Therapeutic Regimens and Methods for Lowering Blood Glucose and/or Body Weight using GLP-1R and GCGR Balanced Agonists
This disclosure relates to the once weekly dosing regimen of a dual GLP-1R and GCGR agonist, formulations, and methods of using the same for treatment of chronic weight management, obesity and/or blood glucose control, including but not limited to dual agonist peptide product of SEQ ID NO. 1.
1 - 39 . (canceled)
40 . A method to reduce excess body weight and maintain weight reduction in treatment of chronic weight management in a human being in need thereof comprising administering to the human being a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1.
41 . The method of claim 40 , wherein the treatment reduces liver fat.
42 . The method of claim 40 , wherein the treatment lowers blood glucose.
43 . The method of claim 40 , wherein the pharmaceutical dosage formulation is administered subcutaneously.
44 . The method of claim 40 , wherein the treatment is an adjunct treatment with a reduced calorie diet and/or exercise.
45 . The method of claim 40 , wherein the pharmaceutical dosage is an aqueous formulation comprising one or more of polysorbate 20, arginine, or mannitol.
46 . The method of claim 40 , wherein the pharmaceutical dosage formulation comprises polysorbate 20, about 0.2-0.5% (w/w) arginine, and about 3-6% (w/w) mannitol in water (pH 7.7±0.1).
47 . The method of claim 40 , wherein the pharmaceutical dosage formulation comprises polysorbate 20, about 0.348% (w/w) arginine, about 4.260% (w/w) mannitol in water (pH 7.7±0.1).
48 . The method of claim 40 , wherein the human being in need thereof has a body mass index (BMI kg/m 2 ) of at least 25.
49 . The method of claim 40 , wherein the human being in need thereof has a body mass index (BMI kg/m 2 ) of at least 30.
50 . The method of claim 40 , wherein the human being in need thereof has a body mass index (BMI kg/m 2 ) of at least 35.
51 . The method of claim 40 , wherein the human being in need thereof has a body mass index (BMI kg/m 2 ) of at least 40.
52 . The method of claim 40 , wherein the human being in need thereof has a co-morbidity selected from one or more of type 2 diabetes, polycystic ovary syndrome (PCOS), hyperglycemia, and hyperinsulinemia.
53 . The method of claim 40 , wherein the pharmaceutical dosage formulation is administered weekly for at least 12 weeks.
54 . A method to reduce excess body weight and maintain weight reduction in treatment of chronic weight management in a human being in need thereof comprising administering to the human being a once weekly therapeutic effective amount of a pharmaceutical dosage formulation comprising SEQ ID NO: 1 polysorbate 20, about 0.348% (w/w) arginine, about 4.260% (w/w) mannitol in water (pH 7.7±0.1).
55 . The method of claim 54 , wherein the treatment reduces liver fat.
56 . The method of claim 54 , wherein the treatment lowers blood glucose.
57 . The method of claim 54 , wherein the pharmaceutical dosage formulation is administered subcutaneously.
58 . The method of claim 54 , wherein the treatment is an adjunct treatment with a reduced calorie diet and/or exercise.
59 . The method of claim 54 , wherein the human being in need thereof has a co-morbidity selected from one or more of type 2 diabetes, polycystic ovary syndrome (PCOS), hyperglycemia, and hyperinsulinemia.