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

May 21, 2024 updated by: Corcept Therapeutics

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, 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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Site #143
      • Little Rock, Arkansas, United States, 72211
        • Site # 249
    • California
      • Culver City, California, United States, 90230
        • Site #153
      • Garden Grove, California, United States, 92845
        • Site #239
      • Glendale, California, United States, 91206
        • Site # 243
      • Lemon Grove, California, United States, 91945
        • Site #134
      • Oceanside, California, United States, 92056
        • Site #163
      • Pico Rivera, California, United States, 90660
        • Site # 247
      • Rancho Cucamonga, California, United States, 91730
        • Site # 229
      • San Diego, California, United States, 92103
        • Site # 237
      • Stanford, California, United States, 94305
        • Site # 150
    • Florida
      • Miami, Florida, United States, 33122
        • Site #202
      • Miami Lakes, Florida, United States, 33016
        • Site #144
      • North Miami, Florida, United States, 33161
        • Site #144
      • Okeechobee, Florida, United States, 34972
        • Site #241
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Site # 240
      • Chicago, Illinois, United States, 60641
        • Site #140
      • Lincolnwood, Illinois, United States, 60712
        • Site #140
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Site #225
    • Missouri
      • Saint Louis, Missouri, United States, 63125
        • Site #224
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Site #217
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Site #151
    • New York
      • Cedarhurst, New York, United States, 11516
        • Site # 244
      • New York, New York, United States, 10032
        • Site #216
      • New York, New York, United States, 10036
        • Site # 245
      • Staten Island, New York, United States, 10312
        • Site #231
      • Staten Island, New York, United States, 10314
        • Site #231
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Site # 248
      • Raleigh, North Carolina, United States, 27610
        • Site # 181
      • Raleigh, North Carolina, United States, 27608
        • Site #181
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Site #107
      • North Canton, Ohio, United States, 44720
        • Site # 230
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19125
        • Site #166
      • Thorndale, Pennsylvania, United States, 19372
        • Site #235
      • West Chester, Pennsylvania, United States, 19380
        • Site #235
    • Texas
      • Austin, Texas, United States, 78754
        • Site #223
      • DeSoto, Texas, United States, 75115
        • Site #206
      • Houston, Texas, United States, 77030
        • Site #066
      • Richardson, Texas, United States, 75080
        • Site #165
    • Washington
      • Bellevue, Washington, United States, 98007
        • Site #137

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Miricorlilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Drug: Miricorlilant
Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
Other Names:
  • CORT118335
Drug: Miricorlilant
Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing
Other Names:
  • CORT118335
Experimental: Miricorlilant 900 mg
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Drug: Miricorlilant
Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
Other Names:
  • CORT118335
Drug: Miricorlilant
Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing
Other Names:
  • CORT118335
Placebo Comparator: Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.
Drug: Placebo
Placebo for once-daily oral dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Body Weight
Time Frame: Baseline Day 1 and Week 26
Baseline Day 1 and Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo
Time Frame: Baseline Day 1 and Week 26
Baseline Day 1 and Week 26
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
Baseline Day 1 to Week 26
Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo
Time Frame: Baseline Day 1 and Week 26
Baseline Day 1 and Week 26

Other Outcome Measures

Outcome Measure
Time Frame
Number of Patients With One or More Treatment-emergent Adverse Events
Time Frame: Baseline Day 1 to Week 30
Baseline Day 1 to Week 30
Number of Patients With One or More Treatment-emergent Serious Adverse Events
Time Frame: Baseline Day 1 to Week 30
Baseline Day 1 to Week 30
Number of Patients With One or More Treatment-emergent Adverse Events Leading to Study Drug Discontinuation
Time Frame: Baseline Day 1 to Week 30
Baseline Day 1 to Week 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcept Therapeutics

Investigators

  • Study Director: Kavita Juneja, MD, Corcept Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2020

Primary Completion (Actual)

July 29, 2022

Study Completion (Actual)

August 25, 2022

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 21, 2020

First Posted (Actual)

August 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORT118335-877

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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