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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Severe Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT07269210

Run by

Eli Lilly and Company

People needed

60

Starts

2025-12-08

Expected to finish

2027-08-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Axsendo Clinical Research - Peak Heart & Vascular - Phoenix — Phoenix, Arizona, United States (enrolling)
• Synexus Clinical Research US, Inc./Orange Grove Family Practice — Tucson, Arizona, United States (enrolling)
• National Heart Institute — Beverly Hills, California, United States (enrolling)
• Ark Clinical Research — Long Beach, California, United States (enrolling)
• Catalina Research Institute, LLC — Montclair, California, United States (enrolling)
• Valley Clinical Trials, LLC dba Flourish Research — Northridge, California, United States (enrolling)
• CMR of Greater New Haven, LLC — Hamden, Connecticut, United States (enrolling)
• Northeast Research Institute - Downtown Office — Jacksonville, Florida, United States (enrolling)
• Novera Clinical Research — Miami, Florida, United States (enrolling)
• Inpatient Research Clinic — Miami Lakes, Florida, United States (enrolling)
• Clinical Site Partners, LLC dba Flourish Research — Winter Park, Florida, United States (enrolling)
• Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States (enrolling)
• Investigators Research Group — Brownsburg, Indiana, United States (enrolling)
• Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital — Covington, Kentucky, United States (enrolling)
• Flourish Research - Bowie — Bowie, Maryland, United States (enrolling)
• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (enrolling)
• AB Clinical Trials — Las Vegas, Nevada, United States (enrolling)
• Clinical Research of Philadelphia — Pennington, New Jersey, United States (enrolling)
• Weill Cornell Medical College — New York, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Cardiovascular Specialists of Willowbrook — Houston, Texas, United States (enrolling)
• Southern Endocrinology Associates — Mesquite, Texas, United States (enrolling)
• American Research Corporation at Texas Liver Institute — San Antonio, Texas, United States (enrolling)
• Endeavor Clinical Trials — San Antonio, Texas, United States (enrolling)
• Stroobants Cardiovascular Center — Lynchburg, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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