A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications
NCT ID: NCT03818256
Last Updated: 2024-09-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
71 participants
INTERVENTIONAL
2019-12-04
2022-07-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
NCT04524403
A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia
NCT05542264
The Effect of CORT118335 on Olanzapine-Induced Weight Gain
NCT03877562
Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
NCT00095524
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
NCT04072354
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Miricorilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant
Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo
Placebo tablets for once-daily oral dosing
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Miricorilant
Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
Placebo
Placebo tablets for once-daily oral dosing
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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/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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Corcept Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kavita Juneja, MD
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 134
Lemon Grove, California, United States
Site 126
Oakland, California, United States
Site 163
Oceanside, California, United States
Site 229
Rancho Cucamonga, California, United States
Site 202
Miami, Florida, United States
Site 144
North Miami, Florida, United States
Site 241
Okeechobee, Florida, United States
Site 140
Chicago, Illinois, United States
Site 140
Lincolnwood, Illinois, United States
Site 146
Wichita, Kansas, United States
Site 138
Glen Burnie, Maryland, United States
Site 151
Las Vegas, Nevada, United States
Site 216
New York, New York, United States
Site 181
Raleigh, North Carolina, United States
Site 181
Raleigh, North Carolina, United States
Site 107
Dayton, Ohio, United States
Site 235
Thorndale, Pennsylvania, United States
Site 235
West Chester, Pennsylvania, United States
Site 206
DeSoto, Texas, United States
Site 066
Houston, Texas, United States
Site 165
Richardson, Texas, United States
Site 139
Salt Lake City, Utah, United States
Site 137
Bellevue, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CORT118335-876
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.