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

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 and efficacy of miricorilant (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.

Study Overview

• Status: Completed
• Conditions: Antipsychotic-induced Weight Gain (AIWG)
• Intervention / Treatment: Drug: Miricorlilant; Drug: Miricorlilant; Drug: Miricorlilant

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.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 2

Contacts and Locations

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
    • North Miami, Florida, United States, 33161
      • Site #144
    • Okeechobee, Florida, United States, 34972
      • Site #241
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Site # 240
    • 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
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Site # 248
    • Raleigh, North Carolina, United States, 27610
      • Site # 181
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Site #107
    • North Canton, Ohio, United States, 44720
      • Site # 230
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • 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

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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/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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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; Drug: Miricorlilant; Miricorilant 900mg for oral dosing; Drug: Miricorlilant; Placebo 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 600mg for oral dosing; Drug: Miricorlilant; Miricorilant 900mg for oral dosing; Drug: Miricorlilant; Placebo 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; Miricorilant 600mg for oral dosing; Drug: Miricorlilant; Miricorilant 900mg for oral dosing; Drug: Miricorlilant; Placebo for oral dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in body weight	Baseline Day 1 to 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	Change from baseline in body weight for both 600 mg and 900 mg dose levels combined of miricorilant versus placebo	Baseline Day 1 to Week 26
Percentage of patients achieving a ≥5% weight loss for miricorilant versus placebo	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	Both dose levels versus placebo	Baseline Day 1 to Week 26

Collaborators and Investigators

• Sponsor: Corcept Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2020
• Primary Completion (ACTUAL): January 31, 2023
• Study Completion (ACTUAL): January 31, 2023

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): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Schizophrenia; Obesity; Risperidone; Paliperidone; Mental disorders; Weight Gain; Quetiapine; Olanzapine; Antipsychotic-induced weight gain (AIWG)
• Additional Relevant MeSH Terms: Mental Disorders; Body Weight; Schizophrenia Spectrum and Other Psychotic Disorders; Body Weight Changes; Schizophrenia; Weight Gain
• Other Study ID Numbers: CORT118335-877

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No