A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
5610 patients around the world
Available in Puerto Rico, Argentina, United States, Mexico, Brazil
Novo Nordisk A/S
61Research sites
5610Patients around the world
This study is for people with
Obesity
Heart failure
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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.
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.
Sites
Instituto de Especialidades de la Salud Rosario Clínica del Tórax
España 931, Rosario, Santa Fe
Centro de Investigaciones Clínicas Baigorria
San Jorge 204, S2152BOF Granadero Baigorria, Santa Fe, Argentina
Centro Médico Saavedra
Av. Ruiz Huidobro 4693, C1430 Cdad. Autónoma de Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Viamonte 2213, C1056ABI Cdad. Autónoma de Buenos Aires, Argentina
Instituto de Investigaciones Clínicas (IIC) - Rosario
Paraguay 160, S2000CVD Rosario, Santa Fe, Argentina
Centro de Investigaciones Clínicas Instituto del Corazón - CICIC - Córdoba
Pedro de Oñate 253, Córdoba
Instituto de Investigaciones Clínicas San Nicolás
Pellegrini 346, San Nicolás
Centro Médico Maffei - CABA, Buenos Aires
Av. Cerviño 3375, CABA, Buenos Aires
Centro de Diagnóstico y Rehabilitación - CEDIR
SAN MARTIN 3169 – Santa Fe, Santa Fe. CP 3000
Centro de Investigaciones Clínicas del Litoral SRL