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RecruitingPhase 2NCT07269210

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

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Trial Parameters

ConditionSevere Hypertriglyceridemia
SponsorEli Lilly and Company
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment60
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-12-08
Completion2027-03
Interventions
SolbinsiranPlacebo

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Brief 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 Criteria

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

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