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

Purpose

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.

Condition

  • Severe Hypertriglyceridemia

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Axsendo Clinical Research - Peak Heart & Vascular - Phoenix
Phoenix, Arizona 85014
Contact:
602-730-9500

Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona 85741
Contact:
520-333-4515

National Heart Institute
Beverly Hills, California 90211
Contact:
310-289-9955

Ark Clinical Research
Long Beach, California 90815
Contact:
562-997-1000

Catalina Research Institute, LLC
Montclair, California 91763
Contact:
909-590-8409

Valley Clinical Trials, Inc.
Northridge, California 91325
Contact:
818-678-4900

CMR of Greater New Haven, LLC
Hamden, Connecticut 06517

Northeast Research Institute - Downtown Office
Jacksonville, Florida 32204
Contact:
904-541-8225

Novera Clinical Research
Miami, Florida 33135
Contact:
305-631-0619

Inpatient Research Clinic
Miami Lakes, Florida 33014
Contact:
786-502-4303

Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida 32789
Contact:
407-740-8078

Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois 60640
Contact:
773-275-3500

Investigators Research Group
Brownsburg, Indiana 46112
Contact:
317-852-8280

Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
Covington, Kentucky 41011

Flourish Research - Bowie
Bowie, Maryland 20715
Contact:
410-824-1341

University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655

AB Clinical Trials
Las Vegas, Nevada 89119
Contact:
702-233-4700 ext 2

Clinical Research of Philadelphia
Pennington, New Jersey 08534
Contact:
215-676-6696

Weill Cornell Medical College
New York, New York 10021
Contact:
646-962-5558

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
212-241-9101

Cardiovascular Specialists of Willowbrook
Houston, Texas 77070
Contact:
949-491-0710

Southern Endocrinology Associates
Mesquite, Texas 75149
Contact:
214-693-0904

American Research Corporation at Texas Liver Institute
San Antonio, Texas 78215
Contact:
210-253-3426

Endeavor Clinical Trials
San Antonio, Texas 78240
Contact:
518-428-6859

Stroobants Cardiovascular Center
Lynchburg, Virginia 24501

TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
Newport News, Virginia 23606
Contact:
757-232-8836

Carilion Clinic
Roanoke, Virginia 24014

Eastside Research Associates
Redmond, Washington 98052
Contact:
425-869-6828

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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