Efficacy and safety of NNC6019-0001 at two dose levels in participants with transthyretin amyloid cardiomyopathy (ATTR CM)
- Conditions
- cardiomyopathy10019280
- Registration Number
- NL-OMON51443
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 9
• Male or female.
• Age >= 18 to < 85 years at the time of signing informed consent.
• Have an established diagnosis of ATTR CM with either wild-type TTR or
hereditary TTR
genotype as per local standards.
• Expected to be on stable doses of cardiovascular medical therapy 6 weeks
prior to the
randomisation visit.
• Known end-diastolic interventricular septal wall thickness >= 12 mm.
• Presently classified as New York Heart Association (NYHA) Class II-III.
• NT-proBNP concentration >=650 pg/mL in sinus cardiac rhythm and >1000 pg/mL in
atrial fibrillation
at screening.
• Completed >=150 meters to <=450 meters on the 6-MWT at screening.
• Estimated glomerular filtration rate (eGFR) >=25 mL/min/1.73 m2 at screening.
• Cardiomyopathy not primarily caused by ATTR CM, for example, cardiomyopathy
due to hypertension, valvular heart disease, or ischemic heart disease
• A prior solid organ transplant
• Planned solid organ transplant during the study
• Presence or history of malignant neoplasm (other than basal or squamous cell
skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic
intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years
before screening
• Current treatment with calcium channel blockers with conduction system
effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium
channel blockers is allowed. The use of digoxin will only be allowed if
required for management of atrial fibrillation with rapid ventricular response
• Acute coronary syndrome, unstable angina, stroke, transient ischemic attack
(TIA), coronary revascularization, cardiac valve repair, or major surgery
within 3 months of screening
• Body weight >120 kg (264.6 lb) at screening
• History of contrast allergy or adverse reactions to gadolinium-containing
agents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in 6-minute walktest (6-MWT) From baseline (week 0) to visit 15 (week<br /><br>52) - Meters<br /><br><br /><br>Change in NT-proBNP From baseline (week 0) to visit 15 (week 52) - Percentage</p><br>
- Secondary Outcome Measures
Name Time Method