GIP / GLP1 agonist composition

Abstract

To provide a pharmaceutical GIP / GLP1 co-agonist peptide composition for subcutaneous injection.SOLUTION: A pharmaceutical composition for treating diabetes comprises: tirzepatide, or a pharmaceutically acceptable salt thereof; an agent selected from the group consisting of NaCl and propylene glycol; and dibasic sodium phosphate.SELECTED DRAWING: None

Description

[Background technology]

[0001] The present invention is a pharmaceutical GIP / GLP1 coagonist peptide composition for subcutaneous injection. The composition comprises tirzepatide, NaCl, and dibasic sodium phosphate. The product provides commercially acceptable shelf-life stability, in-use stability, and acceptable patient The alternative composition is tirzepatide, propylene glycol and dibasic sodium phosphate, which also provides acceptable shelf-life stability. .

[0002] Diabetes mellitus is hyperglycemia caused by defects in insulin secretion, insulin action, or both. Type 2 diabetes ("T2D") is a chronic disease characterized by insufficient insulin secretion and The combined effects of hypercalcemia and insulin resistance are associated with elevated blood glucose levels. Patid is a GIP / GLP1 co-agonist peptide useful in the treatment of diabetes. Patides are useful in the treatment of obesity.

[0003] US9474780 is a GIP / GLP drug that is generally administered by parenteral route. US9474780 describes compositions containing tirzepatide. Describes and claims acceptable stability and acceptable patient injection site experience. Compositions of tirzepatide which provide the following are desirable.

[0004] The present invention relates to a pharma- ceutical acceptable composition of tirzepatide or a pharma- ceutical acceptable salt thereof. The composition comprises an agent selected from the group consisting of NaCl and propylene glycol, and These needs are addressed by providing a composition comprising: is attempting to fill.

[0005] In one embodiment, the agent is NaCl. In one embodiment, the NaCl concentration is about 6. 2 mg / mL to about 9.5 mg / mL. In one embodiment, the NaCl concentration is about 7.0 mg / mL to about 9.0 mg / mL. In one embodiment, the NaCl concentration is about 8.2 m g / mL.

[0006] In one embodiment, the agent is propylene glycol. In one embodiment, propylene glycol concentration is about 12.0 mg / mL to about 18.0 mg / mL. In one embodiment the propylene glycol concentration is about 14.0 mg / mL to about 16.0 mg / mL . In one embodiment, the propylene glycol concentration is about 15.0 mg / mL.

[0007] In one embodiment, the dibasic sodium phosphate concentration is about 0.67 mg / mL to about 2.6 8 mg / mL. In one embodiment, the dibasic sodium phosphate is about 1.0 mg / m L to about 3.0 mg / mL. In one embodiment, the dibasic sodium phosphate is about 1. 34 mg / mL.

[0008] In one embodiment, the tiludronate concentration is about 5 mg / mL to about 30 mg / mL, and the agent is NaCl. In one embodiment, the tiludronate concentration is about 10 mg / mL to about 3 0 mg / mL. In one embodiment, the tiludronate concentration is about 5 mg / mL to about 30 m g / mL, the NaCl concentration is about 8.2 mg / mL, and the dibasic sodium phosphate concentration is about 0.67 mg / mL to about 2.68 mg / mL. In one embodiment, til The concentration of zepotid is from about 5 mg / mL to about 30 mg / mL, the concentration of NaCl is about 8.2 mg / mL, and the concentration of dibasic sodium phosphate is from about 0.67 mg / mL to about 2.6 8 mg / mL, and the composition is provided in a single-use auto-injector device.

[0009] In one embodiment, the concentration of zepotid is from about 5 mg / mL to about 30 mg / mL, and the drug is propylene glycol. In one embodiment, zepotid is from about 5 mg / mL to about 30 mg / mL, and propylene glycol is from about 12.0 mg / mL to about 18. 0 mg / mL, and the concentration of dibasic sodium phosphate is about 1.34 mg / mL. In one embodiment, the concentration of zepotid is from about 5 mg / mL to about 30 mg / mL, and pro pylene glycol is about 15.0 mg / mL, and the concentration of dibasic sodium phosphate is about 1.34 mg / mL.

[0010] In one embodiment, the concentration of zepotid is from about 5 mg / mL to about 30 mg / mL. In particular embodiments, the concentration of zepotid is from about 10 mg / mL to about 30 mg / mL. In one embodiment, the concentration of zepotid is selected from the group consisting of 5, 10, 15, 20, 25, and 30 mg / mL. In one embodiment, a composition of 0.5 mL or less is administered as a dose. In one embodiment, the concentration of zepotid is selected from the group consisting of 10, 20, and 30 mg / m L.

[0011] In one embodiment, the zepotid composition further comprises a preservative. In one embodiment, the til zepotid composition comprises zepotid, dibasic sodium phosphate, propylene glycol, and contains a preservative. In one embodiment, the preservative is selected from the group consisting of metacresol and phenol. In one embodiment, the metacresol concentration is from about 2.0 mg / mL to about 4.0 mg / mL. In one embodiment, the metacresol concentration is from about 3.0 mg / m L to about 3.5 mg / mL. In one embodiment, the metacresol concentration is about 3.15 m g / mL. In one embodiment, the phenol concentration is from about 3.0 mg / mL to about 7.0 m g / mL. In one embodiment, the phenol concentration is from about 4.0 mg / mL to about 6.0 m g / mL. In one embodiment, the phenol concentration is about 5.0 mg / mL. In one embodiment, a tilzeyapatide composition is provided, wherein the tilzeyapatide concentration is from about 5 mg / mL to about 30 mg / mL, the propylene glycol concentration is from about 12.0 mg / mL to about 18. 0 mg / mL, the dibasic sodium phosphate concentration is from about 0.67 to about 2.68 mg / mL, and the metacresol concentration is from about 2.0 mg / mL to about 4.0 mg / mL. In one embodiment, the metacresol concentration is about 3.15 mg / mL. In one embodiment , a tilzeyapatide composition is provided, wherein the tilzeyapatide concentration is from about 5 mg / mL to about 30 mg / mL, the propylene glycol concentration is from about 12.0 mg / mL to about 18.0 mg / m L, the dibasic sodium phosphate concentration is from about 0.67 to about 2.68 mg / mL, and , the phenol concentration is from about 3.0 mg / mL to about 7.0 mg / mL. In one embodiment , a tilzeyapatide composition is provided, wherein the tilzeyapatide concentration is from about 5 mg / mL to about 30 mg / mL, the propylene glycol concentration is from about 12.0 mg / mL to about 18.0 mg / m L, the dibasic sodium phosphate concentration is from about 0.67 to about 2.68 mg / mL, and The phenol concentration is about 5.0 mg / mL.

[0012] In one embodiment, the dose of the tilsepamate composition is administered about once a week. In one embodiment, the dose of the tilsepamate composition is administered once every 7 days.

[0013] In one embodiment, a method of treating diabetes is provided, which includes administering to a human in need thereof an effective dose of one of the above compositions.

[0014] In one embodiment, a method of treating obesity is provided, which includes administering to a human in need thereof an effective dose of one of the above compositions. In one embodiment, a method of providing therapeutic weight loss is provided, which includes administering to a human in need thereof an effective dose of one of the above compositions. In one embodiment, a method of treating a condition mediated by GIP / GLP1 co-agonist activity is provided, which includes administering to a human in need thereof an effective dose of one of the above compositions.

[0015]

[0016] In one embodiment, one of the above compositions is provided for use as a medicament.

[0016] In one embodiment, one of the above compositions is provided for use in the treatment of diabetes. In one embodiment, one of the above compositions is provided for use in the treatment of obesity.

[0017] In one embodiment, one of the above compositions is provided for use in providing therapeutic weight loss. In one embodiment, one of the above compositions is provided for use in providing non-therapeutic weight loss. ​​

[0018] According to another aspect of the present invention, there is provided a manufactured article comprising one of the above compositions. In particular in certain embodiments, the manufactured article is a multi-use vial. In certain embodiments, the manufactured article is a prefilled syringe. In certain embodiments, the manufactured article is an auto-injector ("autoinjector"). An example of an autoinjector contemplated herein is U.S. Patent No. 8, 734,394.

[0019] As used herein, "tilsempetide" refers to the GIP / GLP1 co agonist peptide described in US9,474,780 and identified by CAS Registry Number: 2023788-19-2. Tilsempetide has the following sequence and is described in Example 1 of US9474,780: YX1EGTFTSDYSIX2LDKIAQKAFVQWLIAGGPSSGAPPP S wherein X1 is Aib, X2 is Aib, the K at position 20 is chemically modified through the epsilon-amino group of the K side chain to (2-[2-(2 -amino-ethoxy)-ethoxy]-acetyl)2-(γGlu)1-CO-(CH2) 18-CO2H, and the C-terminal amino acid is amidated as a C-terminal primary amide (SEQ ID NO: 1).

[0020] As used herein, "pharmaceutically acceptable salt" is well known to those skilled in the art. In one embodiment, it is a pharmaceutically acceptable salt that is the tilsempetide trifluoroacetate salt.

[0021] As used herein, the term "surfactant-free" means that the composition does not contain added This means that it contains no surfactant or only a small amount of added surfactant. do.

[0022] As used herein, the term "propylene glycol" refers to a compound known to those skilled in the art. be.

[0023] Propylene glycol is also represented by the formula: C3H8O2.

[0024] The composition of the present invention has a concentration of tirzepatide 30 of 5 mg / mL to 30 mg / mL. The compositions of the present invention are available in specific concentrations of 5, 10, 15, 20, 25, and 30 mg / mL. Such compositions may be provided in a pre-filled syringe. Such prefilled syringes contain 0.5 milliliters per patient dose. It may be useful to administer such a composition to a patient in need thereof. The dosage may be administered using a dosing schedule determined by

[0025] The composition is sterile when first manufactured. Multi-use vials or cartridges When provided in a pharmaceutical composition, the composition is provided with an antimicrobial preservative compound or mixture of compounds that is compatible with the other components of the composition. The compounds may be added in sufficient strength to meet applicable regulatory antimicrobial preservative requirements. Acceptable preservatives are well known in the art. n:The Science and Practice of Pharmacy(D .B. Troy, Editor, 21st Edition, Lippincott, W (See, e.g., Iliams & Wilkins, 2006). In one embodiment, the preservative In one embodiment, the preservative is phenol. The composition for the refill syringe does not require a preservative. In one embodiment, the composition does not contain a surfactant.

[0026] The pH of the tilsepamate composition of the present invention is typically 6.5 to 7.5, and physiological appropriate acids and bases are used to adjust as may be required to achieve the desired p H. In one embodiment, the pH target is 6.7 to 7.3. The patient's experience at the injection site is a consideration for the composition administered subcutaneously. It is desirable to select a composition associated with an acceptable patient injection site experience. For example, NaCl and citrate are associated with a stinging sensation with pain at the injection site. (Laursen, T.; Hansen, B.; Fisker, S. Pain perception after subcutaneous injections of media containing different buffers. Basic & Clinical Pharmacology & Toxicology 2006, 98, (2), 218 - 221.), (Fransson, J.; Espander - Jansson, A. Local tolerance of subcutaneous injections. Journal of Pharmacy and Pharmacology 1996, 48, (10), 101 2 - 1015.) Solutions that are not approximately isotonic with body fluids can cause a stinging sensation with pain when administered, so it is further desirable to match the tonicity (i.e., osmotic pressure) of the body fluid at the injection site as closely as possible when administering the composition. The composition is approximately isotonic with body fluid at the injection site. It is desirable to contain. It contains tilsertide, NaCl, and disodium phosphate This composition is associated with the acceptable injection site experience of the patient. Similarly, a composition containing tilsertide , propylene glycol, and disodium phosphate is associated with the acceptable injection site experience of the patient.

[0027] In one embodiment, the pH is adjusted using a base to facilitate dissolution in the buffer solution . The addition of an acid to the composition may be required to adjust the pH to the desired pH range. One In an embodiment, NaOH is used to facilitate the dissolution of tilsertide in the buffer . In one embodiment, HCl is added to adjust the pH of the composition containing dissolved tilsertide to the desired pH range.

[0028] The composition of the present invention is typically administered subcutaneously. The composition is typically administered using a prefilled disposable pen, a reusable pen, or an autoinjector pen. The composition can be administered using a multi-use vial or a pump device. In one embodiment , the device is an autoinjector device described by U.S. Patent No. 8,734,394 .

[0029] A composition containing tilsertide, NaCl, and disodium phosphate provides desirable shelf-life stability and provides an acceptable injection site experience for the patient. Similarly, a composition containing til sertide, propylene glycol, and disodium phosphate provides desirable shelf-life stability and provides an acceptable injection site experience for the patient. As used in this specification , "shelf-life stability" is measured under controlled conditions at about 5 degrees Celsius A composition comprising tilzepide, NaCl, and dibasic sodium phosphate provides stability during acceptable use. Similarly, a composition comprising tilzepide, propylene glycol, and dibasic sodium phosphate provides stability during acceptable use. As used herein, the term "stability during use" refers to the stability of the composition measured under controlled conditions at about 25 °C or about 40 °C. A composition comprising tilzepide, propylene glycol, and dibasic sodium phosphate provides stability during acceptable use. A composition comprising tilzepide, propylene glycol, and dibasic sodium phosphate provides stability during acceptable use. As used herein, the term "stability during use" refers to the stability of the composition measured under controlled conditions at about 25 °C or about 40 °C. As used herein, the term "stability during use" refers to the stability of the composition measured under controlled conditions at about 25 °C or about 40 °C. As used herein, the term "stability during use" refers to the stability of the composition measured under controlled conditions at about 25 °C or about 40 °C.

[0030] Example #1 - Composition Containing NaCl The composition is prepared substantially as described herein. Compositions containing 5, 10, 15, 20, 15, and 30 mg / mL of tilzepide each contain the components listed in Table 1. An acid or base is optionally added to achieve the desired pH range. Water is added in an appropriate amount (q.s.) to a total final volume of 1 milliliter. Compositions containing 5, 10, 15, 20, 15, and 30 mg / mL of tilzepide each contain the components listed in Table 1. An acid or base is optionally added to achieve the desired pH range. Water is added in an appropriate amount (q.s.) to a total final volume of 1 milliliter. An acid or base is optionally added to achieve the desired pH range. Water is added in an appropriate amount (q.s.) to a total final volume of 1 milliliter. An acid or base is optionally added to achieve the desired pH range. Water is added in an appropriate amount (q.s.) to a total final volume of 1 milliliter. [Table 1]

[0031] Example #2 - Composition Containing Propylene Glycol The composition is prepared substantially as described herein. Compositions providing 5, 10, 15, 20, 15, and 30 mg / mL of tilzepide each contain the components listed in Table 2. An acid or base is optionally added to achieve the desired pH range. Water is added in an appropriate amount to a total final volume of 1 milliliter. Compositions providing 5, 10, 15, 20, 15, and 30 mg / mL of tilzepide each contain the components listed in Table 2. An acid or base is optionally added to achieve the desired pH range. Water is added in an appropriate amount to a total final volume of 1 milliliter. An acid or base is optionally added to achieve the desired pH range. Water is added in an appropriate amount to a total final volume of 1 milliliter. An acid or base is optionally added to achieve the desired pH range. Water is added in an appropriate amount to a total final volume of 1 milliliter. [Table 2]

[0032] Stability Test During Size Exclusion Chromatography (SEC) This procedure is a gradient size exclusion HPLC method with UV detection at 214 nm and is designed to determine the relative amounts of the tiludronate monomer and total aggregates. The monomer and aggregates are reported as peak area percentages relative to the total area. The procedure demonstrates stability as measured by its ability to degrade known impurities from tiludronate. This test compares an alternative composition with the composition of the present invention prepared as shown in Table 3. The stability from this test is shown in Table 4. Stability test comparing alternative compositions:

Table 3

Table 4

[0033] Stability test for shelf life RP-HPLC: This procedure is a gradient reverse phase HPLC method with UV detection at 214 nm and is designed to determine the amount, identity, and purity of tiludronate in a drug product. Identity is determined by matching the retention time of the main peak in the sample with the retention time of the main peak of an external reference standard. The amount is determined by comparison of the main peak area with the corresponding peak in the external reference standard. Impurities and related substances are reported as peak area percentages relative to the total area. The procedure demonstrates stability as judged by its ability to degrade known impurities from tiludronate. As shown in Table 4, compositions containing NaCl as an isotonic agent provide acceptable stability during use.

[0034] Stability test for size exclusion chromatography (SEC) shelf life​​​​​​​​​​​​ The size exclusion stability test method and RP-HPLC described in this specification are applied to compare a composition containing NaCl as an isotonic agent and a stabilizer with a composition containing propylene glycol as an isotonic agent and a stabilizer. This test exemplifies the acceptable shelf life stability of the composition of the present invention containing an NaCl agent or propylene glycol as a drug. The compositions used in this test are described in Table 5. The stability from this test is shown in Table 6.

Table 5

Table 6

[0035] Post-injection pain test: All compositions are prepared as described in Table 7. Each solution composition vial is held at room temperature for about 30 minutes, although for 4 hours or less. The lyophilized composition is reconstituted and used immediately. All injections are rotated among the four quadrants of the abdomen in the following order: lower left quadrant, lower right quadrant, upper left quadrant, and upper right quadrant. A syringe with a 29-gauge needle is used to administer the composition from the vial. The skin at the injection site is pinched by the subject and the needle is inserted at an angle of about 45 degrees. A second person measures the length of the injection time using a stopwatch. The subject slowly pushes the plunger of the syringe until 0.5 mL of the composition is injected. The target injection time is a duration of 4 seconds and is 5 seconds or less. The needle is removed from the skin after injection and the skin is released from the subject's pinch. The subject evaluates the pain immediately after each injection. Pain ​​​​​​​​​​​​​​The measurement is evaluated using a 100 - mm validated visual analog scale (VAS) for pain . The VAS is a well - validated tool for assessing pain at the injection site (Willi amson, A.; Hoggart, B. Pain: A review of thre e commonly used pain rating scales. Journ al of Clinical Nursing 2005, 14, (7), 798 - 8 04). The VAS is presented as a 10 - cm (100 - mm) line fixed by language descriptors, usually "no pain" and "worst imaginable pain" . Subjects are asked to mark the 100 - mm line to indicate the pain intensity as clinically demonstrated at the time point. Staff members use calipers to measure the distance from 0 to the mark placed by the subject on the VAS and record the measurement in the source document. The results from this test are shown in Table 8. The acceptable patient experience at the injection site is reflected by an indicator of mild pain intensity (compared to moderate or severe).

Table 7

Table 8

Table 9

Table 10

[0036] Sequence SEQ ID NO: 1 Tiluepaptide YX1EGTFTSDYSIX2LDKIAQKAFVQWLIAGGPSSGAPPPS In the formula, X1 is Aib, X2 is Aib, the K at the 20th position is chemically modified through the bond to the epsilon-amino group of the K side chain with (2-[2-(2-amino-ethoxy)-ethoxy]-acetyl)2-(γGlu)1-CO-(CH2)18-CO2H, and the C-terminal amino acid is amidated as a C-terminal primary amide. Various embodiments of the present invention are shown below. 1. A pharmaceutical composition comprising tiltideptide, or a pharmaceutically acceptable salt thereof, a drug selected from the group consisting of NaCl and propylene glycol, and dibasic sodium phosphate. 2. The pharmaceutical composition according to 1 above, wherein the concentration of the tiltideptide, or a pharmaceutically acceptable salt thereof, is about 5 to about 30 mg / mL. 3. The pharmaceutical composition according to 2 above, wherein the dibasic sodium phosphate concentration is about 1.0 mg / mL to about 3.0 mg / mL. 4. The pharmaceutical composition according to 3 above, wherein the dibasic sodium phosphate concentration is about 0.67 mg / mL to about 2.68 mg / mL. 5. The pharmaceutical composition according to 4 above, wherein the dibasic sodium phosphate concentration is about 1.34 mg / mL. 6. The pharmaceutical composition according to 1 above, wherein the concentration of the tiltideptide, or a pharmaceutically acceptable salt thereof, is selected from the group consisting of 5, 10, 15, 20, 25, and 30 mg / mL. 7. The pharmaceutical composition according to 6 above, wherein the concentration of the tiltideptide, or a pharmaceutically acceptable salt thereof, is selected from the group consisting of 10, 20, and 30 mg / mL. 8. The pharmaceutical composition according to 7 above, wherein the drug is NaCl. 9. The pharmaceutical composition according to 8 above, wherein the NaCl concentration is about 6.2 mg / mL to about 9.5 mg / mL. 10. The pharmaceutical composition according to 9 above, wherein the NaCl concentration is about 7.0 mg / mL to about 9.0 mg / mL. 11. The pharmaceutical composition according to 10 above, wherein the NaCl concentration is about 8.2 mg / mL. 12. The pharmaceutical composition according to 1 above, wherein the concentration of the tiltideptide, or a pharmaceutically acceptable salt thereof, is about 5 mg / mL to about 30 mg / mL, the dibasic sodium phosphate concentration is about 0.67 mg / mL to about 2.68 mg / mL, and the NaCl concentration is about 6.2 mg / mL to about 9.5 mg / mL. 13. The pharmaceutical composition according to 12 above, wherein the concentration of the tiltideptide, or a pharmaceutically acceptable salt thereof, is about 5 mg / mL to about 30 mg / mL, the dibasic sodium phosphate concentration is about 1.34 mg / mL, and the NaCl concentration is about 8.2 mg / mL. 14. The pharmaceutical composition according to 13 above, wherein the composition is provided in an auto-injector device. 15. The pharmaceutical composition according to 1 above, wherein the drug is propylene glycol. 16. The pharmaceutical composition according to 15 above, wherein the concentration of the propylene glycol is from about 12.0 mg / mL to about 18.0 mg / mL. 17. The pharmaceutical composition according to 16 above, wherein the concentration of the propylene glycol is from about 14.0 mg / mL to about 16.0 mg / mL. 18. The pharmaceutical composition according to 17 above, wherein the concentration of the propylene glycol is about 15.0 mg / mL. 19. The pharmaceutical composition according to 1 above, wherein the concentration of tildepazide, or a pharmaceutically acceptable salt thereof, is from about 5 mg / mL to about 30 mg / mL, the concentration of dibasic sodium phosphate is from about 0.67 mg / mL to about 2.68 mg / mL, and the concentration of propylene glycol is from about 14.0 mg / mL to about 16.0 mg / mL. 20. The pharmaceutical composition according to 19 above, wherein the concentration of tildepazide, or a pharmaceutically acceptable salt thereof, is from about 5 mg / mL to about 30 mg / mL, the concentration of dibasic sodium phosphate is about 1.34 mg / mL, and the concentration of propylene glycol is about 15.0 mg / mL. 21. The pharmaceutical composition according to 20 above, wherein the composition is provided in an auto-injector device. 22. The pharmaceutical composition according to 21 above, wherein the pH of the composition is from about 6.5 to about 7.5. 23. The pharmaceutical composition according to 22 above, wherein the pH is from about 6.7 to about 7.3. 24. The pharmaceutical composition according to 23 above, further comprising one or more preservatives. 25. The pharmaceutical composition according to 24 above, wherein the composition further comprises a preservative selected from the group consisting of metacresol and phenol. 26. The pharmaceutical composition according to 25 above, wherein the preservative is metacresol. 27. The pharmaceutical composition according to 26 above, wherein the concentration of metacresol is from about 2.0 mg / mL to about 4.0 mg / mL. 28. The pharmaceutical composition according to 27 above, wherein the concentration of metacresol is about 3.15 mg / mL. 29. The pharmaceutical composition according to 25 above, wherein the preservative is phenol. 30. The pharmaceutical composition according to 29 above, wherein the concentration of phenol is from about 3.0 mg / mL to about 7.0 mg / mL. 31. The pharmaceutical composition according to 30 above, wherein the concentration of phenol is about 5.0 mg / mL. 32. The pharmaceutical composition according to 1 above, wherein the concentration of tildepazide or a pharmaceutically acceptable salt thereof is from about 5 mg / mL to about 30 mg / mL, the dibasic sodium phosphate is from about 0.67 to about 2.68 mg / mL, the propylene glycol is from about 12.0 mg / mL to about 15.0 mg / mL, and further contains from about 2.0 mg / mL to about 4.0 mg / mL of metacresol. 33. The pharmaceutical composition according to 1 above, wherein the concentration of tildepazide or a pharmaceutically acceptable salt thereof is from about 5 mg / mL to about 30 mg / mL, the dibasic sodium phosphate is from about 0.67 to about 2.68 mg / mL, the propylene glycol is from about 12.0 mg / mL to about 18.0 mg / mL, and further contains from about 3.0 mg / mL to about 7.0 mg / mL of phenol. 34. The pharmaceutical composition according to 33 above, wherein the volume of the composition dosage is about 0.5 mL. 35. The pharmaceutical composition according to 34 above, wherein the composition is administered using an auto-injection device. 36. A method for treating diabetes, comprising administering to a human in need thereof an effective dose of the pharmaceutical composition according to 33 above. 37. The method for treating diabetes according to 36 above, wherein the dose is administered using an auto-injection device. 38. The method for treating diabetes according to 37 above, wherein the dose is administered once a week. 39. A method for treating obesity, comprising administering to a human in need thereof an effective dose of the pharmaceutical composition according to 33 above. 40. The method for treating obesity according to 39 above, wherein the dose is administered using an auto-injection device. 41. The method for treating obesity according to 40 above, wherein the dose is administered once a week. 42. The pharmaceutical composition according to 33 above for use in the treatment of diabetes. 43. The pharmaceutical composition according to 33 above for use in the treatment of obesity.

Claims

1. Tirzepatide, or a pharmaceutically acceptable salt thereof, and a drug selected from the group consisting of NaCl and propylene glycol, and sodium dibasic phosphate, for treating diabetes, a pharmaceutical composition.

2. The composition according to claim 1, administered using an auto-injector device.

3. The composition according to claim 1, for treating obesity.

4. The composition according to claim 3, administered using an auto-injector device.

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