A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications

This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and PK of miricorilant in obese patients with schizophrenia or bipolar disorder who are currently taking oral or injectable atypical antipsychotic medication.

Patients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to receive 600 mg miricorilant or placebo for 12 weeks.

• Miricorilant (Drug), also known as CORT118335: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
• Placebo (Drug): Placebo tablets for once-daily oral dosing

Primary outcomes

• Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo [Baseline Day 1 and Week 12]
• Number of Patients With One or More Treatment-emergent Adverse Events [Up to Follow-up Visit (Week 16)]
• Number of Patients With One or More Treatment-emergent Serious Adverse Events [Up to Follow-up Visit (up to Week 16)]
• Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation [Up to Follow-up Visit (up to Week 16)]

Secondary outcomes

• Percentage of Patients Achieving More Than or Equal to 5% Weight Loss [Baseline Day 1 to Week 12]
• Change From Baseline in HOMA-IR at Week 12 [Baseline Day 1 and Week 12]: HOMA-IR = \[fasting plasma glucose (mg/dL) X fasting insulin (µU/mL)\]/405. HOMA-IR is a method to evaluate insulin sensitivity. The HOMA-IR score should be ≤1.0 to be considered normal. A score >1.9 indicates early insulin resistance and a score >2.9 indicates significant insulin resistance.
• Change From Baseline in Waist-to-hip Ratio at Week 12 [Baseline Day 1 and Week 12]: Waist-to-hip ratio compares the circumference of the waist to the circumference of the hips. The ratio is calculated by dividing the waist measurement by the hip measurement, using the same units of measurement for both. A waist-to-hip ratio <0.95 in men and <0.80 in women is considered healthy.

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Have a diagnosis of schizophrenia or bipolar disorder
* Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications
* Must be on a stable dose of medication for 1 month prior to Screening
* Are able to successfully complete placebo tablet swallow test
* 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.

Participant flow

Outcome results

• Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo (Primary), Least squares mean, kg: Miricorilant 600 mg -0.98 +/- 0.414; Placebo -1.08 +/- 0.415 (p 0.8511)
• Number of Patients With One or More Treatment-emergent Adverse Events (Primary), Count of participants, Participants: Miricorilant 600 mg 16; Placebo 18
• Number of Patients With One or More Treatment-emergent Serious Adverse Events (Primary), Count of participants, Participants: Miricorilant 600 mg 1; Placebo 1
• Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation (Primary), Count of participants, Participants: Miricorilant 600 mg 3; Placebo 1
• Percentage of Patients Achieving More Than or Equal to 5% Weight Loss (Secondary), Count of participants, Participants: Miricorilant 600 mg 2; Placebo 3 (p 0.8169)
• Change From Baseline in HOMA-IR at Week 12 (Secondary), Median, HOMA-IR score: Miricorilant 600 mg 1.080 (-2.020 to 3.780); Placebo 0.890 (-0.970 to 2.400) (p 0.9285)
• Change From Baseline in Waist-to-hip Ratio at Week 12 (Secondary), Least squares mean, Ratio: Miricorilant 600 mg 0.008 +/- 0.0092; Placebo 0.001 +/- 0.0091 (p 0.5669)

Adverse events

Time frame: Baseline Day 1 to Week 16

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2022-01-11)
• Statistical Analysis Plan (PDF, 2022-07-27)

• Kavita Juneja, MD, Study director, Corcept Therapeutics