NIPH Clinical Trials Search

HF-POLARIS: A research study to look at how well NNC0487-0111 works compared to placebo in people with heart failure and obesity

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Heart failure
Date of first enrollment	11/05/2026
Target sample size	113
Countries of recruitment	Argentina,Japan,Australia,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,India,Japan,Israel,Japan,Italy,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,China Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	Drug: NNC0487-0111 NNC0487-011 will be administered subcutaneously. Drug: Placebo Placebo will be administered subcutaneously.

Outcome(s)

Primary Outcome	Time to first occurrence of a composite HF endpoint consisting of: -CV death -HF hospitalisationa or urgent HF visit
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Body Mass Index (BMI) greater than or equal to (>=) 30 kilograms per square metre (kg/m^2) at screening. - Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator. For participants with Type 2 Diabetes (T2D) at screening: - Diagnosed with T2D >= 30 days before screening.
Exclude criteria	'- MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization. - HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree. - Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as: requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening. - Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism). Glycaemia-related: - History of type 1 diabetes. - Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. - Glycated haemoglobin (HbA1c) greater than (>) 10 percent (%) (86 [millimoles per mole] mmol/mol) as measured by local or central laboratory at screening.