A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
- Conditions
- Antipsychotic-induced Weight Gain (AIWG)
- Interventions
- Drug: MiricorlilantDrug: Placebo
- Registration Number
- NCT04524403
- Lead Sponsor
- Corcept Therapeutics
- Brief Summary
This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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/m^2.
- Have a history of a medical condition affecting body weight (eg, 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 symptomatic hypotension
- Have a history of orthostatic hypotension
- Have a history of a seizure disorder.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Miricorlilant 600 mg Miricorlilant Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. Miricorlilant 900 mg Miricorlilant Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. Placebo Placebo Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Body Weight Baseline Day 1 and Week 26
- Secondary Outcome Measures
Name Time Method Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo Baseline Day 1 and Week 26 Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo Baseline Day 1 and Week 26 Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo Baseline Day 1 to Week 26 Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo
Trial Locations
- Locations (36)
Site # 240
🇺🇸Chicago, Illinois, United States
Site #166
🇺🇸Philadelphia, Pennsylvania, United States
Site #143
🇺🇸Bentonville, Arkansas, United States
Site #239
🇺🇸Garden Grove, California, United States
Site # 243
🇺🇸Glendale, California, United States
Site #224
🇺🇸Saint Louis, Missouri, United States
Site # 249
🇺🇸Little Rock, Arkansas, United States
Site #181
🇺🇸Raleigh, North Carolina, United States
Site #153
🇺🇸Culver City, California, United States
Site # 181
🇺🇸Raleigh, North Carolina, United States
Site #134
🇺🇸Lemon Grove, California, United States
Site #231
🇺🇸Staten Island, New York, United States
Site #163
🇺🇸Oceanside, California, United States
Site #140
🇺🇸Lincolnwood, Illinois, United States
Site #217
🇺🇸Lincoln, Nebraska, United States
Site #216
🇺🇸New York, New York, United States
Site # 247
🇺🇸Pico Rivera, California, United States
Site #202
🇺🇸Miami, Florida, United States
Site # 237
🇺🇸San Diego, California, United States
Site #151
🇺🇸Las Vegas, Nevada, United States
Site # 229
🇺🇸Rancho Cucamonga, California, United States
Site #144
🇺🇸North Miami, Florida, United States
Site # 150
🇺🇸Stanford, California, United States
Site # 245
🇺🇸New York, New York, United States
Site #241
🇺🇸Okeechobee, Florida, United States
Site # 244
🇺🇸Cedarhurst, New York, United States
Site #225
🇺🇸Flowood, Mississippi, United States
Site # 248
🇺🇸Charlotte, North Carolina, United States
Site #107
🇺🇸Dayton, Ohio, United States
Site # 230
🇺🇸North Canton, Ohio, United States
Site #165
🇺🇸Richardson, Texas, United States
Site #235
🇺🇸West Chester, Pennsylvania, United States
Site #206
🇺🇸DeSoto, Texas, United States
Site #066
🇺🇸Houston, Texas, United States
Site #137
🇺🇸Bellevue, Washington, United States
Site #223
🇺🇸Austin, Texas, United States