NZ772004B2 - Methods of using a gip/glp1 co-agonist for therapy - Google Patents
Methods of using a gip/glp1 co-agonist for therapyInfo
- Publication number
- NZ772004B2 NZ772004B2 NZ772004A NZ77200419A NZ772004B2 NZ 772004 B2 NZ772004 B2 NZ 772004B2 NZ 772004 A NZ772004 A NZ 772004A NZ 77200419 A NZ77200419 A NZ 77200419A NZ 772004 B2 NZ772004 B2 NZ 772004B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- dose
- escalation
- tirzepatide
- acceptable salt
- pharmaceutically acceptable
- Prior art date
Links
Abstract
The present invention provides a method for increasing glycemic control in a patient in need thereof, by administering tirzepatide, or a pharmaceutically acceptable salt thereof. The present invention provides a method for improving weight management in a patient in need thereof, by administering tirzepatide, or a pharmaceutically acceptable salt thereof. Further providing a method for treating a condition selected from atherosclerosis, chronic kidney disease, NAFLD, and NASH. Further provided is a method to prevent or induce remission of diabetes comprising administration of tirzepatide, or a pharmaceutically acceptable salt thereof. Further provided is a dosing regimen for increasing glycemic control, improving weight management, and/or treating dyslipidemia.
Claims (44)
1. Use of tirzepatide, or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for treating type 2 diabetes in a patient in need thereof, wherein the treating comprises administering the medicament to the patient so as to 5 provide a once weekly escalation dose of 2.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof, for four weeks and thereafter administering a once weekly maintenance dose of 5, 10, or 15 mg of tirzepatide, or a pharmaceutically acceptable salt thereof, for at least four weeks.
2. Use of tirzepatide, or a pharmaceutically acceptable salt thereof, in the 10 manufacture of a medicament for treating type 2 diabetes in a patient in need thereof, wherein the treating comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of four weeks and at least one maintenance dose once weekly for a minimum of four weeks following the escalation dose; wherein the escalation dose is selected from the group consisting of 2.5 15 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose following an escalation dose is a 2.5 mg increment.
3. The use according to claim 1 or 2, wherein the maintenance dose is 15 mg. 20
4. The use according to claim 1 or 2, wherein the maintenance dose is 10 mg.
5. The use according to claim 1 or 2, wherein the escalation dose is 2.5 mg and the maintenance dose is 5.0 mg.
6. The use according to claim 2, wherein the escalation dose is 7.5 mg and the maintenance dose is 10.0 mg. 25
7. The use according to claim 2, wherein the escalation dose is 12.5 mg and the maintenance dose is 15.0 mg.
8. The use according to claim 1 or 2, which lowers HbA1c with reduced adverse gastrointestinal events.
9. Use of tirzepatide, or a pharmaceutically acceptable salt thereof, in the 30 manufacture of a medicament for inducing remission or regression of diabetes in a patient in need thereof, wherein the inducing comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of at least two weeks and thereafter at least one maintenance dose once weekly for a minimum of at least two weeks; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg 5 and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof.
10. The use according to claim 9, wherein the inducing comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of four weeks and at least one maintenance dose once weekly for a minimum of four weeks following the escalation dose; wherein the escalation dose is selected from the 10 group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose following an escalation dose is a 2.5 mg increment. 15
11. The use according to claim 9 or 10, wherein the escalation dose is 2.5 mg and the maintenance dose is 5.0 mg.
12. The use according to claim 9 or 10, wherein the escalation dose is 7.5 mg and the maintenance dose is 10.0 mg.
13. The use according to claim 9 or 10, wherein the escalation dose is 12.5 mg and the 20 maintenance dose is 15.0 mg.
14. Use of tirzepatide, or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for preventing diabetes in a patient in need thereof, wherein the preventing comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of at least two weeks and thereafter 25 at least one maintenance dose once weekly for a minimum of at least two weeks; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof. 30
15. The use according to claim 14, wherein the preventing comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of four weeks and at least one maintenance dose once weekly for a minimum of four weeks following the escalation dose; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically 5 acceptable salt thereof; and wherein the maintenance dose following an escalation dose is a 2.5 mg increment.
16. The use according to claim 14 or 15, wherein the escalation dose is 2.5 mg and the maintenance dose is 5.0 mg.
17. The use according to claim 14 or 15, wherein the escalation dose is 7.5 mg and the 10 maintenance dose is 10.0 mg.
18. The use according to claim 14 or 15, wherein the escalation dose is 12.5 mg and the maintenance dose is 15.0 mg.
19. Use of tirzepatide, or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for improving weight management in a patient in need 15 thereof, wherein the improving comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of at least two weeks and thereafter at least one maintenance dose once weekly for a minimum of at least two weeks; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and 20 wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof.
20. The use according to claim 19, wherein the improving comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of four weeks and at least one maintenance dose once weekly for a 25 minimum of four weeks following the escalation dose; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose following an escalation dose is 30 a 2.5 mg increment.
21. The use according to claim 19 or 20, wherein the escalation dose is 2.5 mg and the maintenance dose is 5.0 mg.
22. The use according to claim 19 or 20, wherein the escalation dose is 7.5 mg and the maintenance dose is 10.0 mg.
23. The use according to claim 19 or 20, wherein the escalation dose is 12.5 mg and the maintenance dose is 15.0 mg. 5
24. Use of tirzepatide, or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for treating chronic kidney disease in a patient in need thereof, wherein the treating comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of at least two weeks and thereafter at least one maintenance dose once weekly for a minimum of at least two 10 weeks; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof.
25. The use according to claim 24, wherein the treating comprises administering the 15 medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of four weeks and at least one maintenance dose once weekly for a minimum of four weeks following the escalation dose; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; wherein the maintenance dose is selected from the group 20 consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose following an escalation dose is a 2.5 mg increment.
26. The use according to claim 24 or 25, wherein the escalation dose is 2.5 mg and the maintenance dose is 5.0 mg. 25
27. The use according to claim 24 or 25, wherein the escalation dose is 7.5 mg and the maintenance dose is 10.0 mg.
28. The use according to claim 24 or 25, wherein the escalation dose is 12.5 mg and the maintenance dose is 15.0 mg.
29. Use of tirzepatide, or a pharmaceutically acceptable salt thereof, in the 30 manufacture of a medicament for treating nonalcohol fatty liver disease in a patient in need thereof, wherein the treating comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of at least two weeks and thereafter at least one maintenance dose once weekly for a minimum of at least two weeks; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg 5 and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof.
30. The use according to claim 29, wherein the treating comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of four weeks and at least one maintenance dose once weekly for a minimum of four weeks following the escalation dose; wherein the escalation dose is selected from the 10 group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose following an escalation dose is a 2.5 mg increment. 15
31. The use according to claim 29 or 30, wherein the escalation dose is 2.5 mg and the maintenance dose is 5.0 mg.
32. The use according to claim 29 or 30, wherein the escalation dose is 7.5 mg and the maintenance dose is 10.0 mg.
33. The use according to claim 29 or 30, wherein the escalation dose is 12.5 mg and 20 the maintenance dose is 15.0 mg.
34. Use of tirzepatide, or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for treating nonalcohol steatohepatitis in a patient in need thereof, wherein the treating comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of at least two weeks 25 and thereafter at least one maintenance dose once weekly for a minimum of at least two weeks; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof. 30
35. The use according to claim 34, wherein the treating comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of four weeks and at least one maintenance dose once weekly for a minimum of four weeks following the escalation dose; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically 5 acceptable salt thereof; and wherein the maintenance dose following an escalation dose is a 2.5 mg increment.
36. The use according to claim 34 or 35, wherein the escalation dose is 2.5 mg and the maintenance dose is 5.0 mg.
37. The use according to claim 34 or 35, wherein the escalation dose is 7.5 mg and the 10 maintenance dose is 10.0 mg.
38. The use according to claim 34 or 35, wherein the escalation dose is 12.5 mg and the maintenance dose is 15.0 mg.
39. Use of tirzepatide, or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for treating diabetic kidney disease in a patient in need 15 thereof, wherein the treating comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of at least two weeks and thereafter at least one maintenance dose once weekly for a minimum of at least two weeks; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein 20 the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof.
40. The use according to claim 39, wherein the treating comprises administering the medicament to the patient so as to provide at least one escalation dose once weekly for a minimum of four weeks and at least one maintenance dose once weekly for a minimum of 25 four weeks following the escalation dose; wherein the escalation dose is selected from the group consisting of 2.5 mg, 7.5 mg and 12.5 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; wherein the maintenance dose is selected from the group consisting of 5.0 mg, 10.0 mg and 15.0 mg of tirzepatide, or a pharmaceutically acceptable salt thereof; and wherein the maintenance dose following an escalation dose is 30 a 2.5 mg increment.
41. The use according to claim 39 or 40, wherein the escalation dose is 2.5 mg and the maintenance dose is 5.0 mg.
42. The use according to claim 39 or 40, wherein the escalation dose is 7.5 mg and the maintenance dose is 10.0 mg.
43. The use according to claim 39 or 40, wherein the escalation dose is 12.5 mg and the maintenance dose is 15.0 mg. 5
44. Use according to any one of claims 1 to 43, substantially as herein described with reference to any example thereof.
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ772004A NZ772004A (en) | 2025-01-31 |
| NZ772004B2 true NZ772004B2 (en) | 2025-05-01 |
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