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

ID#: NCT07269210

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: December 08, 2025

End Date: August 01, 2027

Contact Information:
Trial questions or participation questions
317-615-4559
Physicians interested in becoming principal investigators please contact
Summary:

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 participants with severe hypertriglyceridemia. Participants will receive two subcutaneous injections.

Eligibility:



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)

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

Exclusion Criteria:

- Have had a major atherosclerotic cardiovascular event within the past 3 months prior to screening

- Have a history of acute pancreatitis within 12 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