A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
ConditionSevere Hypertriglyceridemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Solbinsiran
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov