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NCT07269210PHASE2Recruiting

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

Eli Lilly and Company

Start Date

12/8/2025

Completion Date

8/1/2027

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

Age Range: 18 years to No maximum

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 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

Interventions

DRUG

Solbinsiran

DRUG

Placebo

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Conditions

Severe Hypertriglyceridemia

Locations

Axsendo Clinical Research - Peak Heart & Vascular - Phoenix

Phoenix, Arizona 85014

United States

Synexus Clinical Research US, Inc./Orange Grove Family Practice

Tucson, Arizona 85741

United States

National Heart Institute

Beverly Hills, California 90211

United States

Ark Clinical Research

Long Beach, California 90815

United States

Catalina Research Institute, LLC

Montclair, California 91763

United States

Valley Clinical Trials, LLC dba Flourish Research

Northridge, California 91325

United States

CMR of Greater New Haven, LLC

Hamden, Connecticut 06517

United States

Northeast Research Institute - Downtown Office

Jacksonville, Florida 32204

United States

Novera Clinical Research

Miami, Florida 33135

United States

Inpatient Research Clinic

Miami Lakes, Florida 33014

United States

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida 32789

United States

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois 60640

United States

Investigators Research Group

Brownsburg, Indiana 46112

United States

Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital

Covington, Kentucky 41011

United States

Flourish Research - Bowie

Bowie, Maryland 20715

United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts 01655

United States

AB Clinical Trials

Las Vegas, Nevada 89119

United States

Clinical Research of Philadelphia

Pennington, New Jersey 08534

United States

Weill Cornell Medical College

New York, New York 10021

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Cardiovascular Specialists of Willowbrook

Houston, Texas 77070

United States

Southern Endocrinology Associates

Mesquite, Texas 75149

United States

American Research Corporation at Texas Liver Institute

San Antonio, Texas 78215

United States

Endeavor Clinical Trials

San Antonio, Texas 78240

United States

Stroobants Cardiovascular Center

Lynchburg, Virginia 24501

United States

TPMG (Tidewater Physicians Multispecialty Group) Clinical Research

Newport News, Virginia 23606

United States

Carilion Clinic

Roanoke, Virginia 24014

United States

Eastside Research Associates

Redmond, Washington 98052

United States

UW Medicine Diabetes Institute

Seattle, Washington 98109

United States

Ecogene-21

Chicoutimi, G7H 7K9

Canada

C.I.C. Mauricie inc.

Trois-Rivières, G8T 7A1

Canada

ARC Biosystems

Vancouver, V6Z 2H2

Canada

Peking University Third Hospital

Beijing, 100091

China

Sichuan Provincial People's Hospital

Chengdu, 610072

China

Guangdong Provincial People's Hospital

Guangzhou, 510000

China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, 471003

China

Zhongshan Hospital,Fudan University

Shanghai, 200032

China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, 221006

China

The Institute of Medical Science, Asahi Life Foundation

Chūōku, 103-0002

Japan

Takai Internal Medicine Clinic

Kamakura-shi, 247-0056

Japan

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, 565-0853

Japan