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NNC6019-0001 for Transthyretin Amyloid Cardiomyopathy

Phase 2
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). Dihydropyridine calcium channel blockers are allowed. Digoxin allowed only for management of atrial fibrillation with rapid ventricular response
Body weight greater than 120 kilograms (kg) at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) up to visit 39 (week 156)
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a medicine, NNC6019-0001, for people with heart disease caused by TTR amyloidosis. It will assess the long-term safety and effectiveness of the medicine

Who is the study for?
This trial is for people who have heart failure due to Transthyretin Amyloidosis and were part of a previous study on the medicine NNC6019-0001. Only those who completed the initial study can join this long-term research to further assess safety and effectiveness.
What is being tested?
The trial is testing NNC6019-0001, focusing on its long-term safety and ability to alleviate symptoms of heart disease caused by TTR amyloidosis. Participants will receive NNC6019-0001 for up to 157 weeks, regardless of their prior treatment group.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions over the course of three years as they continue treatment with NNC6019-0001.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking specific heart medications, but not those that mainly affect blood pressure.
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My body weight is over 120 kg.
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I have had a solid organ transplant in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) up to visit 39 (week 156)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) up to visit 39 (week 156) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Treatment Emergent Adverse Events
Secondary study objectives
Change in 6-Minute Walk Test (6MWT)
Change in Global Longitudinal Strain (GLS) on Echocardiography
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NNC6019-0001Experimental Treatment1 Intervention
Participants will receive NNC6019-0001 intravenously every 4 weeks added to the standard of care until Week 140.

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,552 Previous Clinical Trials
2,444,955 Total Patients Enrolled
1 Trials studying Transthyretin Amyloid Cardiomyopathy
120 Patients Enrolled for Transthyretin Amyloid Cardiomyopathy
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
133 Previous Clinical Trials
153,262 Total Patients Enrolled
~53 spots leftby Feb 2028
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