Corcept Stops Phase 2 NASH Study With Miricorilant Due To Elevated Liver Enzymes In Patients

Corcept Therapeutics Incorporated CORT has announced interim data from the Phase 2 trial evaluating its selective cortisol modulator miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).
The company had to suspend the trial after most patients who received the therapy had elevated liver enzymes.
“When we observed elevated ALT and AST levels in four of the first five patients who received miricorilant for four weeks, we suspended the study,” commented Dr. Andreas Grauer Corcept’s Chief Medical Officer.
ALT and AST are liver enzymes, and their elevations indicate the inflammation or injury to liver cells.
The rise in enzymes was resolved after miricorilant was withdrawn, the company said.
Around 30% reduction in liver fat at week 12 was the primary endpoint of the trial for which the company targeted to enroll 120 patients.
“These patients exhibited much larger reductions after receiving miricorilant for 4-6 weeks,” Grauer added.
“Liver fat reductions achieved this quickly and of this magnitude are rarely seen,” noted Dr. Stephen A. Harrison, the lead investigator of the study. He called for further research to see if miricorilant can significantly and safely reduce liver fat with a meaningful improvement in NASH.
Price Action: CORT shares closed 0.2% lower at $21.71 on Thursday.