Claims for Patent: 12,569,543

Summary for Patent: 12,569,543

Title:	Semaglutide in cardiovascular conditions
Abstract:	The present invention relates to the GLP-1 receptor agonist semaglutide for use in medicine.
Inventor(s):	Oluf Kristian Hoejbjerg
Assignee:	Novo Nordisk AS
Application Number:	US16/097,032
Patent Claims:	1. A method of reducing the risk of a major adverse cardiovascular event (MACE) in a subject in need thereof, wherein the method comprises administering to the subject a pharmaceutical composition comprising semaglutide in an amount of 0.05-2.0 mg once weekly by subcutaneous injection; wherein the subject has type 2 diabetes and cardiovascular disease; and wherein the MACE is selected from the group consisting of cardiovascular (CV) death, non-fatal myocardial infarction (MI), and non-fatal stroke. 2. The method according to claim 1, wherein the cardiovascular disease is selected from the group consisting of clinical evidence of cardiovascular disease and subclinical evidence of cardiovascular disease; wherein the clinical evidence of cardiovascular disease is selected from the group consisting of prior myocardial infarction, prior stroke or transient ischaemic attack; prior coronary, carotid, or peripheral arterial revascularization; >50% stenosis on angiography or imaging of coronary, carotid, or lower extremity arteries; history of symptomatic coronary heart disease; asymptomatic cardiac ischemia; heart failure; and chronic renal impairment by estimated glomerular filtration rate<60 mL/min/1.73 m2 per modification of diet in renal disease (MDRD); and wherein the subclinical evidence of cardiovascular disease is selected from the group consisting of persistent microalbuminuria or proteinuria; hypertension and left ventricular hypertrophy by electrocardiogram (ECG) or imaging; left ventricular systolic or diastolic dysfunction; and ankle/brachial index<0.9. 3. The method according to claim 1, wherein the subject has a body mass index (BMI) of no more than 30 kg/m2. 4. The method according to claim 1, wherein the semaglutide is administered for at least 30 months. 5. The method according to claim 1, wherein the semaglutide is administered in a pharmaceutical composition comprising about 0.1-20 mg/ml semaglutide, about 2-15 mM phosphate buffer, about 2-25 mg/ml propylene glycol, about 1-18 mg/ml phenol, and has a pH in the range of 7.0-9.0. 6. The method according to claim 5, wherein the semaglutide is administered in a pharmaceutical composition comprising about 1.34 mg/ml semaglutide, about 1.42 mg/ml disodium phosphate dihydrate, about 14.0 mg/ml propylene glycol, about 5.5 mg/ml phenol, and has pH of about 7.4. 7. The method according to claim 6, wherein the semaglutide is administrated in a pharmaceutical composition comprising 1.34 mg/ml semaglutide, 1.42 mg/ml disodium phosphate dihydrate, 14.0 mg/ml propylene glycol, 5.5 mg/ml phenol, and has a pH of 7.4. 8. A method of reducing the risk of a major adverse cardiovascular event (MACE) in a subject in need thereof, wherein the method comprises administering to the subject a pharmaceutical composition comprising semaglutide in an amount of 0.05-2.0 mg once weekly by subcutaneous injection; wherein the subject has type 2 diabetes and cardiovascular disease; wherein the MACE is selected from the group consisting of CV death, non-fatal MI, and non-fatal stroke; and wherein the cardiovascular disease is selected from the group consisting of prior myocardial infarction; prior stroke or transient ischaemic attack; prior coronary, carotid, or peripheral arterial revascularization; >50% stenosis on angiography or imaging of coronary, carotid, or lower extremity arteries; history of symptomatic coronary heart disease; asymptomatic cardiac ischemia; heart failure; and chronic renal impairment by estimated glomerular filtration rate<60 mL/min/1.73 m2 per MDRD. 9. The method according to claim 8, wherein the subject has a BMI of no more than 30 kg/m2. 10. The method according to claim 8, wherein the semaglutide is administered for at least 30 months. 11. The method according to claim 8, wherein the semaglutide is administered in a pharmaceutical composition comprising about 0.1-20 mg/ml semaglutide, about 2-15 mM phosphate buffer, about 2-25 mg/ml propylene glycol, about 1-18 mg/ml phenol, and has a pH in the range of 7.0-9.0. 12. The method according to claim 11, wherein the semaglutide is administered in a pharmaceutical composition comprising about 1.34 mg/ml semaglutide, about 1.42 mg/ml disodium phosphate dihydrate, about 14.0 mg/ml propylene glycol, about 5.5 mg/ml phenol, and has pH of about 7.4. 13. The method according to claim 12, wherein the semaglutide is administrated in a pharmaceutical composition comprising 1.34 mg/ml semaglutide, 1.42 mg/ml disodium phosphate dihydrate, 14.0 mg/ml propylene glycol, 5.5 mg/ml phenol, and has a pH of 7.4.