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.
- Conditions
- Antipsychotic-induced Weight Gain (AIWG)
- Interventions
- Drug: Placebo
- Registration Number
- NCT03818256
- Lead Sponsor
- Corcept Therapeutics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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 โฅ30 kg/m2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Miricorilant 600 mg Miricorilant Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks. Placebo Placebo Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method 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 Baseline Day 1 and Week 12 HOMA-IR = \[fasting plasma glucose (mg/dL) X fasting insulin (ยตU/mL)\]/405. HOMA-IR is a method to evaluate insulin sensitivity. The HOMA-IR score should be โค1.0 to be considered normal. A score \>1.9 indicates early insulin resistance and a score \>2.9 indicates significant insulin resistance.
Change From Baseline in Waist-to-hip Ratio at Week 12 Baseline Day 1 and 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.
Trial Locations
- Locations (24)
Site 239
๐บ๐ธGarden Grove, California, United States
Site 143
๐บ๐ธBentonville, Arkansas, United States
Site 249
๐บ๐ธLittle Rock, Arkansas, United States
Site 153
๐บ๐ธCulver City, California, United States
Site 134
๐บ๐ธLemon Grove, California, United States
Site 126
๐บ๐ธOakland, California, United States
Site 163
๐บ๐ธOceanside, California, United States
Site 229
๐บ๐ธRancho Cucamonga, California, United States
Site 202
๐บ๐ธMiami, Florida, United States
Site 144
๐บ๐ธNorth Miami, Florida, United States
Site 241
๐บ๐ธOkeechobee, Florida, United States
Site 140
๐บ๐ธLincolnwood, Illinois, United States
Site 146
๐บ๐ธWichita, Kansas, United States
Site 138
๐บ๐ธGlen Burnie, Maryland, United States
Site 151
๐บ๐ธLas Vegas, Nevada, United States
Site 216
๐บ๐ธNew York, New York, United States
Site 181
๐บ๐ธRaleigh, North Carolina, United States
Site 107
๐บ๐ธDayton, Ohio, United States
Site 235
๐บ๐ธWest Chester, Pennsylvania, United States
Site 206
๐บ๐ธDeSoto, Texas, United States
Site 066
๐บ๐ธHouston, Texas, United States
Site 165
๐บ๐ธRichardson, Texas, United States
Site 139
๐บ๐ธSalt Lake City, Utah, United States
Site 137
๐บ๐ธBellevue, Washington, United States