Actively Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 (Solbinsiran) in Adults With Severe Hypertriglyceridemia
Led by Eli Lilly and Company · Updated on 2026-04-22
60
Participants Needed
40
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of solbinsiran in lowering triglyceride levels and other lipid measures in adults with severe hypertriglyceridemia. This phase 2 study compares solbinsiran to a placebo and aims to better understand how this treatment might help people with this condition. The trial is sponsored by Eli Lilly and Company and focuses on participants with very high fasting triglyceride levels. Participants will be randomly assigned to receive either solbinsiran or a placebo through two subcutaneous injections. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. The main treatment period includes monitoring changes in triglycerides and other lipid markers over 16 to 24 weeks. During the study, participants will have fasting triglyceride levels measured at baseline and during follow-up visits. Researchers will also assess changes in other blood lipids such as ANGPTL3, VLDL cholesterol, and non-HDL cholesterol at 24 weeks. Pharmacokinetic testing will measure how the body processes solbinsiran after dosing. The study runs from December 2025 to August 2027, with safety and efficacy monitored throughout.
CONDITIONS
Brief Title
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 16 to 24 weeks
Participants receive solbinsiran or placebo administered subcutaneously to study the effects on severe hypertriglyceridemia.
Trial Site Locations
Total: 40 locations
1
Axsendo Clinical Research - Peak Heart & Vascular - Phoenix
Phoenix, Arizona, United States, 85014
Actively Recruiting
2
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, United States, 85741
Actively Recruiting
3
National Heart Institute
Beverly Hills, California, United States, 90211
Actively Recruiting
4
Ark Clinical Research
Long Beach, California, United States, 90815
Actively Recruiting
5
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Actively Recruiting
6
Valley Clinical Trials, Inc.
Northridge, California, United States, 91325
Actively Recruiting
7
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States, 06517
Actively Recruiting
8
Northeast Research Institute - Downtown Office
Jacksonville, Florida, United States, 32204
Actively Recruiting
9
Novera Clinical Research
Miami, Florida, United States, 33135
Actively Recruiting
10
Inpatient Research Clinic
Miami Lakes, Florida, United States, 33014
Actively Recruiting
11
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States, 32789
Actively Recruiting
12
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States, 60640
Actively Recruiting
13
Investigators Research Group
Brownsburg, Indiana, United States, 46112
Actively Recruiting
14
Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
Covington, Kentucky, United States, 41011
Actively Recruiting
15
Flourish Research - Bowie
Bowie, Maryland, United States, 20715
Actively Recruiting
16
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
17
AB Clinical Trials
Las Vegas, Nevada, United States, 89119
Actively Recruiting
18
Clinical Research of Philadelphia
Pennington, New Jersey, United States, 08534
Actively Recruiting
19
Weill Cornell Medical College
New York, New York, United States, 10021
Actively Recruiting
20
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
21
Cardiovascular Specialists of Willowbrook
Houston, Texas, United States, 77070
Actively Recruiting
22
Southern Endocrinology Associates
Mesquite, Texas, United States, 75149
Actively Recruiting
23
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
24
Endeavor Clinical Trials
San Antonio, Texas, United States, 78240
Actively Recruiting
25
Stroobants Cardiovascular Center
Lynchburg, Virginia, United States, 24501
Actively Recruiting
26
TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
Newport News, Virginia, United States, 23606
Actively Recruiting
27
Carilion Clinic
Roanoke, Virginia, United States, 24014
Actively Recruiting
28
Eastside Research Associates
Redmond, Washington, United States, 98052
Actively Recruiting
29
UW Medicine Diabetes Institute
Seattle, Washington, United States, 98109
Not Yet Recruiting
30
Ecogene-21
Chicoutimi, Canada, G7H 7K9
Actively Recruiting
31
C.I.C. Mauricie inc.
Trois-Rivières, Canada, G8T 7A1
Actively Recruiting
32
ARC Biosystems
Vancouver, Canada, V6Z 2H2
Actively Recruiting
33
Peking University Third Hospital
Beijing, China, 100091
Actively Recruiting
34
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Actively Recruiting
35
Guangdong Provincial People's Hospital
Guangzhou, China, 510000
Actively Recruiting
36
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, China, 471003
Actively Recruiting
37
Zhongshan Hospital,Fudan University
Shanghai, China, 200032
Actively Recruiting
38
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China, 221006
Actively Recruiting
39
The Institute of Medical Science, Asahi Life Foundation
Chūōku, Japan, 103-0002
Actively Recruiting
40
Takai Internal Medicine Clinic
Kamakura-shi, Japan, 247-0056
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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