Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Solbinsiran
LY3561774 · 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...
LY3561774 is an investigational RNA therapy being developed by Eli Lilly and Company for dyslipidemias, a group of conditions involving abnormal lipid levels in the blood. It is in Phase 2 clinical development and has been studied in placebo-controlled, double-blind trials. It is not yet approved for any indication.
LY3561774 is being studied for the treatment of dyslipidemias, including mixed dyslipidemia and related lipid metabolism disorders. Clinical trials have enrolled adults 18 years and older with these conditions. It remains investigational and has not been approved for commercial use.
LY3561774 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating the drug in patients with dyslipidemias.
LY3561774 is in Phase 2 clinical development. Two trials have been completed: a Phase 2 study in mixed dyslipidemia and a Phase 1 study in dyslipidemia. No active trials are currently listed, and the drug is investigational rather than approved.
LY3561774 has been evaluated in two completed trials. NCT05256654 was a Phase 2 study in 205 participants with mixed dyslipidemia across the United States, Argentina, Canada, Japan, Mexico, Poland, and Turkey. NCT04644809 was a Phase 1 study in 74 participants with dyslipidemia in the United States.
LY3561774 is an RNA therapy, a modality that uses RNA-based mechanisms to modulate biological targets. It is being developed for dyslipidemias, conditions characterized by abnormal blood lipid levels. The specific molecular target of LY3561774 has not been disclosed in the available program information.