RecruitingPhase 2NCT07269210
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 (Solbinsiran) in Adults With Severe Hypertriglyceridemia
Sponsor
Eli Lilly and Company
Enrollment
60 participants
Start Date
Dec 8, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria4
- 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
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Interventions
DRUGSolbinsiran
Administered SC
DRUGPlacebo
Administered SC
Locations(40)
View Full Details on ClinicalTrials.gov
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NCT07269210