Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05256654 | A Study of LY3561774 in Participants With Mixed Dyslipidemia | PHASE2 | COMPLETED | 205 | — | — | Jul 20, 2022 | May 23, 2024 | Mar 17, 2025 | 41 | United States, Argentina +5 |
| NCT04644809 | A Study of LY3561774 in Participants With Dyslipidemia | PHASE1 | COMPLETED | 74 | — | — | Nov 30, 2020 | May 17, 2022 | Aug 10, 2022 | 5 | United States |
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...