Recruiting
Phase 2

Solbinsiran

Sponsor:

Eli Lilly and Company

Code:

NCT07269210

Conditions

Severe Hypertriglyceridemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Solbinsiran

Placebo

Study Details

Brief summary:

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.

Conditions

Severe Hypertriglyceridemia

Study ID

NCT07269210

Start date

Dec 8, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Solbinsiran

Participants will receive solbinsiran subcutaneously (SC)

placebo comparator: Placebo

Participants will receive placebo SC

Interventions

Solbinsiran

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Change from Baseline in Triglycerides [ Time Frame: Baseline, Weeks 16-24 (Time-Average) ]

Central Contacts and Locations

Central contacts

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

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Synexus Clinical Research US, Inc./Orange Grove Family Practice

Recruiting

Tucson, Arizona, United States, 85741

Contacts

520-333-4515

Principal Investigator:

Kevin Pounds

National Heart Institute

Recruiting

Beverly Hills, California, United States, 90211

Contacts

310-289-9955

Principal Investigator:

Norman Lepor

Ark Clinical Research

Recruiting

Long Beach, California, United States, 90815

Contacts

562-997-1000

Principal Investigator:

Apinya Vutikullird

Catalina Research Institute, LLC

Recruiting

Montclair, California, United States, 91763

Contacts

909-590-8409

Principal Investigator:

Rizwana Mohseni

Valley Clinical Trials, LLC dba Flourish Research

Recruiting

Northridge, California, United States, 91325

Contacts

818-678-4900

Principal Investigator:

Mehrdad Ariani

CMR of Greater New Haven, LLC

Recruiting

Hamden, Connecticut, United States, 06517

Principal Investigator:

Jillian Reid

Northeast Research Institute - Downtown Office

Recruiting

Jacksonville, Florida, United States, 32204

Contacts

904-541-8225

Principal Investigator:

Firas Warda

Novera Clinical Research

Recruiting

Miami, Florida, United States, 33135

Contacts

305-631-0619

Principal Investigator:

Romulo Clavelo

Inpatient Research Clinic

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

786-502-4303

Principal Investigator:

Alexis Gutierrez

Clinical Site Partners, LLC dba Flourish Research

Recruiting

Winter Park, Florida, United States, 32789

Contacts

407-740-8078

Principal Investigator:

Monica Aggarwal

Great Lakes Clinical Trials - Ravenswood

Recruiting

Chicago, Illinois, United States, 60640

Contacts

773-275-3500

Principal Investigator:

Manish Jain

Investigators Research Group

Recruiting

Brownsburg, Indiana, United States, 46112

Contacts

317-852-8280

Principal Investigator:

Kenneth Maynard

Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital

Recruiting

Covington, Kentucky, United States, 41011

Principal Investigator:

Wael Eid

Flourish Research - Bowie

Recruiting

Bowie, Maryland, United States, 20715

Contacts

410-824-1341

Principal Investigator:

Sara Collins

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Principal Investigator:

Khanh-Van Tran

AB Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

702-233-4700 ext 2

Principal Investigator:

Atoya Adams

Clinical Research of Philadelphia

Recruiting

Pennington, New Jersey, United States, 08534

Contacts

215-676-6696

Principal Investigator:

Taher Modarressi

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Contacts

646-962-5558

Principal Investigator:

Samuel Kim

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

212-241-9101

Principal Investigator:

Robert Rosenson

Cardiovascular Specialists of Willowbrook

Recruiting

Houston, Texas, United States, 77070

Contacts

949-491-0710

Principal Investigator:

Aditya Samal

Southern Endocrinology Associates

Recruiting

Mesquite, Texas, United States, 75149

Contacts

214-693-0904

Principal Investigator:

Sumana Gangi

American Research Corporation at Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Contacts

210-253-3426

Principal Investigator:

Eric Lawitz

Endeavor Clinical Trials

Recruiting

San Antonio, Texas, United States, 78240

Contacts

518-428-6859

Principal Investigator:

Nitendra Agarwal

Stroobants Cardiovascular Center

Recruiting

Lynchburg, Virginia, United States, 24501

Principal Investigator:

Thomas Meyer

TPMG (Tidewater Physicians Multispecialty Group) Clinical Research

Recruiting

Newport News, Virginia, United States, 23606

Contacts

757-232-8836

Principal Investigator:

Linda Schneider

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Principal Investigator:

Bryant Self

Eastside Research Associates

Recruiting

Redmond, Washington, United States, 98052

Contacts

425-869-6828

Principal Investigator:

Christopher Price

UW Medicine Diabetes Institute

Recruiting

Seattle, Washington, United States, 98109

Principal Investigator:

Savitha Subramanian

Ecogene-21

Recruiting

Chicoutimi, Canada, G7H 7K9

Contacts

418-545-1252

Principal Investigator:

Daniel Gaudet

C.I.C. Mauricie inc.

Recruiting

Trois-Rivières, Canada, G8T 7A1

Contacts

8193731128

Principal Investigator:

Imen Mekrazi

ARC Biosystems

Recruiting

Vancouver, Canada, V6Z 2H2

Principal Investigator:

Liam Brunham

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.