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A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity
1408 patients around the world
Available in Argentina, Brazil, Puerto Rico, United States
Novo Nordisk A/S
10Research sites
1408Patients around the world
This study is for people with
Arterial hypertension
Obesity
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Male or female (sex at birth).Age 18 years or above at the time of signing the informed consent.Resting in-office SBP of 140-160 mmHg (both inclusive) at screening (V1-Optional/V1) and the Run-in visit. Systolic blood pressure will be calculated as the mean of the second and third consecutive readings of triplicated blood pressure readings collected at 2-minute intervals with the blood pressure monitor provided by the Sponsor.Body mass index greater than or equal to (>=) 30.0 kilograms per metre square (kg/m^2) at screening.Not receiving Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) or antihypertensive medication or on stable (i.e., same drug(s), dose and dosing frequency) SGLT2i or antihypertensive treatment >= 30 days prior to screening.For participants with Type 2 Diabetes (T2D).The following inclusion criteria apply at screening in addition to the inclusion criteria listed above.Diagnosed with T2D >= 90 days before screening.Glycated Haemoglobin (HbA1c) 6.5-10.0% (48-86 millimoles per mole (mmol/mol)) (both inclusive) as measured by the central laboratory at screening.Treatment with either lifestyle intervention only, or treatment with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors, glinides, SGLT2i or thiazolidinediones, as a single agent or in combination) according to local label.Treatment with antidiabetic medication should be stable (i.e., same drug(s), dose and dosing frequency) for at least 90 days before screening.
- Known orthostatic hypotension or orthostatic hypotension at screening (V1-Optional/V1).Known secondary hypertension due to renovascular hypertension (renal artery stenosis), primary aldosteronism, Cushing's syndrome, pheochromocytoma, acromegaly, coarctation of the aorta, or any other identifiable cause of secondary hypertension.Currently under medical investigation for any cause of secondary hypertension.Hospitalisation within the last 90 days before screening for hypertension or hypertensive crisis.Atrial fibrillation at the Run-in visit or history of frequent intermittent or chronic atrial fibrillation.Moderate-to-severe anaemia with Hgb lesser than (<) 10.9 grams per decilitre (g/dL) as measured by the central lab at screening.A change in body weight greater than (>) 5% within 90 days before screening irrespective of medical records.Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.Use of any Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin agonists, within 90 days before screening.For participants without T2D.HbA1c greater than or equal to >= 6.5 % (48 mmol/mol) as measured by the central laboratory at screening.History of type 1 or type 2 diabetes mellitus.
Sites
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Centro Médico Viamonte SRL - CABA, Buenos Aires
Centro Médico Maffei - CABA, Buenos Aires
Sanatorio Norte SRL - Santiago del Estero
Mautalen - Salud e Investigación - CABA
Centro Especialidades Médicas SRL (CEMEDIC)
Fundación Centro de Salud e Investigaciones Médicas (CESIM)
Hospital Español de Mendoza
CEDIC Centro de Investigación Clínica - CABA, Buenos Aires
Instituto CAICI - Rosario, Santa Fe
StudyREDEFINE
SponsorNovo Nordisk A/S
Study typeInterventional
Conditions
Arterial hypertensionObesity
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07919405
