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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07235046 | A Study of DII235 in Adults With Elevated Lipoprotein(a) | PHASE2 | RECRUITING | 200 | — | — | Dec 2, 2025 | Apr 25, 2028 | Jun 8, 2026 | 66 | United States, China +2 |
Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 180, defined as the area under the curve (AUC) between the Day 60 Visit date and the Day 180 Visit date, divided by the duration between the two visit dates.
Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 360, defined as the area under the curve (AUC) between the Day 60 visit date and the Day 360 visit date, divided by the duration between the two visit dates.
Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 360, defined as the area under the curve (AUC) between the Day 60 visit date and the Day 360 visit date, divided by the duration between the two visit dates.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | PLACEBO_COMPARATOR | Placebo |
| Arm 2 | EXPERIMENTAL | DII235 dose 1 |
| Arm 3 | EXPERIMENTAL | DII235 dose 2 |
| Arm 4 | EXPERIMENTAL | DII235 dose 3 |
| Arm 5 | EXPERIMENTAL | DII235 dose 4 |
| Name | Type | Description |
|---|---|---|
| DII235 | DRUG | Solution for injection |
| Saline | DRUG | solution for injection |
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female participants 18 to 80 years of age (inclusive) at the screening. * Lp(a) ≥ 150 nmol/L at screening, measured at the central laboratory. * Participants with evidence of atheroscleroti...