Solbinsiran injections to lower very high triglycerides
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
Run by Eli Lilly and Company · NCT07269210 · Data updated 2026-11-12
This trial will test whether two injections of solbinsiran can lower very high triglyceride levels in adults with severe hypertriglyceridemia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 41 sites (Phoenix, Arizona and 40 other locations) |
| Status | Recruiting |
| Started | December 8, 2025 |
| Main results expected | March 2027 |
| Study ends | August 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07269210 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with severe hypertriglyceridemia (fasting triglycerides ≥500 mg/dL confirmed twice), BMI 18.5–45 kg/m2, who can attend study visits and do not meet exclusion criteria such as recent major cardiovascular events or genetically confirmed familial chylomicronemia syndrome.
✕Probably not a fit
People with genetically confirmed familial chylomicronemia syndrome, recent major atherosclerotic cardiovascular events, recent chronic alcohol abuse, or a history/planned use of gene therapy are excluded and would not be expected to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 study enrolls adults with severe hypertriglyceridemia (fasting triglycerides ≥500 mg/dL confirmed on two separate screening visits) and a BMI of 18.5–45 kg/m2 to receive two subcutaneous injections of solbinsiran or placebo. The trial compares changes in triglycerides and other lipid measures versus placebo while closely monitoring safety. Key exclusions include recent major atherosclerotic cardiovascular events, genetically confirmed familial chylomicronemia syndrome, prior or planned gene therapy, and recent chronic alcohol abuse. The study is sponsored by Eli Lilly and conducted at multiple U.S. clinical research sites.
Why it matters
Potential benefit: If successful, solbinsiran could substantially lower triglyceride levels and reduce the risk of pancreatitis and other complications in people with severe hypertriglyceridemia.
How similar studies have gone: Other lipid-lowering RNA or antisense therapies (for example APOC3-targeting drugs) have produced substantial triglyceride reductions in earlier trials, suggesting the approach can work, but solbinsiran's effect in this specific population remains to be proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Ecogene-21
Chicoutimi, Canada Recruiting -
C.I.C. Mauricie inc.
Trois-Rivières, Canada Recruiting -
ARC Biosystems
Vancouver, Canada Recruiting -
Peking University Third Hospital
Beijing, China Recruiting -
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, China Recruiting -
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China Recruiting
Show 35 more locations
-
Onyx Clinical Research
Phoenix, Arizona, United States Completed -
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, United States Completed -
National Heart Institute
Beverly Hills, California, United States Completed -
Ark Clinical Research
Long Beach, California, United States Active not recruiting -
Catalina Research Institute, LLC
Montclair, California, United States Active not recruiting -
Valley Clinical Trials, LLC dba Flourish Research
Northridge, California, United States Active not recruiting -
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States Completed -
Northeast Research Institute - Downtown Office
Jacksonville, Florida, United States Active not recruiting -
Novera Clinical Research
Miami, Florida, United States Active not recruiting -
Inpatient Research Clinic
Miami Lakes, Florida, United States Active not recruiting -
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States Completed -
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States Active not recruiting -
Investigators Research Group
Brownsburg, Indiana, United States Active not recruiting -
Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
Covington, Kentucky, United States Active not recruiting -
Flourish Research - Bowie
Bowie, Maryland, United States Completed -
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States Completed -
AB Clinical Trials
Las Vegas, Nevada, United States Completed -
Clinical Research of Philadelphia
Pennington, New Jersey, United States Active not recruiting -
Weill Cornell Medical College
New York, New York, United States Completed -
Icahn School of Medicine at Mount Sinai
New York, New York, United States Active not recruiting -
Cardiovascular Specialists of Willowbrook
Houston, Texas, United States Active not recruiting -
Southern Endocrinology Associates
Mesquite, Texas, United States Active not recruiting -
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States Completed -
Endeavor Clinical Trials
San Antonio, Texas, United States Completed -
Stroobants Cardiovascular Center
Lynchburg, Virginia, United States Completed -
TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
Newport News, Virginia, United States Active not recruiting -
Carilion Clinic
Roanoke, Virginia, United States Active not recruiting -
Eastside Research Associates
Redmond, Washington, United States Active not recruiting -
UW Medicine Diabetes Institute
Seattle, Washington, United States Active not recruiting -
Sichuan Provincial People's Hospital
Chengdu, China Active not recruiting -
Guangdong Provincial People's Hospital
Guangzhou, China Active not recruiting -
Zhongshan Hospital,Fudan University
Shanghai, China Active not recruiting -
The Institute of Medical Science, Asahi Life Foundation
Chūōku, Japan Active not recruiting -
Takai Internal Medicine Clinic
Kamakura-shi, Japan Active not recruiting -
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Japan Completed
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 317-615-4559
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ion775 for high triglyceride levels: safety, tolerability, and how well it works
A drug called ION775 is being tested to see if it can safely lower fasting triglycerides in adults with hypertriglyceridemia or severe hypertriglyceridemia who are already on standard lipid medicines.
-
Plozasiran for adults with severe high triglycerides at risk of acute pancreatitis
This trial will test whether plozasiran injections every three months can lower triglycerides and reduce pancreatitis risk in adults with severe high triglycerides who have had multiple recent pancreatitis attacks.
-
EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes
This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.
-
Abemaciclib in healthy adults: comparing tablet and granule forms to see how they enter the bloodstream
This study tests different oral forms of abemaciclib in healthy volunteers to see how much and how fast the drug gets into the blood and what side effects occur.
-
Weekly tirzepatide vs placebo for pediatric obesity (6 to <12 years)
This study tests whether weekly tirzepatide can help children aged 6 to under 12 with obesity, in addition to healthy lifestyle guidance.
-
Testing LY4329090 in adults with overweight or obesity who are otherwise healthy
This study tests how LY4329090 works in adults with overweight or obesity who are otherwise healthy to see if it is tolerated and what side effects might occur.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.