14%, non-high- ...