Ensayos clínicos

Inclusion criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Completed study intervention in NN6019-4940a and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16.
• Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.

Exclusion criteria: 

Participants are excluded from the study if any of the following criteria apply:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Previous enrolment in this study.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method, as defined in Appendix 4 (Section 10.4).
• Use of another approved or non-approved investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (whichever is longer) before screening, except study intervention used in study NN6019-4940.
• Participation (i.e., signed informed consent) in any interventional clinical study from visit 16 (week 64) in NN6019-4940 until visit 1 (screening) in the current study NN6019-7565.
• Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
• A prior solid organ transplant.
• Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, insitu 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.
• Aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 2.5 × the upper limit of normal (ULN) or total bilirubin ≥ 2 × ULN at screening.
• Body weight > 120 kg (264.6 lb) at screening.
• International normalised ratio (INR)>1.5 (unless participant is on anticoagulant therapyb , in which case excluded if INR >3.5) c .

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/11/2024. Questions regarding updates should be directed to the study team contact.