A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia (SOLARIS-1)

November 3, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • Canada
      • Chicoutimi, Canada, G7H 7K9
        • Recruiting
        • Ecogene-21
        • Principal Investigator:
          • Daniel Gaudet
        • Contact:
          • Phone Number: 418-545-1252
      • Trois-Rivières, Canada, G8T 7A1
        • Recruiting
        • C.I.C. Mauricie inc.
        • Contact:
          • Phone Number: 8193731128
        • Principal Investigator:
          • Imen Mekrazi
      • Vancouver, Canada, V6Z 2H2
        • Recruiting
        • ARC Biosystems
        • Principal Investigator:
          • Liam Brunham
  • China
      • Beijing, China, 100091
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Dan Zhu
        • Contact:
          • Phone Number: 13810103532
      • Chengdu, China, 610072
        • Active, not recruiting
        • Sichuan Provincial People's Hospital
      • Guangzhou, China, 510000
        • Active, not recruiting
        • Guangdong Provincial People's Hospital
      • Luoyang, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science &Technology
        • Principal Investigator:
          • Hongwei Jiang
        • Contact:
          • Phone Number: 13653880139
      • Shanghai, China, 200032
        • Active, not recruiting
        • Zhongshan Hospital,Fudan University
      • Xuzhou, China, 221006
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical College
        • Principal Investigator:
          • Hong Zhu
  • Japan
      • Chūōku, Japan, 103-0002
        • Active, not recruiting
        • The Institute of Medical Science, Asahi Life Foundation
      • Kamakura-shi, Japan, 247-0056
        • Active, not recruiting
        • Takai Internal Medicine Clinic
      • Suita-shi, Japan, 565-0853
        • Completed
        • Medical Corporation Heishinkai OCROM Clinic
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Completed
        • Onyx Clinical Research
      • Tucson, Arizona, United States, 85741
        • Completed
        • Synexus Clinical Research US, Inc./Orange Grove Family Practice
    • California
      • Beverly Hills, California, United States, 90211
        • Completed
        • National Heart Institute
      • Long Beach, California, United States, 90815
        • Active, not recruiting
        • Ark Clinical Research
      • Montclair, California, United States, 91763
        • Active, not recruiting
        • Catalina Research Institute, LLC
      • Northridge, California, United States, 91325
        • Active, not recruiting
        • Valley Clinical Trials, LLC dba Flourish Research
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Completed
        • CMR of Greater New Haven, LLC
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Active, not recruiting
        • Northeast Research Institute - Downtown Office
      • Miami, Florida, United States, 33135
        • Active, not recruiting
        • Novera Clinical Research
      • Miami Lakes, Florida, United States, 33014
        • Active, not recruiting
        • Inpatient Research Clinic
      • Winter Park, Florida, United States, 32789
        • Completed
        • Clinical Site Partners, LLC dba Flourish Research
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Active, not recruiting
        • Great Lakes Clinical Trials - Ravenswood
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Active, not recruiting
        • Investigators Research Group
    • Kentucky
      • Covington, Kentucky, United States, 41011
        • Active, not recruiting
        • Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Completed
        • Flourish Research - Bowie
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Completed
        • University of Massachusetts Chan Medical School
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Completed
        • AB Clinical Trials
    • New Jersey
      • Pennington, New Jersey, United States, 08534
        • Active, not recruiting
        • Clinical Research of Philadelphia
    • New York
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10021
        • Completed
        • Weill Cornell Medical College
    • Texas
      • Houston, Texas, United States, 77070
        • Active, not recruiting
        • Cardiovascular Specialists of Willowbrook
      • Mesquite, Texas, United States, 75149
        • Active, not recruiting
        • Southern Endocrinology Associates
      • San Antonio, Texas, United States, 78215
        • Completed
        • American Research Corporation at Texas Liver Institute
      • San Antonio, Texas, United States, 78240
        • Completed
        • Endeavor Clinical Trials
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Completed
        • Stroobants Cardiovascular Center
      • Newport News, Virginia, United States, 23606
        • Active, not recruiting
        • TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
      • Roanoke, Virginia, United States, 24014
        • Active, not recruiting
        • Carilion Clinic
    • Washington
      • Redmond, Washington, United States, 98052
        • Active, not recruiting
        • Eastside Research Associates
      • Seattle, Washington, United States, 98109
        • Active, not recruiting
        • UW Medicine Diabetes Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Solbinsiran

Participants will receive solbinsiran subcutaneously (SC)
Drug: Solbinsiran

Administered SC

Other Names:
  • LY3561774
Placebo Comparator: Placebo

Participants will receive placebo SC
Drug: Placebo

Administered SC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Triglycerides
Time Frame: Baseline, Weeks 16-24 (Time-Average)
Baseline, Weeks 16-24 (Time-Average)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Angiopoietin-like-3 (ANGPTL3)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Very-Low-Density Lipoprotein-Cholesterol (VLDL-C)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Non-High-Density Lipoprotein-Cholesterol (non-HDL-C)
Time Frame: Baseline, Week 24
Baseline, Week 24
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
Week 0: 0.5 hour (hr) and 4 to 9 hr postdose, Week 12: 24 to 36 hr postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27775
  • J3F-MC-EZCC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings