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NNC6019-0001 for Transthyretin Amyloid Cardiomyopathy
Phase 2
Waitlist Available
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
Estimated glomerular filtration rate (eGFR) >= 25 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) at screening
Presently classified as New York Heart Association (NYHA) Class II-III
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to visit 16 (week 64)
Awards & highlights
Study Summary
This trial is testing a new potential medicine, NNC6019-0001, for heart disease caused by TTR amyloidosis. The study will look at if this medicine can reduce symptoms of heart failure associated with the disease. Participants will be randomly assigned to receive either the new medicine or a placebo, and the study will last about 64 weeks.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since NNC6019-0001 is new and not yet approved for use outside trials, potential side effects aren't fully known but may include reactions at the infusion site or general symptoms like fatigue or nausea which are common with infusions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by eGFR, is adequate.
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My heart condition limits my physical activity but I can still perform light tasks.
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I walked between 150 and 450 meters in a 6-minute test.
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I have been diagnosed with Transthyretin amyloid cardiomyopathy.
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I am between 18 and 85 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week 0) to visit 16 (week 64)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to visit 16 (week 64)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 6-minute walk test (6-MWT)
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Secondary outcome measures
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
Change in global longitudinal strain (GLS) on echocardiography
Change in myocardial extracellular volume (ECV)
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: NNC6019-0001, 60 mg/kgExperimental Treatment1 Intervention
Participants will receive i.v. infusion of 60 mg/kg NNC6019-0001 Q4W added to standard of care until week 52.
Group II: NNC6019-0001, 10 mg/kgExperimental Treatment1 Intervention
Participants will receive intravenous (i.v.) infusion of 10 milligrams per kilograms (mg/kg) 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.
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Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,930 Total Patients Enrolled
1 Trials studying Transthyretin Amyloid Cardiomyopathy
120 Patients Enrolled for Transthyretin Amyloid Cardiomyopathy
Clinical Transparency 2834Study DirectorNovo Nordisk A/S
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.The thickness of a specific heart wall is greater than or equal to 12 millimeters.I haven't had a heart attack, stroke, or major surgery in the last 3 months.My kidney function, measured by eGFR, is adequate.My heart condition limits my physical activity but I can still perform light tasks.I walked between 150 and 450 meters in a 6-minute test.My heart condition is not mainly due to transthyretin amyloid cardiomyopathy.I have been diagnosed with Transthyretin amyloid cardiomyopathy.I am either male or female.You have had a previous organ transplant.Your N-terminal-pro brain natriuretic peptide (NT-proBNP) level is higher than 650 pg/mL in normal heart rhythm or more than 1000 pg/mL in irregular heart rhythm.I am scheduled for an organ transplant during the study.I have been on a steady dose of heart medication for at least 6 weeks.My weight is over 120 kg.I am between 18 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: NNC6019-0001, 10 mg/kg
- Group 2: NNC6019-0001, 60 mg/kg
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any elderly patients being included in the testing for this new medication?
"Eligibility requirements for this study include being between 18-85 years old."
Answered by AI
How many different sites are administering this trial?
"Right now, this trial is enrolling patients at 9 different hospitals. For example, there are sites in Rochester, Calgary and Beverly Hills. If you decide to enroll in the trial, try to choose a location that is close to minimize travel time and expenses."
Answered by AI
How do I sign up for the clinical study?
"Eligible patients for this study must have a diagnosis of transthyretin amyloid cardiomyopathy (attr cm). The age range for potential participants is 18 to 85 years old. So far, the clinical trial has recruited 99 people in total."
Answered by AI
Are any slots still available for volunteers in this experiment?
"Yes, this information is accurate. The trial's most recent update was on November 10th, 2022 and it is still recruiting patients."
Answered by AI
How many volunteers are needed for this clinical research?
"Yes, that is accurate. The information available on clinicaltrials.gov indicates that this study opened up recruitment on 8/2/2022 and is still looking for participants. 99 individuals are needed to complete the trial at 9 different locations."
Answered by AI
What is the NNC6019-0001's status in terms of federal approval?
"NNC6019-0001's safety was given a 2 because, while there is some evidence of its safety from Phase 2 trials, none of these trials showed any efficacy."
Answered by AI
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