A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
NCT ID: NCT04524403
Last Updated: 2024-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2020-09-09
2022-08-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Miricorlilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant
Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
Miricorlilant 900 mg
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Miricorlilant
Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing
Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.
Placebo
Placebo for once-daily oral dosing
Interventions
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Miricorlilant
Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
Miricorlilant
Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing
Placebo
Placebo for once-daily oral dosing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Kavita Juneja, MD
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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Site #143
Bentonville, Arkansas, United States
Site # 249
Little Rock, Arkansas, United States
Site #153
Culver City, California, United States
Site #239
Garden Grove, California, United States
Site # 243
Glendale, California, United States
Site #134
Lemon Grove, California, United States
Site #163
Oceanside, California, United States
Site # 247
Pico Rivera, California, United States
Site # 229
Rancho Cucamonga, California, United States
Site # 237
San Diego, California, United States
Site # 150
Stanford, California, United States
Site #202
Miami, Florida, United States
Site #144
Miami Lakes, Florida, United States
Site #144
North Miami, Florida, United States
Site #241
Okeechobee, Florida, United States
Site # 240
Chicago, Illinois, United States
Site #140
Chicago, Illinois, United States
Site #140
Lincolnwood, Illinois, United States
Site #225
Flowood, Mississippi, United States
Site #224
St Louis, Missouri, United States
Site #217
Lincoln, Nebraska, United States
Site #151
Las Vegas, Nevada, United States
Site # 244
Cedarhurst, New York, United States
Site #216
New York, New York, United States
Site # 245
New York, New York, United States
Site #231
Staten Island, New York, United States
Site #231
Staten Island, New York, United States
Site # 248
Charlotte, North Carolina, United States
Site #181
Raleigh, North Carolina, United States
Site # 181
Raleigh, North Carolina, United States
Site #107
Dayton, Ohio, United States
Site # 230
North Canton, Ohio, United States
Site #166
Philadelphia, Pennsylvania, United States
Site #235
Thorndale, Pennsylvania, United States
Site #235
West Chester, Pennsylvania, United States
Site #223
Austin, Texas, United States
Site #206
DeSoto, Texas, United States
Site #066
Houston, Texas, United States
Site #165
Richardson, Texas, United States
Site #137
Bellevue, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CORT118335-877
Identifier Type: -
Identifier Source: org_study_id
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