IP Library › Granted Patent US 12,377,104
Granted Patent B1
US 12,377,104 · App. 19/045,070 · Granted Aug 5, 2025

Methods for treating a fatty liver disease

Inventors: Rebecca Taub (Villanova, PA); Dominic Labriola (Belmar, NJ)
Assignee: Madrigal Pharmaceuticals, Inc.
A61K31/53A61P1/16
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Quick Facts
Patent No.
US 12,377,104
App. No.
19/045,070
Filed
Feb 4, 2025
Granted
Aug 5, 2025
Kind
B1
Art Unit
1629
USPC
514/252.02
Abstract

The present disclosure provides a method of treating a fatty liver disease (e.g., non-alcoholic steatohepatitis (NASH)) in a human subject (e.g., an adult human subject) in need of such treatment (e.g., NASH/improving liver fibrosis) with 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile (resmetirom) or a pharmaceutically acceptable salt thereof. The present disclosure also provides a method of improving liver fibrosis in a human subject (e.g., an adult human subject) in need of such treatment (e.g., NASH/improving liver fibrosis) with 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile (resmetirom) or a pharmaceutically acceptable salt thereof.

Claims (33)

1. A method of treating nonalcoholic steatohepatitis (NASH), comprising:

determining a weight of an adult human subject in need thereof, and

based on determination of the weight of the adult human subject in need thereof, administering to the adult human subject in need thereof a solid oral dosage form comprising:

(i) resmetirom or a pharmaceutically acceptable salt thereof at a dosage of 100 mg per day, if the adult human subject in need thereof is determined to weigh 100 kg or more; or

(ii) resmetirom or the pharmaceutically acceptable salt thereof at a dosage of 80 mg per day, if the adult human subject in need thereof is determined to weigh less than 100 kg.

2. The method according to claim 1 , wherein the adult human subject in need thereof is determined to weigh 100 kg or more and is administered the solid oral dosage form comprising resmetirom or the pharmaceutically acceptable salt thereof at the dosage of 100 mg per day.

3. The method according to claim 1 , wherein the adult human subject in need thereof is determined to weigh less than 100 kg and is administered the solid oral dosage form comprising resmetirom or the pharmaceutically acceptable salt thereof at the dosage of 80 mg per day.

4. The method according to claim 1 , wherein the solid oral dosage form is a tablet.

5. The method according to claim 4 , wherein the solid oral dosage form comprises resmetirom.

6. The method according to claim 2 , wherein the solid oral dosage form is a tablet.

7. The method according to claim 6 , wherein the solid oral dosage form comprises resmetirom.

8. The method according to claim 3 , wherein the solid oral dosage form is a tablet.

9. The method according to claim 8 , wherein the solid oral dosage form comprises resmetirom.

10. A method of improving liver fibrosis comprising:

determining a weight of an adult human subject in need thereof; and

based on determination of the weight of the adult human subject in need thereof, administering to the adult human subject in need thereof a solid oral dosage form comprising:

(i) resmetirom or a pharmaceutically acceptable salt thereof at a dosage of 100 mg per day, if the adult human subject in need thereof is determined to weigh 100 kg or more; or

(ii) resmetirom or the pharmaceutically acceptable salt thereof at a dosage of 80 mg per day, if the adult human subject in need thereof is determined to weigh less than 100 kg; and

wherein the adult human subject in need thereof has nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis consistent with stages F2 to F3.

11. The method according to claim 10 , wherein the adult human subject in need thereof is determined to weigh 100 kg or more and is administered the solid oral dosage form comprising resmetirom or the pharmaceutically acceptable salt thereof at the dosage of 100 mg per day.

12. The method according to claim 10 , wherein the adult human subject in need thereof is determined to weigh less than 100 kg and is administered the solid oral dosage form comprising resmetirom or the pharmaceutically acceptable salt thereof at the dosage of 80 mg per day.

13. The method according to claim 10 , wherein the method is of improving the liver fibrosis by at least one stage in the adult human subject in need thereof.

14. The method according to claim 11 , wherein the method is of improving the liver fibrosis by at least one stage in the adult human subject in need thereof.

15. The method according to claim 12 , wherein the method is of improving the liver fibrosis by at least one stage in the adult human subject in need thereof.

16. The method according to claim 13 , wherein the solid oral dosage form is a tablet.

17. The method according to claim 16 , wherein the solid oral dosage form comprises resmetirom.

18. The method according to claim 14 , wherein the solid oral dosage form is a tablet.

19. The method according to claim 18 , wherein the solid oral dosage form comprises resmetirom.

20. The method according to claim 15 , wherein the solid oral dosage form is a tablet.

21. The method according to claim 20 , wherein the solid oral dosage form comprises resmetirom.

22. The method according to claim 13 , wherein the adult human subject in need thereof has liver fibrosis characterized as fibrosis stage F3.

23. The method according to claim 14 , wherein the adult human subject in need thereof has liver fibrosis characterized as fibrosis stage F3.

24. The method according to claim 15 , wherein the adult human subject in need thereof has liver fibrosis characterized as fibrosis stage F3.

Assignments (2)
SECURITY INTEREST Recorded Jul 17, 2025
From: MADRIGAL PHARMACEUTICALS, INC.
To: LSI FINANCING LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 072038/0693 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 12, 2025
From: TAUB, REBECCA; LABRIOLA, DOMINIC
To: MADRIGAL PHARMACEUTICALS, INC.
Reel/Frame 071394/0422 →
Continuity (3)
Provisional Application 63550201 · Feb 6, 2024
Provisional Application 63564803 · Mar 13, 2024
Provisional Application 63655870 · Jun 4, 2024
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US 12,667,575