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Recruiting Phase 2 NCT07269210

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

Phase 2 – studying effectiveness and dosage
Conditions: Severe Hypertriglyceridemia

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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
Solbinsiran
DRUG
Placebo
DRUG
Locations 40
Canada (3)
Ecogene-21
Chicoutimi
C.I.C. Mauricie inc.
Trois-Rivières
ARC Biosystems
Vancouver
China (6)
Peking University Third Hospital
Beijing
Sichuan Provincial People's Hospital
Chengdu
Guangdong Provincial People's Hospital
Guangzhou
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi
Zhongshan Hospital,Fudan University
Shanghai
The Affiliated Hospital of Xuzhou Medical College
Xuzhou
Japan (2)
The Institute of Medical Science, Asahi Life Foundation
Chūōku
Takai Internal Medicine Clinic
Kamakura-shi
United States (29)
National Heart Institute
Beverly Hills , California
Flourish Research - Bowie
Bowie , Maryland
Investigators Research Group
Brownsburg , Indiana
Great Lakes Clinical Trials - Ravenswood
Chicago , Illinois
Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
Covington , Kentucky
CMR of Greater New Haven, LLC
Hamden , Connecticut
Cardiovascular Specialists of Willowbrook
Houston , Texas
Northeast Research Institute - Downtown Office
Jacksonville , Florida
AB Clinical Trials
Las Vegas , Nevada
Ark Clinical Research
Long Beach , California
Stroobants Cardiovascular Center
Lynchburg , Virginia
Southern Endocrinology Associates
Mesquite , Texas
Novera Clinical Research
Miami , Florida
Inpatient Research Clinic
Miami Lakes , Florida
Catalina Research Institute, LLC
Montclair , California
Weill Cornell Medical College
New York , New York
Icahn School of Medicine at Mount Sinai
New York , New York
TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
Newport News , Virginia
Valley Clinical Trials, Inc.
Northridge , California
Clinical Research of Philadelphia
Pennington , New Jersey
Axsendo Clinical Research - Peak Heart & Vascular - Phoenix
Phoenix , Arizona
Eastside Research Associates
Redmond , Washington
Carilion Clinic
Roanoke , Virginia
American Research Corporation at Texas Liver Institute
San Antonio , Texas
Endeavor Clinical Trials
San Antonio , Texas
UW Medicine Diabetes Institute
Seattle , Washington
NOT_YET_RECRUITING
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson , Arizona
Clinical Site Partners, LLC dba Flourish Research
Winter Park , Florida
University of Massachusetts Chan Medical School
Worcester , Massachusetts
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
08.12.2025
Completion date
01.08.2027
Registry ID
NCT07269210
Source
clinicaltrials.gov
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