NCT07286175招募中2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 188
- 主要终点
- Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms.
The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II
- •Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as
- •self-inject study intervention
- •store and use the provided blinded study intervention, as directed
- •maintain electronic and paper study diaries, as applicable, and
- •complete the required questionnaires
- •Are on stable standard of care medication for bipolar disorder
排除标准
- •Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:
- •schizophrenia or other psychotic disorder
- •borderline personality disorder, or
- •any eating disorder
- •Have type 1 diabetes mellitus, or a history of
- •ketoacidosis, or
- •hyperosmolar state or coma
- •Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening
- •Are actively suicidal and or deemed to be at significant risk for suicide
- •Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo administered SC + SoC.
干预措施: Placebo (Drug)
Brenipatide Dose 2 .
Experimental
Brenipatide administered subcutaneous (SC) + SoC.
干预措施: Brenipatide (Drug)
Brenipatide Dose 1
Experimental
Brenipatide administered subcutaneous (SC) + SoC.
干预措施: Brenipatide (Drug)
结局指标
主要结局
Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion
时间窗: Randomization up to at least 6 months
次要结局
- Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2(Baseline, up to at least 6 months)
- Change from Baseline in Young Mania Rating Scale (YMRS) Total Score(Baseline, up to at least 6 months)
- Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score(Baseline, up to at least 6 months)
- Change from Baseline in Patient Rated Outcome as Measured by Patient's Global Impression of Severity (PGI-S)(Baseline, up to at least 6 months)
- Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score(Baseline, up to at least 6 months)
- Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score(Baseline, up to at least 6 months)
- Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2 and on an Atypical Antipsychotic(Baseline, up to at least 6 months)
- Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide(Baseline, up to at least 6 months)
- Number of Participants with Treatment-Emergent Anti-Drug Antibodies(Baseline, up to at least 6 months)
研究者
研究点 (188)
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