A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
SOLARIS-1
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 (Solbinsiran) in Adults With Severe Hypertriglyceridemia
2 other identifiers
interventional
60
4 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2025
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2025
CompletedFirst Posted
Study publicly available on registry
December 8, 2025
CompletedStudy Start
First participant enrolled
December 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 22, 2026
April 1, 2026
1.2 years
November 26, 2025
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Triglycerides
Baseline, Weeks 16-24 (Time-Average)
Secondary Outcomes (4)
Change from Baseline in Angiopoietin-like-3 (ANGPTL3)
Baseline, Week 24
Change from Baseline in Very-Low-Density Lipoprotein-Cholesterol (VLDL-C)
Baseline, Week 24
Change from Baseline in Non-High-Density Lipoprotein-Cholesterol (non-HDL-C)
Baseline, Week 24
Pharmacokinetics (PK): Steady State Area Under the Concentration Curve from Hour 0 to Infinity (AUC 0-∞)
Week 0: 0.5 hour (hr) and 4 to 9 hr postdose, Week 12: 24 to 36 hr postdose
Study Arms (2)
Solbinsiran
EXPERIMENTALParticipants will receive solbinsiran subcutaneously (SC)
Placebo
PLACEBO COMPARATORParticipants will receive placebo SC
Interventions
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
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, Inc.
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2025
First Posted
December 8, 2025
Study Start
December 8, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.