Approval Probability
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NNC6019-0001 · 3 trials · 1 indication
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| 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: 1. Male or female. 2. Age 18 years or above at the time of signing the informed consent. 3. 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. ...
NNC6019-0001, also known as coramitug, is an investigational small molecule being developed for the treatment of transthyretin amyloid cardiomyopathy (ATTR CM), a condition that causes heart failure due to the buildup of transthyretin protein in the heart. It is currently in Phase 3 clinical development.
NNC6019-0001 targets transthyretin, the protein that misfolds and accumulates in the heart in transthyretin amyloid cardiomyopathy (ATTR CM). By interacting with this protein, the drug aims to address the underlying cause of the disease. It is being studied in patients with heart failure due to ATTR amyloidosis.
NNC6019-0001 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with transthyretin amyloid cardiomyopathy (ATTR CM).
NNC6019-0001 is currently in Phase 3 clinical development. The Phase 3 trial, called CLEOPATTRA, is recruiting participants to study the drug's effects in people with heart failure due to transthyretin amyloidosis. Earlier Phase 2 trials have been completed or are ongoing.
NNC6019-0001 is being studied in three clinical trials. NCT05442047 is a completed Phase 2 trial with 105 participants. NCT06260709 is an active Phase 2 long-term extension study with 80 participants. NCT07207811 is the Phase 3 CLEOPATTRA trial, currently recruiting 1,280 participants.
Yes, NNC6019-0001 is also known as coramitug. The Phase 3 clinical trial CLEOPATTRA refers to the drug as coramitug (NNC6019-0001). Both names refer to the same investigational small molecule being developed for transthyretin amyloid cardiomyopathy (ATTR CM).