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NCT Number: NCT03818256

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 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.

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Key information

Conditions

Antipsychotic-induced Weight Gain (AIWG) Bipolar Disorder Bipolar and Related Disorders Body Weight Body Weight Changes Mental Disorders Mood Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Weight Gain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 143, Bentonville, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Miricorilant

Drug

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

Other names: CORT118335

Placebo

Drug

Placebo tablets for once-daily oral dosing

Primary outcomes

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

    Time frame: Baseline Day 1 and Week 12

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

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

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

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

  4. 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

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

    Time frame: Baseline Day 1 to Week 12

  2. Change From Baseline in HOMA-IR at Week 12

    Time frame: 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.

  3. Change From Baseline in Waist-to-hip Ratio at Week 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)

Acronym: GRATITUDE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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