Severe HypertriglyceridemiaPhase 2SOLARIS-1NCT07269210
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
A Phase 2 study testing Solbinsiran in people with Severe Hypertriglyceridemia, run by Eli Lilly and Company at 41 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Hypertriglyceridemia
- What is being tested?
- Solbinsiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 41 sitesin 4 countries
- Study dates
- 8 Dec 2025to Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
41 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
41 sites in 4 countries
United States29 sites
- Completed
National Heart Institute
Beverly Hills, California, 90211
- Completed
Flourish Research - Bowie
Bowie, Maryland, 20715
- Active, not recruiting
Investigators Research Group
Brownsburg, Indiana, 46112
- Active, not recruiting
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
- Active, not recruiting
Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
Covington, Kentucky, 41011
- Completed
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517
- Active, not recruiting
Cardiovascular Specialists of Willowbrook
Houston, Texas, 77070
- Active, not recruiting
Northeast Research Institute - Downtown Office
Jacksonville, Florida, 32204
- Completed
AB Clinical Trials
Las Vegas, Nevada, 89119
- Active, not recruiting
Ark Clinical Research
Long Beach, California, 90815
- Completed
Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501
- Active, not recruiting
Southern Endocrinology Associates
Mesquite, Texas, 75149
- Active, not recruiting
Novera Clinical Research
Miami, Florida, 33135
- Active, not recruiting
Inpatient Research Clinic
Miami Lakes, Florida, 33014
- Active, not recruiting
Catalina Research Institute, LLC
Montclair, California, 91763
- Completed
Weill Cornell Medical College
New York, New York, 10021
- Active, not recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Active, not recruiting
TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
Newport News, Virginia, 23606
- Active, not recruiting
Valley Clinical Trials, LLC dba Flourish Research
Northridge, California, 91325
- Active, not recruiting
Clinical Research of Philadelphia
Pennington, New Jersey, 08534
- Completed
Onyx Clinical Research
Phoenix, Arizona, 85014
- Active, not recruiting
Eastside Research Associates
Redmond, Washington, 98052
- Active, not recruiting
Carilion Clinic
Roanoke, Virginia, 24014
- Completed
American Research Corporation at Texas Liver Institute
San Antonio, Texas, 78215
- Completed
Endeavor Clinical Trials
San Antonio, Texas, 78240
- Active, not recruiting
UW Medicine Diabetes Institute
Seattle, Washington, 98109
- Completed
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, 85741
- Completed
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789
- Completed
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
China6 sites, 6 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100091
13810103532
Dan Zhu
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
Limin Tian
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, 510000
Zhi-cheng JING
- Recruiting
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471003
13653880139
Hongwei Jiang
- Recruiting
Zhongshan Hospital,Fudan University
Shanghai, 200032
Zhen Wang
- Recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221006
Hong Zhu
Canada3 sites, 3 recruiting
- Recruiting
Ecogene-21
Chicoutimi, G7H 7K9
418-545-1252
Daniel Gaudet
- Recruiting
C.I.C. Mauricie inc.
Trois-Rivières, G8T 7A1
8193731128
Imen Mekrazi
- Recruiting
ARC Biosystems
Vancouver, V6Z 2H2
Liam Brunham
Japan3 sites
- Active, not recruiting
The Institute of Medical Science, Asahi Life Foundation
Chūōku, 103-0002
- Active, not recruiting
Takai Internal Medicine Clinic
Kamakura-shi, 247-0056
- Completed
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, 565-0853
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 (Solbinsiran) in Adults With Severe Hypertriglyceridemia
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.
- Conditions
- Severe Hypertriglyceridemia
- Being tested
- Solbinsiran, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolbinsiranDrug
Also called LY3561774
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Solbinsiran | Experimental | Participants will receive solbinsiran subcutaneously (SC) Receives: Drug: Solbinsiran |
| Placebo | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Triglycerides
Measured: Baseline, Weeks 16-24 (Time-Average)
Secondary outcomes (4)
Change from Baseline in Angiopoietin-like-3 (ANGPTL3)
Measured: Baseline, Week 24
Change from Baseline in Very-Low-Density Lipoprotein-Cholesterol (VLDL-C)
Measured: Baseline, Week 24
Change from Baseline in Non-High-Density Lipoprotein-Cholesterol (non-HDL-C)
Measured: Baseline, Week 24
Pharmacokinetics (PK): Steady State Area Under the Concentration Curve from Hour 0 to Infinity (AUC 0-∞)
Measured: Week 0: 0.5 hour (hr) and 4 to 9 hr postdose, Week 12: 24 to 36 hr postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start8 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269210
- Sponsor's protocol ID
- 27775
- Other IDs
- J3F-MC-EZCC
- Acronym
- SOLARIS-1
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.