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NCT Number: NCT07269210

A Study of Solbinsiran (LY3561774) in Participants 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.

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Key information

Conditions

Severe Hypertriglyceridemia Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ecogene-21, Chicoutimi, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solbinsiran

Drug

Administered SC

Other names: LY3561774

Placebo

Drug

Administered SC

Primary outcomes

  1. Change from Baseline in Triglycerides

    Time frame: Baseline, Weeks 16-24 (Time-Average)

Secondary outcomes

  1. Change from Baseline in Angiopoietin-like-3 (ANGPTL3)

    Time frame: Baseline, Week 24

  2. Change from Baseline in Very-Low-Density Lipoprotein-Cholesterol (VLDL-C)

    Time frame: Baseline, Week 24

  3. Change from Baseline in Non-High-Density Lipoprotein-Cholesterol (non-HDL-C)

    Time frame: Baseline, Week 24

  4. Pharmacokinetics (PK): Steady State Area Under the Concentration Curve from Hour 0 to Infinity (AUC 0-∞)

    Time frame: Week 0: 0.5 hour (hr) and 4 to 9 hr postdose, Week 12: 24 to 36 hr postdose

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: SOLARIS-1

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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