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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

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.

Condition or disease Intervention/treatment Phase
Antipsychotic-induced Weight Gain (AIWG) Drug: Miricorilant Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official 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 and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Miricorilant
Miricorilant 600mg

Placebo Comparator: Placebo
Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive placebo for 12 weeks.
Drug: Miricorilant
Placebo tablets for once daily oral dosing




Primary Outcome Measures :
  1. Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo [ Time Frame: Baseline Day 1 to Week 12 ]
  2. Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation [ Time Frame: Up to week 16 ]
  3. Changes from baseline in hematology at Week 12 [ Time Frame: Baseline Day 1 to week 12 ]
  4. Changes from baseline in chemistry panel at Week 12 [ Time Frame: Baseline Day 1 to week 12 ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change from baseline in waist-to-hip ratio at Week 12 [ Time Frame: Baseline Day1 to week 12 ]
    600 mg Miricorilant versus placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818256


Contacts
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Contact: Clinical Trial Lead 650-688-8806 study876ctgov@corcept.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Ada Lee, MD Corcept Therapeutics

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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT03818256    
Other Study ID Numbers: CORT118335-876
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corcept Therapeutics:
Antipsychotic-induced weight gain (AIWG)
Obesity
Weight Gain
Mental disorders
Schizophrenia
Risperidone
Quetiapine
Olanzapine
Additional relevant MeSH terms:
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Body Weight
Weight Gain
Schizophrenia
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight Changes
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs