Clinical trial Recruiting at 6 sites Phase 2 Interventional Ages 18 and up

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

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations41 sites (Phoenix, Arizona and 40 other locations)
StatusRecruiting
StartedDecember 8, 2025
Main results expectedMarch 2027
Study endsAugust 2027
Registry record updatedNovember 4, 2026
Trial IDNCT07269210 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.