Pharmaceutical formulations
Disclosed herein are an aqueous pharmaceutical formulation comprising cagrilintide and an aqueous formulation comprising semaglutide. The compositions of these two pharmaceutical formulations allow for their presentation in, and administration using, the dual-chamber medical device disclosed herein. Individuals with diseases, such as diabetes and/or obesity and/or related co-morbidities, may benefit from the co-administration of semaglutide and cagrilintide, and/or of the two liquid pharmaceutical formulations disclosed herein, using the medical device disclosed herein.
1 . A method of treating obesity or overweight in a subject in need thereof, comprising administering a fixed-dose combination of 0.025-5.0 mg cagrilintide and 0.05-5.0 mg semaglutide subcutaneously in a single injection.
2 . The method of claim 1 , wherein said subject has an initial body mass index (BMI) of 30 kg/m2 or greater.
3 . The method of claim 1 , wherein said subject has an initial body mass index (BMI) of 27 kg/m2 or greater.
4 . The method of claim 1 , wherein said subject has at least one weight-related co-morbidity.
5 . The method of claim 4 , wherein the weight-related comorbidity is selected from the group consisting of hypertension, diabetes, dyslipidaemia, high cholesterol and obstructive sleep apnoea.
6 . The method of claim 4 , wherein the weight-related comorbidity is one or a combination of the diseases selected from the group consisting of diabetes, cardiovascular disease, non-alcoholic fatty liver disease (NAFLD), and non-alcoholic steatohepatitis (NASH).
7 . The method of claim 1 , wherein the ratio (in mg) of cagrilintide to semaglutide is about 1:1.
8 . The method of claim 1 , wherein the dose of cagrilintide administered is 0.25 mg, 0.5 mg, 1.0 mg, 1.2 mg, 1.7 mg, 2.4 mg or 4.5 mg.
9 . The method of claim 1 , wherein the dose of semaglutide administered is 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg.
10 . The method of claim 1 , wherein the dose of cagrilintide administered is 0.25 mg and the dose of semaglutide administered is 0.25 mg.
11 . The method of claim 1 , wherein the dose of cagrilintide administered is 0.5 mg and the dose of semaglutide administered is 0.5 mg.
12 . The method of claim 1 , wherein the dose of cagrilintide administered is 1.0 mg and the dose of semaglutide administered is 1.0 mg.
13 . The method of claim 1 , wherein the dose of cagrilintide administered is 1.7 mg and the dose of semaglutide administered is 1.7 mg.
14 . The method of claim 1 , wherein the dose of cagrilintide administered is 2.4 mg and the dose of semaglutide administered is 2.4 mg.
15 . The method of claim 1 , wherein the cagrilintide and semaglutide formulations are administered, in a single injection, approximately once weekly.
16 . The method of claim 15 , wherein the ratio (in mg) of cagrilintide to semaglutide is about 1:1 and wherein the dose of cagrilintide administered is 0.25 mg, 0.5 mg, 1.0 mg, 1.2 mg, 1.7 mg, or 2.4 mg and the dose of semaglutide administered is 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg.
17 . A method of treating obesity or overweight in a subject in need thereof, comprising administering subcutaneously in a single injection
0.25 mg cagrilintide and 0.25 mg semaglutide once a week for four weeks (weeks 0-3);
0.5 mg cagrilintide and 0.5 semaglutide once a week for four weeks (weeks 4-7);
1.0 mg cagrilintide and 1.0 semaglutide once a week for four weeks (weeks 8-11);
1.7 mg cagrilintide and 1.7 mg semaglutide once a week for four weeks (weeks 12-15); and
2.4 mg cagrilintide and 2.4 mg semaglutide mg once a week thereafter.
18 . The method of claim 17 , wherein said subject has an initial body mass index (BMI) of 30 kg/m2 or greater.
19 . The method of claim 17 , wherein said subject has an initial body mass index (BMI) of 27 kg/m2 or greater.
20 . The method of claim 17 , wherein said subject has at least one weight-related co-morbidity.
21 . The method of claim 20 , wherein the weight-related comorbidity is selected from the group consisting of hypertension, diabetes, dyslipidaemia, high cholesterol and obstructive sleep apnoea.
22 . The method of claim 20 , wherein the weight-related comorbidity is one or a combination of the diseases selected from the group consisting of diabetes, cardiovascular disease, non-alcoholic fatty liver disease (NAFLD), and non-alcoholic steatohepatitis (NASH).
23 . A method of treating diabetes or delaying diabetes progression, or delaying or reducing the development of a major adverse cardiovascular event (MACE), or treating non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) in a subject in need thereof, comprising administering a fixed-dose combination of 0.025-5.0 mg cagrilintide and 0.05-5.0 mg semaglutide subcutaneously in a single injection.
24 . The method of claim 23 , wherein diabetes is type 2 diabetes.
25 . The metho of claim 23 , wherein MACE is selected from the group consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularisation, hospitalization for unstable angina pectoris, and hospitalization for heart failure.