Combination therapy comprising an ACC inhibitor
The present disclosure provides methods and compositions for treating, stabilizing or lessening the severity or progression of a non-alcoholic fatty liver disease.
1. A method of treating, stabilizing or lessening the severity or progression of non-alcoholic steatohepatitis (NASH), wherein the method comprises administering to a human patient in need thereof Compound 1 having the formula:
or a pharmaceutically acceptable salt thereof,
in combination with fenofibrate, or a salt thereof, and wherein the human patient has F3-F4 NASH fibrosis and the human patient has a plasma triglyceride level of at least about 150 mg/dL; and
wherein Compound 1 is administered in an amount of about 20 mg.
2. A method of treating, stabilizing or lessening the severity or progression of non-alcoholic steatohepatitis (NASH) while lessening the severity of hypertriglyceridemia, wherein the method comprises administering to a human patient in need thereof Compound 1 having the formula:
or a pharmaceutically acceptable salt thereof,
in combination with fenofibrate, or a salt thereof, and wherein the human patient has F3-F4 NASH fibrosis and the human patient has a plasma triglyceride level of at least about 150 mg/dL; and
wherein Compound 1 is administered in an amount of about 20 mg.
3. The method according to claim 1 , wherein the human patient has compensated cirrhosis due to NASH.
4. The method according to claim 2 , wherein the human patient has compensated cirrhosis due to NASH.
5. The method according to claim 2 , wherein about 48 mg of fenofibrate is administered per day.
6. The method according to claim 2 , about 145 mg of fenofibrate is administered per day.
7. The method according to claim 1 , about 48 mg of fenofibrate is administered per day.
8. The method according to claim 1 , wherein about 145 mg of fenofibrate is administered per day.
9. The method according to claim 6 , further comprising administering an FXR agonist.
10. The method according to claim 8 , further comprising administering an FXR agonist.
11. The method of claim 1 , wherein administration of fenofibrate starts before administration of Compound 1 and optionally continues during at least part of the administration of Compound 1.
12. The method of claim 2 , wherein administration of fenofibrate starts before administration of Compound 1 and optionally continues during at least part of the administration of Compound 1.
13. The method of claim 9 , wherein the FXR agonist is administered at a dosage of about 30 mg per day.
14. The method of claim 10 , wherein the FXR agonist is administered at a dosage of about 30 mg per day.
15. The method according to claim 1 , wherein fenofibrate is administered at a dosage of about 30 mg to about 200 mg per day.
16. The method according to claim 2 , wherein fenofibrate is administered at a dosage of about 30 mg to about 200 mg per day.
17. The method according to claim 9 , wherein the FXR agonist is obeticholic acid or PX-102.
18. The method according to claim 10 , wherein the FXR agonist is obeticholic acid or PX-102.
19. The method of claim 1 , wherein administration of fenofibrate and administration of Compound 1 are simultaneous.
20. The method of claim 2 , wherein administration of fenofibrate and administration of Compound 1 are simultaneous.