Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NNC6019-0001
Coramitug · 4 trials · 2 indications
Measured as count of events.
Measured as events.
Measured in Meters
Measured in Percentage
Measured as ratio.
Measured as milliliter per minute per centimeter cube (mL/min/cm\^3).
Measured as 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. |
| Cohort 1 | EXPERIMENTAL | The cohort includes participants that will be evaluated for the cardiac uptake of 89Zr coramitug. |
| Cohort 2 | EXPERIMENTAL | The cohort includes participants to evaluate the sink effect (if observed in cohort 1) and also evaluate competitive binding between 89Zr-coramitug and different dose levels of coramitug. |
| 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. |
| Coramitug | DRUG | Coramitug will be administered intravenously |
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. ...
Coramitug is being developed for transthyretin amyloid cardiomyopathy (ATTR CM), a form of heart failure caused by transthyretin amyloid deposits in heart tissue. It is an investigational small molecule studied in adults with this condition. Clinical development includes a Phase 3 trial and earlier-phase studies in patients with ATTR amyloidosis affecting the heart.
Coramitug is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk sponsors the clinical program, including the Phase 3 CLEOPATTRA study and earlier-phase trials in transthyretin amyloid cardiomyopathy. The drug is also referred to in company materials by the code NNC6019-0001.
Coramitug is in Phase 3 development. The Phase 3 CLEOPATTRA trial is currently recruiting, and earlier Phase 1 and Phase 2 studies have also been conducted. Coramitug is investigational and has not been approved for commercial use; it remains in clinical development for transthyretin amyloid cardiomyopathy.
Coramitug has been studied in four clinical trials. The Phase 3 CLEOPATTRA study (NCT07207811) is recruiting about 1,280 participants across many countries. Other trials include a Phase 1 PET/CT imaging study (NCT07448623), an active Phase 2 long-term treatment study (NCT06260709), and a completed Phase 2 study (NCT05442047).
Yes. Coramitug and NNC6019-0001 refer to the same investigational medicine from Novo Nordisk. NNC6019-0001 is the company code used in earlier trial titles, while Coramitug is the name used in newer studies such as the Phase 3 CLEOPATTRA trial in transthyretin amyloid cardiomyopathy.
Across the four reported Coramitug trials, total planned enrollment is about 1,487 participants. The largest is the Phase 3 CLEOPATTRA trial with roughly 1,280 participants. The studies are randomized, double-blind, and placebo-controlled, and participants are selected based on biomarkers related to transthyretin amyloid cardiomyopathy.