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

August 21, 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • 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 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
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Limin Tian
      • Guangzhou, China, 510000
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Principal Investigator:
          • Zhi-cheng JING
      • Luoyang Shi, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science &Technology
        • Principal Investigator:
          • Hongwei Jiang
        • Contact:
          • Phone Number: 13653880139
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital,Fudan University
        • Principal Investigator:
          • Zhen Wang
      • 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
        • Active, not recruiting
        • Medical Corporation Heishinkai OCROM Clinic
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Not yet recruiting
        • Onyx Clinical Research
        • Contact:
          • Phone Number: 602-730-9500
        • Principal Investigator:
          • Kevin Berman
      • Tucson, Arizona, United States, 85741
        • Recruiting
        • Synexus Clinical Research US, Inc./Orange Grove Family Practice
        • Principal Investigator:
          • Kevin Pounds
        • Contact:
          • Phone Number: 520-333-4515
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • National Heart Institute
        • Contact:
          • Phone Number: 310-289-9955
        • Principal Investigator:
          • Norman Lepor
      • Long Beach, California, United States, 90815
        • Recruiting
        • Ark Clinical Research
        • Principal Investigator:
          • Apinya Vutikullird
        • Contact:
          • Phone Number: 562-997-1000
      • Montclair, California, United States, 91763
        • Recruiting
        • Catalina Research Institute, LLC
        • Contact:
          • Phone Number: 909-590-8409
        • Principal Investigator:
          • Rizwana Mohseni
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials, LLC dba Flourish Research
        • Contact:
          • Phone Number: 818-678-4900
        • Principal Investigator:
          • Mehrdad Ariani
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Recruiting
        • CMR of Greater New Haven, LLC
        • Principal Investigator:
          • Jillian Reid
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • Northeast Research Institute - Downtown Office
        • Principal Investigator:
          • Firas Warda
        • Contact:
          • Phone Number: 904-541-8225
      • Miami, Florida, United States, 33135
        • Recruiting
        • Novera Clinical Research
        • Contact:
          • Phone Number: 305-631-0619
        • Principal Investigator:
          • Romulo Clavelo
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Inpatient Research Clinic
        • Principal Investigator:
          • Alexis Gutierrez
        • Contact:
          • Phone Number: 786-502-4303
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Clinical Site Partners, LLC dba Flourish Research
        • Contact:
          • Phone Number: 407-740-8078
        • Principal Investigator:
          • Monica Aggarwal
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Great Lakes Clinical Trials - Ravenswood
        • Contact:
          • Phone Number: 773-275-3500
        • Principal Investigator:
          • Manish Jain
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Recruiting
        • Investigators Research Group
        • Contact:
          • Phone Number: 317-852-8280
        • Principal Investigator:
          • Kenneth Maynard
    • Kentucky
      • Covington, Kentucky, United States, 41011
        • Recruiting
        • Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
        • Principal Investigator:
          • Wael Eid
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Recruiting
        • Flourish Research - Bowie
        • Principal Investigator:
          • Sara Collins
        • Contact:
          • Phone Number: 410-824-1341
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Chan Medical School
        • Principal Investigator:
          • Khanh-Van Tran
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • AB Clinical Trials
        • Principal Investigator:
          • Atoya Adams
        • Contact:
          • Phone Number: 702-233-4700 ext 2
    • New Jersey
      • Pennington, New Jersey, United States, 08534
        • Recruiting
        • Clinical Research of Philadelphia
        • Contact:
          • Phone Number: 215-676-6696
        • Principal Investigator:
          • Taher Modarressi
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • Robert Rosenson
        • Contact:
          • Phone Number: 212-241-9101
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medical College
        • Principal Investigator:
          • Samuel Kim
        • Contact:
          • Phone Number: 646-962-5558
    • Texas
      • Houston, Texas, United States, 77070
        • Recruiting
        • Cardiovascular Specialists of Willowbrook
        • Principal Investigator:
          • Aditya Samal
        • Contact:
          • Phone Number: 949-491-0710
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • Southern Endocrinology Associates
        • Contact:
          • Phone Number: 214-693-0904
        • Principal Investigator:
          • Sumana Gangi
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Endeavor Clinical Trials
        • Principal Investigator:
          • Nitendra Agarwal
        • Contact:
          • Phone Number: 518-428-6859
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • American Research Corporation at Texas Liver Institute
        • Contact:
          • Phone Number: 210-253-3426
        • Principal Investigator:
          • Eric Lawitz
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Recruiting
        • Stroobants Cardiovascular Center
        • Principal Investigator:
          • Thomas Meyer
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
        • Contact:
          • Phone Number: 757-232-8836
        • Principal Investigator:
          • Linda Schneider
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Clinic
        • Principal Investigator:
          • Bryant Self
    • Washington
      • Redmond, Washington, United States, 98052
        • Recruiting
        • Eastside Research Associates
        • Contact:
          • Phone Number: 425-869-6828
        • Principal Investigator:
          • Christopher Price
      • Seattle, Washington, United States, 98109
        • Recruiting
        • UW Medicine Diabetes Institute
        • Principal Investigator:
          • Savitha Subramanian

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo SC
Drug: Placebo
Administered SC
Experimental: Solbinsiran
Participants will receive solbinsiran subcutaneously (SC)
Drug: Solbinsiran
Administered SC
Other Names:
  • LY3561774

What is the study measuring?

Primary Outcome Measures

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

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

Eli Lilly and Company

Investigators

  • 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)

December 8, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

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