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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07207811 | CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis | PHASE3 | RECRUITING | 1,280 | — | — | Oct 2, 2025 | Jun 29, 2029 | May 27, 2026 | 290 | United States, Argentina +18 |
| NCT06260709 | A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis | PHASE2 | ACTIVE NOT_RECRUITING | 80 | — | — | Feb 20, 2024 | Aug 15, 2028 | Nov 25, 2025 | 35 | United States, Canada +8 |
| NCT05442047 | A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis | PHASE2 | COMPLETED | 105 | — | — | Aug 2, 2022 | May 13, 2025 | Feb 17, 2026 | 39 | United States, Canada +8 |
Measured as count of events.
Measured as events.
Measured in Meters
Measured in Percentage
| Arm | Type | Description |
|---|---|---|
| NNC6019-0001 | EXPERIMENTAL | Participants will receive NNC6019-0001 intravenously (IV). Participants will also have the option to continue any Standard of care (SoC) treatments as recommended by their medical health professional. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to NNC6019-0001 IV. Participants will also have the option to continue any SoC treatments as recommended by their medical health professional. |
| NNC6019-0001, Dose 1 | EXPERIMENTAL | Participants will receive dose 1 intravenous (i.v.) infusion of NNC6019-0001 every 4 weeks (Q4W) added to standard of care until week 52. |
| NNC6019-0001, Dose 2 | EXPERIMENTAL | Participants will receive dose 2 i.v. infusion of NNC6019-0001 Q4W added to standard of care until week 52. |
| Name | Type | Description |
|---|---|---|
| NNC6019-0001 | DRUG | NNC6019-0001 will be administered IV. |
| Placebo (NNC6019-0001) | DRUG | Placebo matched to NNC6019-0001 will be administered IV. |
Inclusion Criteria: * Male or female. * Age 18 years or above at the time of signing the informed consent. * Have an established diagnosis of ATTR-CM (wild-type ATTR \[ATTRwt\] or variant ATTR \[ATTRv\]), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF. No...