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Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)

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ClinicalTrials.gov Identifier: NCT03818256
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Tracking Information
First Submitted Date  ICMJE January 24, 2019
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE October 31, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
  • Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo [ Time Frame: Baseline Day 1 to Week 12 ]
  • Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation [ Time Frame: Up to week 16 ]
  • Changes from baseline in hematology at Week 12 [ Time Frame: Baseline Day 1 to week 12 ]
  • Changes from baseline in chemistry panel at Week 12 [ Time Frame: Baseline Day 1 to week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Change from baseline in body weight at Week 12 for 600 mg CORT118335 versus placebo [ Time Frame: Baseline Day 1 to Week 12 ]
    Change from baseline in body weight at Week 12 for 600 mg CORT118335 versus placebo
  • Change from baseline in body weight at Week 12 for 200 mg CORT118335 versus placebo [ Time Frame: Baseline Day 1 to Week 12 ]
    Change from baseline in body weight at Week 12 for 200 mg CORT118335 versus placebo
  • Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation [ Time Frame: Up to week 16 ]
    Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation
  • Changes from baseline in hematology at Week 12 [ Time Frame: Baseline Day 1 to week 12 ]
    Changes from baseline in hematology at Week 12
  • Changes from baseline in chemistry panel at Week 12 [ Time Frame: Baseline Day 1 to week 12 ]
    Changes from baseline in chemistry panel at Week 12
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
  • Percentage of patients achieving more than or equal to 5% weight loss [ Time Frame: Baseline Day 1 to week 12 ]
    Percentage of patients achieving more than or equal to 5% weight loss for 600 mg miricorilant versus placebo
  • Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12 [ Time Frame: Baseline Day 1 to week 12 ]
    Change in insulin resistance (HOMA-IR) for 600 mg miricorilant versus placebo
  • Change from baseline in waist-to-hip ratio at Week 12 [ Time Frame: Baseline Day1 to week 12 ]
    600 mg Miricorilant versus placebo
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Percentage of patients achieving a ≥ 5% weight loss [ Time Frame: Baseline Day 1 to week 12 ]
    Percentage of patients achieving a ≥ 5% weight loss for:
    • 600 mg CORT118335 versus placebo
    • 200 mg CORT118335 versus placebo
    • 600 mg CORT118335 versus 200 mg CORT118335
    • CORT118335 (all active study drug) versus placebo
  • Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12 [ Time Frame: Baseline Day 1 to week 12 ]
    Change in insulin resistance (HOMA-IR) for:
    • 600 mg CORT118335 versus placebo
    • 200 mg CORT118335 versus placebo
    • 600 mg CORT118335 versus 200 mg CORT118335
    • CORT118335 (all active study drug) versus placebo
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: January 24, 2019)
  • Key PK parameters estimated from steady-state plasma concentrations [ Time Frame: Week 4 ]
    Cmax
  • Key PK parameters estimated from steady-state plasma concentrations [ Time Frame: Week 4 ]
    AUCtau
  • Key PK parameters estimated from steady-state plasma concentrations [ Time Frame: Week 4 ]
    Ctau
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
Brief Summary This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant in obese adult with schizophrenia treated with antipsychotic medications.
Detailed 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, or quetiapine.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Antipsychotic-induced Weight Gain (AIWG)
Intervention  ICMJE
  • Drug: Miricorilant
    Miricorilant 600mg
  • Drug: Miricorilant
    Placebo tablets for once daily oral dosing
Study Arms  ICMJE
  • Experimental: CORT118335- 600 mg
    Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive 600 mg miricorilant for 12 weeks.
    Intervention: Drug: Miricorilant
  • Placebo Comparator: Placebo
    Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive placebo for 12 weeks.
    Intervention: Drug: Miricorilant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
135
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of schizophrenia
  • Are currently taking olanzapine, risperidone, or quetiapine 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/m2

Exclusion Criteria:

  • Have a history of a medical condition affecting body weight (e.g., 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 hypotension
  • Have a history of orthostatic hypotension
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trial Lead 650-688-8806 study876ctgov@corcept.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03818256
Other Study ID Numbers  ICMJE CORT118335-876
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Corcept Therapeutics
Study Sponsor  ICMJE Corcept Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ada Lee, MD Corcept Therapeutics
PRS Account Corcept Therapeutics
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP