A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 (Solbinsiran) in Adults With Severe Hypertriglyceridemia
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Arizona
Axsendo Clinical Research - Peak Heart & Vascular - Phoenix
RECRUITING
Phoenix
Synexus Clinical Research US, Inc./Orange Grove Family Practice
RECRUITING
Tucson
California
National Heart Institute
RECRUITING
Beverly Hills
Ark Clinical Research
RECRUITING
Long Beach
Catalina Research Institute, LLC
RECRUITING
Montclair
Valley Clinical Trials, Inc.
RECRUITING
Northridge
Connecticut
CMR of Greater New Haven, LLC
RECRUITING
Hamden
Florida
Northeast Research Institute - Downtown Office
RECRUITING
Jacksonville
Novera Clinical Research
RECRUITING
Miami
Inpatient Research Clinic
NOT_YET_RECRUITING
Miami Lakes
Clinical Site Partners, LLC dba Flourish Research
RECRUITING
Winter Park
Illinois
Great Lakes Clinical Trials - Ravenswood
RECRUITING
Chicago
Indiana
Investigators Research Group
RECRUITING
Brownsburg
Kentucky
Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
RECRUITING
Covington
Massachusetts
University of Massachusetts Chan Medical School
NOT_YET_RECRUITING
Worcester
Maryland
Flourish Research - Bowie
RECRUITING
Bowie
New Jersey
Clinical Research of Philadelphia
RECRUITING
Pennington
Nevada
AB Clinical Trials
RECRUITING
Las Vegas
New York
Icahn School of Medicine at Mount Sinai
NOT_YET_RECRUITING
New York
Weill Cornell Medical College
RECRUITING
New York
Texas
Cardiovascular Specialists of Willowbrook
RECRUITING
Houston
Southern Endocrinology Associates
RECRUITING
Mesquite
American Research Corporation at Texas Liver Institute
RECRUITING
San Antonio
Endeavor Clinical Trials
RECRUITING
San Antonio
Virginia
Stroobants Cardiovascular Center
RECRUITING
Lynchburg
TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
RECRUITING
Newport News
Carilion Clinic
RECRUITING
Roanoke
Washington
Eastside Research Associates
RECRUITING
Redmond
UW Medicine Diabetes Institute
NOT_YET_RECRUITING
Seattle
Other Locations
Canada
Ecogene-21
RECRUITING
Chicoutimi
C.I.C. Mauricie inc.
RECRUITING
Trois-rivières
ARC Biosystems
RECRUITING
Vancouver
China
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Henan University of Science &Technology
NOT_YET_RECRUITING
Luoyang Shi
Zhongshan Hospital,Fudan University
NOT_YET_RECRUITING
Shanghai
The Affiliated Hospital of Xuzhou Medical College
NOT_YET_RECRUITING
Xuzhou
Japan
The Institute of Medical Science, Asahi Life Foundation
RECRUITING
Chūōku
Takai Internal Medicine Clinic
RECRUITING
Kamakura-shi
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-12-08
Estimated Completion Date: 2027-08
Participants
Target number of participants: 60
Treatments
Experimental: Solbinsiran
Participants will receive solbinsiran subcutaneously (SC)
Placebo_comparator: Placebo
Participants will receive placebo SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company