Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 50 for:    Corcept Therapeutics

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04524403
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : December 23, 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 (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.

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

Detailed Description:

This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and pharmacokinetics (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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 in Obese Adult Patients With Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Miricorlilant - 600 mg
Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive 600 mg miricorilant once daily for 26 weeks.
Drug: Miricorlilant
Miricorilant 600mg for oral dosing

Experimental: Miricorlilant - 900 mg
Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive 900 mg miricorilant once daily for 26 weeks.
Drug: Miricorlilant
Miricorilant 900mg for oral dosing

Placebo Comparator: Placebo
Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive placebo once daily for 26 weeks.
Drug: Miricorlilant
Placebo for oral dosing




Primary Outcome Measures :
  1. Change from baseline in body weight [ Time Frame: Baseline Day 1 to Week 26 ]

Secondary Outcome Measures :
  1. Change from baseline in body weight for both dose levels of miricorilant combined versus placebo [ Time Frame: Baseline Day 1 to Week 26 ]
    Change from baseline in body weight for both 600 mg and 900 mg dose levels combined of miricorilant versus placebo

  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 to Week 26 ]
    Both dose levels versus placebo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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, 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/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
  • Have a history of a seizure disorder

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): NCT04524403


Contacts
Layout table for location contacts
Contact: Clinical Trial Lead 650-688-8806 Corceptstudy877ct.gov@corcept.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Layout table for investigator information
Study Director: Ada Lee, MD Corcept Therapeutics
Layout table for additonal information
Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT04524403    
Other Study ID Numbers: CORT118335-877
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020

Layout table for additional information
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
Paliperidone
Quetiapine
Olanzapine
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Gain
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight Changes
Body Weight