A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)

This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and PK of miricorilant in obese patients with schizophrenia who are currently taking olanzapine, risperidone, paliperidone, or quetiapine.

Patients who meet the criteria for the Study CORT118335-877 will be randomized on Day 1 to receive 600 mg miricorilant, 900 mg miricorilant, or placebo for 26 weeks.

• Miricorlilant (Drug), also known as CORT118335: Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
• Miricorlilant (Drug), also known as CORT118335: Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing
• Placebo (Drug): Placebo for once-daily oral dosing

Primary outcomes

• Change From Baseline in Body Weight [Baseline Day 1 and Week 26]

Secondary outcomes

• Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo [Baseline Day 1 and Week 26]
• Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo [Baseline Day 1 to Week 26]: Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo
• Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo [Baseline Day 1 and Week 26]

Other outcomes

• Number of Patients With One or More Treatment-emergent Adverse Events [Baseline Day 1 to Week 30]
• Number of Patients With One or More Treatment-emergent Serious Adverse Events [Baseline Day 1 to Week 30]
• Number of Patients With One or More Treatment-emergent Adverse Events Leading to Study Drug Discontinuation [Baseline Day 1 to Week 30]

Sex: All, ages: 18 Years to 65 Years

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/m\^2.

Exclusion Criteria:

* Have a history of a medical condition affecting body weight (eg, 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 symptomatic hypotension
* Have a history of orthostatic hypotension
* Have a history of a seizure disorder.

Participant flow

Outcome results

• Change From Baseline in Body Weight (Primary), Least squares mean, kg: Miricorlilant 600 mg -1.41 +/- 0.644; Miricorlilant 900 mg -0.91 +/- 0.631; Placebo -1.66 +/- 0.644 (p 0.7870)
• Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo (Secondary), Least squares mean, kg: Miricorilant 600 mg or 900 mg -1.16 +/- 0.454; Placebo -1.65 +/- 0.642 (p 0.5228)
• Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo (Secondary), Count of participants, Participants: Miricorlilant 600 mg 12; Miricorlilant 900 mg 7; Placebo 8 (p 0.2537)
• Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo (Secondary), Least squares mean, Ratio: Miricorlilant 600 mg 0.002 +/- 0.0077; Miricorlilant 900 mg 0.009 +/- 0.0075; Placebo 0.002 +/- 0.0077 (p 0.9870)
• Number of Patients With One or More Treatment-emergent Adverse Events (Other pre specified), Count of participants, Participants: Miricorlilant 600 mg 26; Miricorlilant 900 mg 21; Placebo 21
• Number of Patients With One or More Treatment-emergent Serious Adverse Events (Other pre specified), Count of participants, Participants: Miricorlilant 600 mg 1; Miricorlilant 900 mg 2; Placebo 2
• Number of Patients With One or More Treatment-emergent Adverse Events Leading to Study Drug Discontinuation (Other pre specified), Count of participants, Participants: Miricorlilant 600 mg 7; Miricorlilant 900 mg 5; Placebo 4

Adverse events

Time frame: Baseline Day 1 to Week 30

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2022-06-09)
• Statistical Analysis Plan (PDF, 2022-10-13)

• Kavita Juneja, MD, Study director, Corcept Therapeutics