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.

Research Team

Clinical Transparency 2834

Principal Investigator

Novo Nordisk A/S

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 Japan for the following indications: