Severe Hypertriglyceridemia
Conditions
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.
Interventions
DRUGSolbinsiran
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Triglycerides | Baseline, Weeks 16-24 (Time-Average) |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Angiopoietin-like-3 (ANGPTL3) | Baseline, Week 24 |
| Change from Baseline in Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) | Baseline, Week 24 |
| Change from Baseline in Non-High-Density Lipoprotein-Cholesterol (non-HDL-C) | Baseline, Week 24 |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Curve from Hour 0 to Infinity (AUC 0-∞) | Week 0: 0.5 hour (hr) and 4 to 9 hr postdose, Week 12: 24 to 36 hr postdose |
Countries
Canada, China, Japan, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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)
Eli Lilly and Company
Outcome results
None listed