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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.

Primary Purpose

Antipsychotic-induced Weight Gain (AIWG)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Miricorilant
Miricorilant
Sponsored by
Corcept Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antipsychotic-induced Weight Gain (AIWG) focused on measuring Antipsychotic-induced weight gain (AIWG), Obesity, Weight Gain, Mental disorders, Schizophrenia, Risperidone, Quetiapine, Olanzapine, Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 143
  • Site 249
  • Site 153
  • Site # 239
  • Site 134
  • Site 126
  • Site 163
  • Site 229
  • Site 150
  • Site 202
  • Site 144
  • Site 241
  • Site 140
  • Site 146
  • Site 138
  • Site 151
  • Site 216
  • Site 181
  • Site 107
  • Site 235
  • Site 206
  • Site 066
  • Site 165
  • Site 139
  • Site 137

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CORT118335- 600 mg

Placebo

Arm Description

Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive 600 mg miricorilant for 12 weeks.

Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive placebo for 12 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo
Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation

Secondary Outcome Measures

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
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
Change from baseline in waist-to-hip ratio at Week 12
600 mg Miricorilant versus placebo

Full Information

First Posted
January 24, 2019
Last Updated
February 6, 2023
Sponsor
Corcept Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03818256
Brief Title
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.
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 or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antipsychotic-induced Weight Gain (AIWG)
Keywords
Antipsychotic-induced weight gain (AIWG), Obesity, Weight Gain, Mental disorders, Schizophrenia, Risperidone, Quetiapine, Olanzapine, Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CORT118335- 600 mg
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive 600 mg miricorilant for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive placebo for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Miricorilant
Intervention Description
Miricorilant 600mg
Intervention Type
Drug
Intervention Name(s)
Miricorilant
Intervention Description
Placebo tablets for once daily oral dosing
Primary Outcome Measure Information:
Title
Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo
Time Frame
Baseline Day 1 to Week 12
Title
Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation
Time Frame
Up to Follow-up Visit (up to Week 16)
Secondary Outcome Measure Information:
Title
Percentage of patients achieving more than or equal to 5% weight loss
Description
Percentage of patients achieving more than or equal to 5% weight loss for 600 mg miricorilant versus placebo
Time Frame
Baseline Day 1 to week 12
Title
Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12
Description
Change in insulin resistance (HOMA-IR) for 600 mg miricorilant versus placebo
Time Frame
Baseline Day 1 to week 12
Title
Change from baseline in waist-to-hip ratio at Week 12
Description
600 mg Miricorilant versus placebo
Time Frame
Baseline Day1 to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kavita Juneja, MD
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Site 143
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Site 249
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Site 153
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Site # 239
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Site 134
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Site 126
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Site 163
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Site 229
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Site 150
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Site 202
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Site 144
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Site 241
City
Okeechobee
State/Province
Florida
ZIP/Postal Code
34972
Country
United States
Facility Name
Site 140
City
Lincolnwood
State/Province
Illinois
ZIP/Postal Code
60712
Country
United States
Facility Name
Site 146
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Site 138
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
20161
Country
United States
Facility Name
Site 151
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Site 216
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Site 181
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Site 107
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Site 235
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Site 206
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Site 066
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site 165
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Site 139
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States
Facility Name
Site 137
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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.

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