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

NCT ID: NCT07269210

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Solbinsiran

Participants will receive solbinsiran subcutaneously (SC)

Group Type EXPERIMENTAL

Solbinsiran

Intervention Type DRUG

Administered SC

Placebo

Participants will receive placebo SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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Solbinsiran

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3561774

Eligibility Criteria

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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 history of acute pancreatitis within 12 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Axsendo Clinical Research - Peak Heart & Vascular - Phoenix

Phoenix, Arizona, United States

Site Status NOT_YET_RECRUITING

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

Tucson, Arizona, United States

Site Status RECRUITING

National Heart Institute

Beverly Hills, California, United States

Site Status RECRUITING

Ark Clinical Research

Long Beach, California, United States

Site Status RECRUITING

Catalina Research Institute, LLC

Montclair, California, United States

Site Status NOT_YET_RECRUITING

Valley Clinical Trials, Inc.

Northridge, California, United States

Site Status RECRUITING

CMR of Greater New Haven, LLC

Hamden, Connecticut, United States

Site Status RECRUITING

Northeast Research Institute - Downtown Office

Jacksonville, Florida, United States

Site Status RECRUITING

Novera Clinical Research

Miami, Florida, United States

Site Status RECRUITING

Inpatient Research Clinic

Miami Lakes, Florida, United States

Site Status NOT_YET_RECRUITING

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, United States

Site Status NOT_YET_RECRUITING

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Site Status RECRUITING

Investigators Research Group

Brownsburg, Indiana, United States

Site Status NOT_YET_RECRUITING

Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital

Covington, Kentucky, United States

Site Status NOT_YET_RECRUITING

Flourish Research - Bowie

Bowie, Maryland, United States

Site Status RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Site Status NOT_YET_RECRUITING

AB Clinical Trials

Las Vegas, Nevada, United States

Site Status RECRUITING

Clinical Research of Philadelphia

Pennington, New Jersey, United States

Site Status RECRUITING

Weill Cornell Medical College

New York, New York, United States

Site Status NOT_YET_RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status NOT_YET_RECRUITING

Cardiovascular Specialists of Willowbrook

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Southern Endocrinology Associates

Mesquite, Texas, United States

Site Status RECRUITING

American Research Corporation at Texas Liver Institute

San Antonio, Texas, United States

Site Status RECRUITING

Endeavor Clinical Trials

San Antonio, Texas, United States

Site Status RECRUITING

Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

Site Status RECRUITING

TPMG (Tidewater Physicians Multispecialty Group) Clinical Research

Newport News, Virginia, United States

Site Status RECRUITING

Carilion Clinic

Roanoke, Virginia, United States

Site Status NOT_YET_RECRUITING

Eastside Research Associates

Redmond, Washington, United States

Site Status NOT_YET_RECRUITING

UW Medicine Diabetes Institute

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Ecogene-21

Chicoutimi, , Canada

Site Status NOT_YET_RECRUITING

C.I.C. Mauricie inc.

Trois-Rivières, , Canada

Site Status NOT_YET_RECRUITING

ARC Biosystems

Vancouver, , Canada

Site Status NOT_YET_RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status NOT_YET_RECRUITING

Sichuan Provincial People's Hospital

Chengdu, , China

Site Status NOT_YET_RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, , China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, , China

Site Status NOT_YET_RECRUITING

Zhongshan Hospital,Fudan University

Shanghai, , China

Site Status NOT_YET_RECRUITING

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, , China

Site Status NOT_YET_RECRUITING

The Institute of Medical Science, Asahi Life Foundation

Chūōku, , Japan

Site Status NOT_YET_RECRUITING

Takai Internal Medicine Clinic

Kamakura-shi, , Japan

Site Status NOT_YET_RECRUITING

Countries

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United States Canada China Japan

Central Contacts

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

Role: CONTACT

317-615-4559

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Facility Contacts

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Role: primary

602-730-9500

Role: primary

520-333-4515

Role: primary

310-289-9955

Role: primary

562-997-1000

Role: primary

909-590-8409

Role: primary

818-678-4900

Role: primary

904-541-8225

Role: primary

305-631-0619

Role: primary

786-502-4303

Role: primary

407-740-8078

Role: primary

773-275-3500

Role: primary

317-852-8280

Role: primary

410-824-1341

Role: primary

702-233-4700 ext 2

Role: primary

215-676-6696

Role: primary

646-962-5558

Role: primary

212-241-9101

Role: primary

949-491-0710

Role: primary

214-693-0904

Role: primary

210-253-3426

Role: primary

518-428-6859

Role: primary

757-232-8836

Role: primary

425-869-6828

Role: primary

418-545-1252

Role: primary

8193731128

Role: primary

13810103532

Role: primary

13653880139

Role: primary

81120023812

Role: primary

81120023812

Related Links

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https://trials.lilly.com/en-US/trial/670675

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

Other Identifiers

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J3F-MC-EZCC

Identifier Type: OTHER

Identifier Source: secondary_id

27775

Identifier Type: -

Identifier Source: org_study_id

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