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Publication Number
US-12569543-B2
Publication Date
2026-03-10
Expiration Date
Abstract
The present invention relates to the GLP-1 receptor agonist semaglutide for use in medicine.
Core Innovation
Semaglutide is disclosed for chronic treatment of adults with type 2 diabetes and high cardiovascular risk, including clinical and/or subclinical cardiovascular disease evidence. The disclosed methods aim to delay and/or reduce major adverse cardiovascular events (MACE), including cardiovascular (CV) death, non-fatal myocardial infarction (MI), and non-fatal stroke.
The methods administer semaglutide as a pharmaceutical composition containing semaglutide, with semaglutide administered in an amount of 0.05-2.0 mg once weekly by subcutaneous injection. The subject eligibility is based on having type 2 diabetes and cardiovascular disease, where cardiovascular disease may be selected from specified clinical and/or subclinical evidence criteria.
Documented patient-selection criteria include prior myocardial infarction, prior stroke or transient ischaemic attack, prior coronary, carotid, or peripheral arterial revascularization, >50% stenosis on angiography or imaging, 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. The disclosure also describes semaglutide formulation characteristics for a pharmaceutical composition with a composition pH between 7.0 and 9.0, including aqueous solutions with specified excipients and pH.
An example formulation is described containing semaglutide at 1.34 mg/mL, disodium phosphate dihydrate at 1.42 mg/mL, propylene glycol at 14.0 mg/mL, and phenol at 5.5 mg/mL at pH about 7.4. The disclosure includes clinical trial outcomes versus placebo, including a reported hazard ratio for first MACE of about 0.74 with reported confidence intervals, and subgroup analyses including effects associated with BMI ≤30 and heart failure NYHA class I/no HF.
Claims Coverage
The partial content provides two independent claims, both directed to methods of reducing the risk of MACE in a subject in need thereof using semaglutide administered once weekly by subcutaneous injection at 0.05-2.0 mg. Across both independent claims, the inventive framework centers on identifying an at-risk subject with type 2 diabetes and cardiovascular disease and selecting MACE components from CV death, non-fatal MI, and non-fatal stroke.
Once-weekly semaglutide by subcutaneous injection to reduce MACE risk in type 2 diabetes with cardiovascular disease
A method of reducing the risk of a major adverse cardiovascular event (MACE) in a subject in need thereof, comprising 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.
Selecting cardiovascular disease evidence for MACE risk reduction using semaglutide once weekly subcutaneous dosing
A method of reducing the risk of a major adverse cardiovascular event (MACE) in a subject in need thereof, comprising 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.
Both independent claims require administering semaglutide 0.05-2.0 mg once weekly by subcutaneous injection to subjects with type 2 diabetes and cardiovascular disease to reduce risk of MACE selected from CV death, non-fatal MI, and non-fatal stroke. The claims coverage further supports narrowing through specified clinical/subclinical cardiovascular disease evidence and defined semaglutide pharmaceutical composition parameters including component concentrations and pH.
Stated Advantages
Reduces the risk of major adverse cardiovascular events (MACE) including cardiovascular (CV) death, non-fatal myocardial infarction (MI), and non-fatal stroke.
Provides documented trial outcomes versus placebo, including a reported reduction for first MACE and component events such as non-fatal MI and non-fatal stroke.
Documented Applications
Chronic treatment of adults with type 2 diabetes and high cardiovascular risk to delay and/or reduce MACE (including CV death, non-fatal MI, and non-fatal stroke), with related broader MACE components including revascularisation and hospitalisations such as hospitalisation for UAP and hospitalisation for heart failure.
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