# US 12,214,017 B2 · GLP-1 compositions and uses thereof

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- Number: US 12,214,017 B2
- Document ID: US12214017B2
- Status: Granted
- Kind: B2
- Application number: 18/427,270
- Filed: 2024-01-30
- Published: 2024-07-04
- Granted: 2025-02-04
- Earliest claimed: 2017-08-24
- Assignees: Novo Nordisk A/S
- Applicants: Novo Nordisk A/S
- Inventors: Eva Horn Moeller; Michael Duelund Soerensen; Joakim Lundqvist
- Web page: https://patentgrep.com/patent/US12214017B2

## CPC

- A61K 38/26: Glucagons
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 47/02: Inorganic compounds
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to pharmaceutical compositions of the GLP-1 peptide semaglutide comprising no more than 0.01% (w/w) phenol, their preparation, kits comprising such compositions as well as uses thereof.

## Claims

### Claim 1

A liquid pharmaceutical composition comprising:
semaglutide;
wherein said composition
(a) does not contain phenol; and
(b) is administered parenterally; and
(c)(i) is an aqueous solution comprising at least 60% (w/w) water or (ii)
further comprises one or more pharmaceutically acceptable excipients selected from the group consisting of a buffer or an isotonic agent; and
wherein the semaglutide is in the range of 0.01 mg/ml-10.0 mg/ml; and
wherein the pH of the composition is in between 7.0 and 7.8.

### Claim 2 (depends on 1)

The liquid pharmaceutical composition according to claim 1, wherein the concentration of semaglutide is selected from 0.5-10 mg/ml or 0.01-5 mg/ml of said composition.

### Claim 3 (depends on 1)

The liquid pharmaceutical composition according to claim 1, wherein said composition comprises no added pharmaceutical preservative.

### Claim 4 (depends on 1)

The liquid pharmaceutical composition according to claim 1, wherein said parenteral administration is subcutaneous administration.

### Claim 5 (depends on 1)

A kit comprising the liquid pharmaceutical composition according to claim 1 and instructions for use.

### Claim 6 (depends on 1)

A kit comprising the liquid pharmaceutical composition according to claim 1 and an injection device for administration of said composition to a subject, wherein said injection device is selected from the group consisting of a durable pen and a prefilled pen.

### Claim 7 (depends on 1)

A method of treating diabetes comprising administering to a subject in need of such method a therapeutically effective amount of the pharmaceutical composition according to claim 1.

### Claim 8 (depends on 1)

A method of treating obesity comprising administering to a subject in need of such method a therapeutically effective amount of the pharmaceutical composition according to claim 1.

### Claim 9 (depends on 1)

The liquid pharmaceutical composition according to claim 1, wherein said composition has a pH in the range of 7.0-7.4.