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Completed

NCT Number: NCT04524403

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

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.

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Key information

Conditions

Antipsychotic-induced Weight Gain (AIWG) Body Weight Body Weight Changes Mental 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 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.

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
  • 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.

Treatment and study plan

Miricorlilant

Drug

Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing

Other names: CORT118335

Placebo

Drug

Placebo for once-daily oral dosing

Primary outcomes

  1. Change From Baseline in Body Weight

    Time frame: Baseline Day 1 and Week 26

Secondary outcomes

  1. Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo

    Time frame: Baseline Day 1 and Week 26

  2. Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo

    Time frame: Baseline Day 1 to Week 26

    Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo

  3. Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo

    Time frame: Baseline Day 1 and Week 26

Other outcomes

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

    Time frame: Baseline Day 1 to Week 30

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

    Time frame: Baseline Day 1 to Week 30

  3. Number of Patients With One or More Treatment-emergent Adverse Events Leading to Study Drug Discontinuation

    Time frame: Baseline Day 1 to Week 30

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 in Obese Adult Patients With Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2020
Registry last updated
Jun 13, 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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