NNC6019-0001 for Transthyretin Amyloid Cardiomyopathy
Recruiting in Palo Alto (17 mi)
+64 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Novo Nordisk A/S
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a new medicine, NNC6019-0001, for people with heart disease due to TTR amyloidosis. Participants will receive the medicine by chance, with a higher likelihood of getting the medicine. The goal is to see if it can reduce heart disease symptoms over a period of time.
Eligibility Criteria
This trial is for adults aged 18-85 with heart disease due to TTR amyloidosis, classified as NYHA Class II-III. They must have a specific diagnosis of ATTR CM, be on stable heart medication for 6 weeks prior, and meet certain lab test criteria. Exclusions include recent major cardiovascular events or surgeries, planned organ transplants, other types of cardiomyopathy, cancer history within 5 years, contrast allergies, and weight over 120 kg.Inclusion Criteria
The thickness of a specific heart wall is greater than or equal to 12 millimeters.
My kidney function, measured by eGFR, is adequate.
My heart condition limits my physical activity but I can still perform light tasks.
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Exclusion Criteria
You have had a bad reaction to a contrast dye or gadolinium in the past.
I am taking specific heart medications, but not those that majorly affect heart rhythm.
I have had cancer or was diagnosed with cancer in the last 5 years.
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Treatment Details
Interventions
- NNC6019-0001 (Unknown)
- Placebo (NNC6019-0001) (Unknown)
Trial OverviewThe study tests NNC6019-0001's effectiveness in reducing symptoms of heart disease caused by TTR amyloidosis compared to a placebo. Participants are randomly assigned treatment: the chance of receiving NNC6019-0001 is twice that of getting the placebo. The drug is administered via infusion every four weeks for approximately 64 weeks.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: NNC6019-0001, Dose 2Experimental Treatment1 Intervention
Participants will receive dose 2 i.v. infusion of NNC6019-0001 Q4W added to standard of care until week 52.
Group II: NNC6019-0001, Dose 1Experimental Treatment1 Intervention
Participants will receive dose 1 intravenous (i.v.) infusion of NNC6019-0001 every 4 weeks (Q4W) added to standard of care until week 52.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive i.v. infusion of placebo (NNC6019-0001) Q4W added to standard of care until week 52.
NNC6019-0001 is already approved in European Union, United States, Japan for the following indications:
🇪🇺 Approved in European Union as Coramitug for:
- Transthyretin amyloid cardiomyopathy (ATTR-CM)
🇺🇸 Approved in United States as Coramitug for:
- Transthyretin amyloid cardiomyopathy (ATTR-CM)
🇯🇵 Approved in Japan as Coramitug for:
- Transthyretin amyloid cardiomyopathy (ATTR-CM)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ctr for Cardiovascular InnovationVancouver, Canada
Mayo Clinic ArizonaPhoenix, AZ
Stanford Hlth Cre-Boswell ClinStanford, CA
University of Calgary_CardiologyCalgary, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Novo Nordisk A/SLead Sponsor