Back to resultsStudy Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
Primary Purpose
Antipsychotic-induced Weight Gain (AIWG)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Miricorlilant
Miricorlilant
Miricorlilant
Sponsored by
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, Paliperidone, Quetiapine, Olanzapine
Eligibility 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
Sites / Locations
- Site #143
- Site # 249
- Site #153
- Site #239
- Site # 243
- Site #134
- Site #163
- Site # 247
- Site # 229
- Site # 237
- Site # 150
- Site #202
- Site #144
- Site #241
- Site # 240
- Site #140
- Site #225
- Site #224
- Site #217
- Site #151
- Site # 244
- Site #216
- Site # 245
- Site #231
- Site # 248
- Site # 181
- Site #107
- Site # 230
- Site # 235
- Site #223
- Site #206
- Site #066
- Site #165
- Site #137
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Miricorlilant - 600 mg
Miricorlilant - 900 mg
Placebo
Arm Description
Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive 600 mg miricorilant once daily for 26 weeks.
Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive 900 mg miricorilant once daily for 26 weeks.
Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive placebo once daily for 26 weeks.
Outcomes
Primary Outcome Measures
Change from baseline in body weight
Secondary Outcome Measures
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
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
Change from baseline in waist-to-hip ratio for miricorilant versus placebo
Both dose levels versus placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04524403
Brief Title
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (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 (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.
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.
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, Paliperidone, Quetiapine, Olanzapine
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
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Miricorlilant - 600 mg
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive 600 mg miricorilant once daily for 26 weeks.
Arm Title
Miricorlilant - 900 mg
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive 900 mg miricorilant once daily for 26 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive placebo once daily for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Miricorlilant
Intervention Description
Miricorilant 600mg for oral dosing
Intervention Type
Drug
Intervention Name(s)
Miricorlilant
Intervention Description
Miricorilant 900mg for oral dosing
Intervention Type
Drug
Intervention Name(s)
Miricorlilant
Intervention Description
Placebo for oral dosing
Primary Outcome Measure Information:
Title
Change from baseline in body weight
Time Frame
Baseline Day 1 to Week 26
Secondary Outcome Measure Information:
Title
Change from baseline in body weight for both dose levels of miricorilant combined versus placebo
Description
Change from baseline in body weight for both 600 mg and 900 mg dose levels combined of miricorilant versus placebo
Time Frame
Baseline Day 1 to Week 26
Title
Percentage of patients achieving a ≥5% weight loss for miricorilant versus placebo
Description
Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo
Time Frame
Baseline Day 1 to Week 26
Title
Change from baseline in waist-to-hip ratio for miricorilant versus placebo
Description
Both dose levels versus placebo
Time Frame
Baseline Day 1 to Week 26
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
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
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 # 243
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Site #134
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Site #163
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Site # 247
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Site # 229
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Site # 237
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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 # 240
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Site #140
City
Lincolnwood
State/Province
Illinois
ZIP/Postal Code
60712
Country
United States
Facility Name
Site #225
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Site #224
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63125
Country
United States
Facility Name
Site #217
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Site #151
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Site # 244
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Site #216
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Site # 245
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Site #231
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Site # 248
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Site # 181
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Site #107
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Site # 230
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Site # 235
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Site #223
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
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 #137
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
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