Business
Corcept Therapeutics Completes Enrollment in Phase 2 GRATITUDE Study of Miricorilant in Patients with Antipsychotic-Induced Weight Gain
Data to be Available in Fourth Quarter 2022 MENLO PARK, Calif., April 04, 2022 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a
About this update from Corcept Therapeutics Incorporated
[{"type":"text","content":"Data to be Available in Fourth Quarter 2022\nMENLO PARK, Calif., April 04, 2022 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in GRATITUDE – the company’s double-blind, placebo-controlled trial of its proprietary, selective cortisol modulator miricorilant as a potential treatment for patients with weight gain caused by antipsychotic medication use. Data will be available in the fourth quarter of this year. 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. Joshua Kantrowitz, who is leading the trial at New York State Psychiatric Institute and Columbia University Irving Medical Center. “The studies of miricorilant underway will provide important data to determine whether the weight gain and related adverse impact on cardiovascular and overall health associated with many antipsychotic medications can be mitigated.” Antipsychotic-Induced Weight Gain...