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

Corcept Therapeutics

Status and phase: Completed; Phase 2

Conditions: Antipsychotic-induced Weight Gain (AIWG)

Treatments: Drug: Miricorilant; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03818256

CORT118335-876

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 adults with schizophrenia or bipolar disorder 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 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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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71 participants in 2 patient groups, including a placebo group

Miricorilant 600 mg

Experimental group

Description:

Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.

Treatment:

Drug: Miricorilant

Placebo

Placebo Comparator group

Description:

Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.

Treatment:

Drug: Placebo