Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DII235 · 1 trial · 1 indication
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...
DII235 is an investigational small molecule being developed for the treatment of lipoprotein disorder, specifically for adults with elevated lipoprotein(a). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
DII235 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for the treatment of lipoprotein disorder.
DII235 is currently in Phase 2 clinical development. It is an investigational drug being studied for the treatment of lipoprotein disorder in adults with elevated lipoprotein(a). The drug has not yet been approved by regulatory authorities and remains in clinical testing.
DII235 is being evaluated in a Phase 2 clinical trial registered as NCT07235046, titled 'A Study of DII235 in Adults With Elevated Lipoprotein(a)'. This randomized, double-blind, placebo-controlled study has an enrollment of 234 participants and is active but not recruiting. The trial is being conducted in the United States, China, Germany, and Japan.
DII235 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of lipoprotein disorder. The drug is being studied in a randomized, double-blind, placebo-controlled trial, but has not yet received regulatory approval.