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This phase 2, double blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese adults with schizophrenia or bipolar disorder treated with antipsychotic medications.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miricorilant 600 mg | Experimental | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks. |
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| Placebo | Placebo Comparator | Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miricorilant | Drug | Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo | Baseline Day 1 and Week 12 | |
| Number of Patients With One or More Treatment-emergent Adverse Events | Up to Follow-up Visit (Week 16) | |
| Number of Patients With One or More Treatment-emergent Serious Adverse Events | Up to Follow-up Visit (up to Week 16) | |
| Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation | Up to Follow-up Visit (up to Week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving More Than or Equal to 5% Weight Loss | Baseline Day 1 to Week 12 | |
| Change From Baseline in HOMA-IR at Week 12 | HOMA-IR = [fasting plasma glucose (mg/dL) X fasting insulin (µU/mL)]/405. HOMA-IR is a method to evaluate insulin sensitivity. The HOMA-IR score should be ≤1.0 to be considered normal. A score >1.9 indicates early insulin resistance and a score >2.9 indicates significant insulin resistance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kavita Juneja, MD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 143 | Bentonville | Arkansas | 72712 | United States | ||
| Site 249 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2022 | May 21, 2024 |
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Double Blind
| Placebo | Drug | Placebo tablets for once-daily oral dosing |
|
| Baseline Day 1 and Week 12 |
| Change From Baseline in Waist-to-hip Ratio at Week 12 | Waist-to-hip ratio compares the circumference of the waist to the circumference of the hips. The ratio is calculated by dividing the waist measurement by the hip measurement, using the same units of measurement for both. A waist-to-hip ratio <0.95 in men and <0.80 in women is considered healthy. | Baseline Day 1 and Week 12 |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Site 153 | Culver City | California | 90230 | United States |
| Site 239 | Garden Grove | California | 92845 | United States |
| Site 134 | Lemon Grove | California | 91945 | United States |
| Site 126 | Oakland | California | 94607 | United States |
| Site 163 | Oceanside | California | 92056 | United States |
| Site 229 | Rancho Cucamonga | California | 91730 | United States |
| Site 202 | Miami | Florida | 33122 | United States |
| Site 144 | North Miami | Florida | 33161 | United States |
| Site 241 | Okeechobee | Florida | 34972 | United States |
| Site 140 | Chicago | Illinois | 60641 | United States |
| Site 140 | Lincolnwood | Illinois | 60712 | United States |
| Site 146 | Wichita | Kansas | 67214 | United States |
| Site 138 | Glen Burnie | Maryland | 20161 | United States |
| Site 151 | Las Vegas | Nevada | 89102 | United States |
| Site 216 | New York | New York | 10032 | United States |
| Site 181 | Raleigh | North Carolina | 27608 | United States |
| Site 181 | Raleigh | North Carolina | 27610 | United States |
| Site 107 | Dayton | Ohio | 45417 | United States |
| Site 235 | Thorndale | Pennsylvania | 19372 | United States |
| Site 235 | West Chester | Pennsylvania | 19380 | United States |
| Site 206 | DeSoto | Texas | 75115 | United States |
| Site 066 | Houston | Texas | 77030 | United States |
| Site 165 | Richardson | Texas | 75080 | United States |
| Site 139 | Salt Lake City | Utah | 84105 | United States |
| Site 137 | Bellevue | Washington | 98007 | United States |
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
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| NOT COMPLETED |
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All enrolled patients
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo | Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks. Placebo: Placebo tablets for once daily oral dosing |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body weight | Mean | Standard Deviation | kg |
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| Homeostatic model assessment for insulin resistance (HOMA-IR) | HOMA-IR = [fasting plasma glucose (mg/dL) X fasting insulin (µU/mL)]/405. HOMA-IR is a method to evaluate insulin sensitivity. The HOMA-IR score should be ≤1.0 to be considered normal. A score >1.9 indicates early insulin resistance and a score >2.9 indicates significant insulin resistance. | Two patients in the placebo group did not have a Baseline HOMA-IR measurement. | Mean | Standard Deviation | HOMA-IR score |
| |||||||||||||
| Waist-to-hip ratio | Waist-to-hip ratio compares the circumference of the waist to the circumference of the hips. The ratio is calculated by dividing the waist measurement by the hip measurement, using the same units of measurement for both. A waist-to-hip ratio <0.95 in men and <0.80 in women is considered healthy. | Mean | Standard Deviation | Ratio |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo | The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had body weight assessed at Baseline and on Week 12. | Posted | Least Squares Mean | Standard Error | kg | Baseline Day 1 and Week 12 |
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| Primary | Number of Patients With One or More Treatment-emergent Adverse Events | The Safety Population included patients who received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Up to Follow-up Visit (Week 16) |
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| Primary | Number of Patients With One or More Treatment-emergent Serious Adverse Events | The Safety Population included patients who received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Up to Follow-up Visit (up to Week 16) |
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| Primary | Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation | The Safety Population included patients who received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Up to Follow-up Visit (up to Week 16) |
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| Secondary | Percentage of Patients Achieving More Than or Equal to 5% Weight Loss | The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had baseline and ≥1 body weight measurement taken on or after Week 4. | Posted | Count of Participants | Participants | Baseline Day 1 to Week 12 |
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| Secondary | Change From Baseline in HOMA-IR at Week 12 | HOMA-IR = [fasting plasma glucose (mg/dL) X fasting insulin (µU/mL)]/405. HOMA-IR is a method to evaluate insulin sensitivity. The HOMA-IR score should be ≤1.0 to be considered normal. A score >1.9 indicates early insulin resistance and a score >2.9 indicates significant insulin resistance. | The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had HOMA-IR assessed at Baseline and on Week 12. | Posted | Median | Inter-Quartile Range | HOMA-IR score | Baseline Day 1 and Week 12 |
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| Secondary | Change From Baseline in Waist-to-hip Ratio at Week 12 | Waist-to-hip ratio compares the circumference of the waist to the circumference of the hips. The ratio is calculated by dividing the waist measurement by the hip measurement, using the same units of measurement for both. A waist-to-hip ratio <0.95 in men and <0.80 in women is considered healthy. | The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had hip and waist measurements at Baseline and on Week 12. | Posted | Least Squares Mean | Standard Error | Ratio | Baseline Day 1 and Week 12 |
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Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 35 | 1 | 35 | 12 | 35 |
| EG001 | Placebo | Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks. Placebo: Placebo tablets for once daily oral dosing | 0 | 36 | 1 | 36 | 5 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperthermia malignant | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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No individual publications will be allowed before publication of the multicenter results except as agreed with Corcept. The Investigator agrees to submit all manuscripts or abstracts to Corcept for review before submission to the publisher.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Corcept Therapeutics Incorporated | 650-327-3270 | info@corcept.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2022 | May 21, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015430 | Weight Gain |
| D001523 | Mental Disorders |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| C000606526 | CORT118335 |
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