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

Corcept Therapeutics

Status and phase: Completed; Phase 2

Conditions: Antipsychotic-induced Weight Gain (AIWG)

Treatments: Drug: Miricorlilant; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04524403

CORT118335-877

Details and patient eligibility

About

This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.

Full description

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

Miricorlilant 600 mg

Experimental group

Description:

Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.

Treatment:

Drug: Miricorlilant

Drug: Miricorlilant

Miricorlilant 900 mg

Experimental group

Description:

Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.

Treatment:

Drug: Miricorlilant

Drug: Miricorlilant

Placebo

Placebo Comparator group

Description:

Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.

Treatment:

Drug: Placebo