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Also known as LY3561774
Solbinsiran · 3 trials · 5 indications
Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| Solbinsiran | EXPERIMENTAL | Participants will receive solbinsiran subcutaneously (SC) |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| LY3561774 100 mg | EXPERIMENTAL | Participants received 100 milligram (mg) LY3561774 subcutaneously (SC) on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360. |
| LY3561774 400 mg | EXPERIMENTAL | Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360. |
| LY3561774 800 mg | EXPERIMENTAL | Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360. |
| LY3561774 (Part A) | EXPERIMENTAL | Single ascending doses of LY3561774 administered subcutaneously (SC). |
| LY3561774 (Part B) | EXPERIMENTAL | Repeat doses of LY3561774 administered SC. |
| LY3561774 (Part C) | EXPERIMENTAL | Single doses of LY3561774 administered SC in Japanese Participants. |
| Placebo (Part A, B & C) | PLACEBO_COMPARATOR | Placebo administered SC. |
| Name | Type | Description |
|---|---|---|
| Solbinsiran | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| LY3561774 | DRUG | Administered SC |
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 kil...
Solbinsiran is an investigational RNA therapy being developed by Eli Lilly and Company for severe hypertriglyceridemia, a metabolic condition marked by very high blood triglyceride levels. It is a small interfering RNA (siRNA) designed to target APOC3 and is currently in Phase 2 clinical development. It is not yet approved for any indication.
Solbinsiran is being studied as a treatment for severe hypertriglyceridemia, a condition characterized by markedly elevated triglyceride levels in the blood. The Phase 2 trial enrolls adults with this condition across the United States, Canada, China, and Japan. Solbinsiran remains investigational and has not been approved for clinical use.
Solbinsiran targets APOC3, the gene encoding apolipoprotein C-III. As a small interfering RNA (siRNA) therapy, it is designed to reduce APOC3 expression. Lowering apolipoprotein C-III is the intended mechanism for reducing triglyceride levels in patients with severe hypertriglyceridemia. The drug is in Phase 2 development.
Solbinsiran is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is running the Phase 2 clinical program evaluating the siRNA therapy in patients with severe hypertriglyceridemia. The asset is also referenced in trial documentation under the code LY3561774.
Solbinsiran is in Phase 2 clinical development. It is an investigational siRNA therapy for severe hypertriglyceridemia and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 study is currently recruiting participants and has an planned enrollment of 60 patients.
Solbinsiran is being evaluated in one active Phase 2 trial, NCT07269210, titled A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia. The trial is recruiting approximately 60 adults aged 18 and older across the United States, Canada, China, and Japan. It is randomized, double-blind, and placebo-controlled.