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

Corcept Therapeutics71 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Antipsychotic-induced Weight Gain (AIWG)

Interventions

MiricorilantDRUG

Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing

PlaceboDRUG

Placebo tablets for once-daily oral dosing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (27)

Site 143

Bentonville, Arkansas, United States

Outcomes

Primary Outcomes

Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo

Time frame: Baseline Day 1 and Week 12

Number of Patients With One or More Treatment-emergent Adverse Events

Time frame: Up to Follow-up Visit (Week 16)

Number of Patients With One or More Treatment-emergent Serious Adverse Events

Time frame: 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

Time frame: Up to Follow-up Visit (up to Week 16)

Secondary Outcomes

Percentage of Patients Achieving More Than or Equal to 5% Weight Loss

Time frame: Baseline Day 1 to Week 12

Change From Baseline in HOMA-IR at 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.

Time frame: Baseline Day 1 and Week 12

Change From Baseline in Waist-to-hip Ratio at 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.

Time frame: Baseline Day 1 and Week 12

Data from ClinicalTrials.gov

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