Corcept Therapeutics Completes Enrollment in Phase 2 GRATITUDE Study of Miricorilant in Patients with Antipsychotic-Induced Weight Gain
GRATITUDE is evaluating the efficacy, pharmacokinetics and safety of miricorilant among adult patients with schizophrenia or bipolar disorder and recent antipsychotic-induced weight gain. Patients were randomized 1:1 to receive either 600 milligrams of miricorilant or placebo each day, in addition to their established dose of antipsychotic medication, for 12 weeks.
Earlier this year, Corcept completed enrollment in a second study, GRATITUDE II, which is evaluating miricorilant as a treatment for long-standing antipsychotic-induced weight gain. In GRATITUDE II, patients with schizophrenia were randomized 1:1:1 to receive, in addition to their established dose of antipsychotic medication, either 600 milligrams or 900 milligrams of miricorilant or placebo each day for 26 weeks. Data from this study also will be available in the fourth quarter.
The primary endpoint in both GRATITUDE and GRATITUDE II is reduction in body weight compared to patients receiving placebo. Other important measures of metabolic activity will also be examined.
“Unfortunately, many of the most effective antipsychotics are also associated with significant weight gain, which poses an additional risk to the health of patients who are already suffering from schizophrenia and related disorders,” commented Dr.
Antipsychotic-Induced Weight Gain
Corcept’s clinical program seeks to build on positive data from earlier studies of cortisol modulation in healthy subjects. In 2020, Corcept completed a double-blind, placebo-controlled trial in which 96 healthy subjects received olanzapine and either 600 or 900 milligrams of miricorilant or placebo for 14 days. Subjects who received miricorilant gained significantly less weight than those who received placebo. These results were published in the
Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol and owns extensive
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 such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business, conduct our clinical trials and achieve our other goals during the COVID-19 pandemic; risks related to the development of miricorilant and other product candidates, including their clinical attributes, the availability of data in the timeframe anticipated, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our
Source: Corcept Therapeutics Incorporated