RECRUITINGPhase 2INTERVENTIONAL
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 (Solbinsiran) in Adults With Severe Hypertriglyceridemia
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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)
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Solbinsiran
Administered SC
DRUG
Placebo
Administered SC
Locations (20)
Axsendo Clinical Research - Peak Heart & Vascular - Phoenix
Phoenix, Arizona, United States
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, United States
National Heart Institute
Beverly Hills, California, United States
Ark Clinical Research
Long Beach, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States
Northeast Research Institute - Downtown Office
Jacksonville, Florida, United States
Novera Clinical Research
Miami, Florida, United States
Inpatient Research Clinic
Miami Lakes, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
Investigators Research Group
Brownsburg, Indiana, United States
Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
Covington, Kentucky, United States
Flourish Research - Bowie
Bowie, Maryland, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
AB Clinical Trials
Las Vegas, Nevada, United States
Clinical Research of Philadelphia
Pennington, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States