NCT04524403.

Study name	Study evaluating the safety, efficacy, and pharmacokinetics of miricorilant in obese adult patients with schizophrenia while taking antipsychotic medications (GRATITUDE II)
Methods	Phase 2, double‐blind, placebo‐controlled, randomised study
Participants	Inclusion criteria Have a diagnosis of schizophrenia Are currently taking olanzapine, risperidone, paliperidone, or quetiapine and have gained weight from treatment while on these medications Must be on a stable dose of medication for 1 month prior to screening Have a BMI ≥30 kg/m2 Exclusion criteria Have a history of a medical condition affecting body weight (e.g. poorly controlled hyper‐ or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome) Have poorly controlled diabetes mellitus Have poorly controlled hypertension Have a history of hypotension Have a history of orthostatic hypotension Have a history of a seizure disorder
Interventions	Experimental: miricorilant ‐ 600 mg once/d for 26 weeks Experimental: miricorilant ‐ 900 mg once/d for 26 weeks Placebo comparator: placebo once/d for 26 weeks
Outcomes	Primary outcomes Change from baseline in body weight Secondary outcomes Change from baseline in body weight for both dose levels of miricorilant combined versus placebo Percentage of participants achieving a ≥ 5% weight loss for miricorilant versus placebo Change from baseline in waist‐to‐hip ratio for miricorilant versus placebo
Starting date	24 August 2020
Contact information	Study Director: Ada Lee, MD, Corcept Therapeutics Contact: Clinical Trial Lead 650‐327‐3270 study877ct.gov@corcept.com
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