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Solbinsiran injections to lower very high triglycerides

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 (Solbinsiran) in Adults With Severe Hypertriglyceridemia

Phase 2 Interventional Eli Lilly and Company · NCT07269210

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
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations40 sites (Phoenix, Arizona and 39 other locations)
Trial IDNCT07269210 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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 this trial is running

Phoenix, Arizona and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Severe Hypertriglyceridemia
Last reviewed 2026-06-13 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.