Therapeutic uses of dulaglutide

Patent metadata

Field	Value
Publication number	US-2024197835-A1
Application number	US-202318523645-A
Country	US
Kind code	A1
Filing date	Nov 29, 2023
Priority date	Jun 1, 2017
Publication date	Jun 20, 2024
Grant date	—

Abstract

The present invention relates to methods of using dulaglutide for the treatment of chronic kidney disease in patients having moderate to late stage chronic kidney disease.

First claim

1 - 41 . (canceled)

42 . A method of treating a subject having type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), comprising: administering to the subject 1.5 mg of dulaglutide once a week for a duration sufficient to provide improved glycemic control, an attenuated rate of estimated glomerular filtration rate (eGFR) decline, and a reduced urine albumin to urine creatinine ratio (UACR); wherein prior to initiating the administration the subject's CKD is characterized by an eGFR of 15-29 mL/min/1.73 m 2 and a UACR greater than 300 mg/g.

43 . The method of claim 42 wherein the decreased rate of loss of eGFR is not entirely dependent on improvements to the patient's glycemic control.

44 . The method of claim 42 wherein the patient's CKD is not caused by T2DM.

45 . The method of claim 42 wherein the patient's CKD is caused by T2DM.

46 . The method of claim 42 , further comprising administering an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin receptor blocker (ARB).

47 . The method of claim 42 , wherein the duration is at least 26 weeks.

48 . The method of claim 42 , wherein the duration is at least 52 weeks.

49 . The method of claim 47 , wherein the improved glycemic control at 26 weeks is characterized by a percent HbA1c reduction of at least 1%.

50 . The method of claim 48 , wherein the improved glycemic control at 52 weeks is characterized by a percent HbA1c reduction of at least 1%.

51 . The method of claim 47 , wherein the attenuated rate of eGFR decline at 26 weeks is characterized by a reduction in eGFR of not more than 3.5 mL/min/1.73 m 2 over 26 weeks.

52 . The method of claim 47 , wherein the attenuated rate of eGFR decline at 26 weeks is characterized by a reduction in eGFR of not more than 1.9 mL/min/1.73 m 2 over 26 weeks.

53 . The method of claim 48 , wherein the attenuated rate of eGFR decline at 52 weeks is characterized by a reduction in eGFR of not more than 5.4 mL/min/1.73 m 2 over 52 weeks.

54 . The method of claim 48 , wherein the attenuated rate of eGFR decline at 52 weeks is characterized by a reduction in eGFR of not more than 3.4 mL/min/1.73 m 2 over 52 weeks.

55 . The method of claim 47 , wherein the reduced UACR at 26 weeks is characterized by a UACR reduction of at least 28%.

56 . The method of claim 47 , wherein the reduced UACR at 26 weeks is characterized by a UACR reduction of at least 43%.

57 . The method of claim 48 , wherein the reduced UACR at 52 weeks is characterized by a UACR reduction of at least 11%.

58 . The method of claim 48 , wherein the reduced UACR at 52 weeks is characterized by a UACR reduction of at least 29%.

59 . The method of claim 42 , wherein the administration provides the improved glycemic control, the attenuated rate of eGFR decline, and the reduced UACR at both 26 and 52 weeks.

Assignees

• Lilly Co Eli

Inventors

• Botros Fady Talaat
• Lakshmanan Mark Chandrakant
• Tuttle Katherine Rose
• Zimmermann Alan George George

Classifications

• G01N2800/347

  Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy · CPC title

• G01N2333/76

  Assays involving albumins other than in routine use for blocking surfaces or for anchoring haptens during immunisation · CPC title

• G01N33/6893

  related to diseases not provided for elsewhere · CPC title

• A61K45/06 Primary

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K38/556

  Angiotensin converting enzyme inhibitors · CPC title