What is solbinsiran studying for severe hypertriglyceridemia?

Solbinsiran is being studied to see if it can safely reduce very high triglyceride levels and other related blood fats in adults with severe hypertriglyceridemia. This trial compares solbinsiran to a placebo to understand its effects better. The study is sponsored by Eli Lilly and Company and focuses on adults with fasting triglycerides of 500 mg/dL or more.

Who may be eligible for this severe hypertriglyceridemia clinical trial?

Adults aged 18 years or older with a history of fasting triglyceride levels of 500 mg/dL or higher may be eligible. Participants should have a body mass index between 18.5 and 45.0 kg/m2 and cannot have had a major cardiovascular event in the past 3 months. People with Familial Chylomicronemia Syndrome are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this severe hypertriglyceridemia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07269210

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 Solbinsiran in Adults With Severe Hypertriglyceridemia

Led by Eli Lilly and Company · Updated on 2026-04-22

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of solbinsiran in lowering triglyceride levels and other lipid measures in adults with severe hypertriglyceridemia. This phase 2 study compares solbinsiran to a placebo and aims to better understand how this treatment might help people with this condition. The trial is sponsored by Eli Lilly and Company and focuses on participants with very high fasting triglyceride levels. Participants will be randomly assigned to receive either solbinsiran or a placebo through two subcutaneous injections. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. The main treatment period includes monitoring changes in triglycerides and other lipid markers over 16 to 24 weeks. During the study, participants will have fasting triglyceride levels measured at baseline and during follow-up visits. Researchers will also assess changes in other blood lipids such as ANGPTL3, VLDL cholesterol, and non-HDL cholesterol at 24 weeks. Pharmacokinetic testing will measure how the body processes solbinsiran after dosing. The study runs from December 2025 to August 2027, with safety and efficacy monitored throughout.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

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

You will not qualify if you...

Have had a major atherosclerotic cardiovascular event within the past 3 months prior to screening
Have a known genetically confirmed diagnosis of Familial Chylomicronemia Syndrome
Have a history of or planned treatment involving any gene editing or gene therapy modalities, including but not limited to CRISPR-based, viral vector-mediated, or other genetic modification techniques
Have a history of chronic alcohol abuse within 3 years prior to screening

Research Team

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

Physicians interested in becoming principal investigators please contact

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