Corcept Therapeutics Incorporated (NASDAQ:CORT) has enrolled the first subject in its GRATITUDE II Phase 2 double-blind, randomized, placebo-controlled study of miricorilant in obese patients who have schizophrenia and antipsychotic-induced weight gain.
Cocerpt Therapeutics targeting enrolment of 150 patients in GRATITUDE II trial
The GRATITUDE II trial will enroll around 150 patients expected to continue receiving their established antipsychotic medication doses. On the other hand, they will also receive either 600 mg of miricorilant or 900 mg of miricorilant or placebo for 26 weeks. The study will be conducted across 35 centers in the US, and the primary endpoint is achieving bodyweight reduction in patients using antipsychotic medication.
In the first Phase, 2 study (GRATITUDE I) of miricorilant in antipsychotic-induced weight gains, the company has continued to enroll more schizophrenic patients and recent weight gains. The subjects in GRATITUDE I have been receiving 600 mg of miricorilant and their antipsychotic regiment or placebo for two weeks. The trial’s primary endpoint is to realize a change in bodyweight in the subjects.
Miricorilant showing promise in weight gain reduction
The company’s Chief Medical Officer Andreas Grauer stated that significant, sustained body weight gain related to metabolic co-morbidities tends to shorten the lives of millions of patients taking antipsychotic medication. Equally, the gain in body weight can substantially reduce the quality of life in some other patients. Andreas explained that miricorilant has shown huge potential as a treatment of the disorder. He further indicated that after two weeks in the double-blind placebo-controlled Phase 1b study, healthy subjects that received miricorilant plus olanzapine showed significantly less weight gain than the placebo group received only olanzapine.
Also, results indicated that patients that received miricorilant had a much smaller increase in AST and ALT enzymes suggesting that miricorilant can protect the liver. Andreas said that they are optimistic about extending and confirming the next Phase 1b results of the GRATITUDE II trial that is currently using enhanced miricorilant formulation over a longer period of treatment.