A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 36
- 主要终点
- Change From Baseline in Body Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Miricorlilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
干预措施: Miricorlilant (Drug)
Miricorlilant 900 mg
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
干预措施: Miricorlilant (Drug)
Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Body Weight
时间窗: Baseline Day 1 and Week 26
次要结局
- 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)