Corcept Therapeutics Observes Large Reductions of Liver Fat and Transient Liver Enzyme Elevations in Phase 2 Trial of Miricorilant as a Potential Treatment for Patients with Nonalcoholic Steatohepatitis (NASH)
“This was our first trial to evaluate miricorilant as a treatment for patients with liver disease. 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,” said
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“Second, the patients with elevated liver enzymes exhibited large reductions in liver fat rapidly.” (See Table 1)
Patient | Miricorilant (per day) |
Days on Drug |
% Liver Fat at Baseline |
% Liver Fat at Follow up |
Days Between Last Dose and Follow-up |
Relative Reduction in % Liver Fat |
|
Patient 1 | 900 mg | 30 | 17.6 | 6.1 | 19 | -65.3 | % |
Patient 2 | 900 mg | 31 | 27.8 | 17.1 | 64 | -38.5 | % |
Patient 3 | 900 mg | 44 | 28.3 | 15.0 | 16 | -47.0 | % |
Patient 4 | 600 mg | 34 | 12.6 | 3.3 | 21 | -73.8 | % |
Table 1: Reduction in liver fat content measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) |
“We had planned to enroll 120 patients in this study, which we thought would be sufficient to detect a 30 percent reduction in liver fat after 12 weeks,” continued
“Liver fat reductions achieved this quickly and of this magnitude are rarely seen ,” said Dr.
About the Phase 2 Trial
This double-blind, placebo-controlled Phase 2 study is designed to enroll 120 patients with presumed
About
Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the
Forward Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, the progress, enrollment, timing, design and results of our clinical trials; our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic; the availability of competing treatments; risks related to the development of miricorilant as a product candidate for
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Source: Corcept Therapeutics Incorporated