Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3561774 · 2 trials · 4 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 |
|---|---|---|
| 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. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo 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 |
|---|---|---|
| LY3561774 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Have fasting triglycerides (TGs) within the range of 150 (1.69 millimole/liter (mmoL) to 499 milligram/deciliter (mg/dL) 2.26 to 5.64 millimole/liter (mmol/L) at screening. * Have fasting LDL-C ≥70 mg/dL (1.81 mmol/L) at screening. * Have non-HDL-C ≥ 130 mg/dL (3.36 mmol/L) at...
LY3561774 is an investigational small molecule being developed for dyslipidemias, a group of conditions characterized by abnormal levels of lipids in the blood. It is being studied in participants with mixed dyslipidemia and related lipid metabolism disorders. The drug is currently in Phase 2 clinical development and is not approved by the FDA.
LY3561774 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with dyslipidemias.
LY3561774 is in Phase 2 clinical development. It has completed a Phase 1 trial and a Phase 2 trial, both of which are finished. The drug remains investigational and has not received FDA approval. Its development is focused on treating dyslipidemias.
LY3561774 has been studied in two completed clinical trials. The first, NCT04644809, was a Phase 1 study in participants with dyslipidemia, enrolling 74 people in the United States. The second, NCT05256654, was a Phase 2 study in participants with mixed dyslipidemia, enrolling 205 people across multiple countries including the United States, Argentina, Canada, Japan, Mexico, Poland, and Turkey.
LY3561774 is the only name provided for this investigational drug. No alternative names or brand names have been associated with it in the available information. It is a small molecule being developed by Eli Lilly and Company for the treatment of dyslipidemias.