This Phase 2, Double Blind, Placebo-controlled, Randomized Study is to Assess the Safety and Efficacy of Miricorilant in Obese Adult With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)

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.

Study Overview

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

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 or bipolar disorder who are currently taking oral or injectable atypical antipsychotic medication.

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: Interventional
• Enrollment (Actual): 71
• 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
    • Lemon Grove, California, United States, 91945
      • Site 134
    • Oakland, California, United States, 94607
      • Site 126
    • Oceanside, California, United States, 92056
      • Site 163
    • Rancho Cucamonga, California, United States, 91730
      • Site 229
    • 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
    • Lincolnwood, Illinois, United States, 60712
      • Site 140
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Site 146
  • Maryland
    • Glen Burnie, Maryland, United States, 20161
      • Site 138
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Site 151
  • New York
    • New York, New York, United States, 10032
      • Site 216
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Site 181
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Site 107
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Site 235
  • Texas
    • DeSoto, Texas, United States, 75115
      • Site 206
    • Houston, Texas, United States, 77030
      • Site 066
    • Richardson, Texas, United States, 75080
      • Site 165
  • Utah
    • Salt Lake City, Utah, United States, 84105
      • Site 139
  • 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 or bipolar disorder
• Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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; Drug: Miricorilant; Placebo tablets for once daily oral dosing
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; Miricorilant 600mg; Drug: Miricorilant; Placebo tablets for once daily oral dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo	Baseline Day 1 to Week 12
Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation	Up to Follow-up Visit (up to Week 16)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving more than or equal to 5% weight loss	Percentage of patients achieving more than or equal to 5% weight loss for 600 mg miricorilant versus placebo	Baseline Day 1 to week 12
Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12	Change in insulin resistance (HOMA-IR) for 600 mg miricorilant versus placebo	Baseline Day 1 to week 12
Change from baseline in waist-to-hip ratio at Week 12	600 mg Miricorilant versus placebo	Baseline Day1 to week 12

Collaborators and Investigators

• Sponsor: Corcept Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2019
• Primary Completion (ACTUAL): December 31, 2022
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (ACTUAL): January 28, 2019

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; Bipolar Disorder; Risperidone; 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; Bipolar and Related Disorders; Schizophrenia; Bipolar Disorder; Weight Gain
• Other Study ID Numbers: CORT118335-876

Drug and device information, study documents

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