Corcept Therapeutics Initiates Second Phase 2 Trial of Miricorilant to Treat Weight Gain Caused by Antipsychotic Medication
September 10 2020 - 8:30AM
Corcept Therapeutics Incorporated (NASDAQ: CORT), 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 cortisol, today announced
enrollment of its first patient in GRATITUDE II, a randomized,
double-blind, placebo-controlled, Phase 2 trial of miricorilant in
obese patients with schizophrenia and long-standing
antipsychotic-induced weight gain (APIWG).
GRATITUDE II has a planned enrollment of 150
patients, who will continue to receive their established dose of
antipsychotic medication, plus either 600 milligrams of
miricorilant, 900 milligrams of miricorilant or placebo, for 26
weeks. The primary endpoint is reduction in bodyweight. GRATITUDE
II will be conducted at 35 centers in the United States.
GRATITUDE I, Corcept’s first Phase 2 trial of
miricorilant in APIWG, continues to enroll patients with
schizophrenia and recent weight gain. Patients in GRATITUDE I
receive, in addition to their established antipsychotic regimen,
either 600 milligrams of miricorilant or placebo for 12 weeks. The
primary endpoint is change in bodyweight.
“Substantial, sustained weight gain and
associated metabolic co-morbidities shorten the lives of many of
the millions of patients who take antipsychotic medications and
significantly reduce quality of life for many more,” said Andreas
Grauer, MD, Corcept’s Chief Medical Officer. “Miricorilant has
demonstrated promise as a potential treatment for this
disorder.1 In our double-blind, placebo-controlled, Phase 1b
trial, after just two weeks of treatment, healthy subjects given
miricorilant in addition to olanzapine gained significantly less
weight than subjects who received olanzapine plus placebo. Patients
receiving miricorilant also experienced smaller increases in the
enzymes AST and ALT, which suggests miricorilant may help protect
the liver. We hope to confirm and extend our Phase 1b results in
GRATITUDE II, which is using an improved formulation of
miricorilant and a longer treatment duration.”
About Corcept Therapeutics
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 hormone cortisol. Korlym® was the first drug approved by the
U.S. Food and Drug Administration for patients with Cushing’s
syndrome. Corcept has discovered a large portfolio of proprietary
compounds that selectively modulate the effects of cortisol. The
company owns extensive United States and foreign intellectual
property covering the composition of its selective cortisol
modulators and the use of cortisol modulators to treat a variety of
serious disorders.
CONTACT:Christopher S. James, MDDirector,
Investor RelationsCorcept
Therapeutics650-684-8725cjames@corcept.comwww.corcept.com
1 For data from our studies in animal models of
APIWG, see our 2020 American Psychiatry Association (APA) poster at
the Research & Pipeline / Publications tab of our website.
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