A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 24
- 主要终点
- Number of Patients With One or More Treatment-emergent Adverse Events
研究概览
简要总结
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.
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 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.
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 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 ≥30 kg/m2
排除标准
- •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
研究组 & 干预措施
Miricorilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
干预措施: Miricorilant (Drug)
Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients With One or More Treatment-emergent Adverse Events
时间窗: Up to Follow-up Visit (Week 16)
Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo
时间窗: Baseline Day 1 and Week 12
Number of Patients With One or More Treatment-emergent Serious Adverse Events
时间窗: 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
时间窗: Up to Follow-up Visit (up to Week 16)
次要结局
- 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)
- Change From Baseline in Waist-to-hip Ratio at Week 12(Baseline Day 1 and Week 12)