NCT07410507招募中2 期
A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-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
- 450
- 试验地点
- 135
- 主要终点
- Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²)
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 to placebo plus SoC for treatment of schizophrenia.
The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of schizophrenia
- •Are on a stable standard of care medication regimen for schizophrenia
- •If the duration of illness is >6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
- •Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
- •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 study intervention as directed,
- •maintain electronic or paper study diaries, as applicable, and
- •complete the required questionnaires
排除标准
- •Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
- •Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
- •Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
- •Are actively suicidal or deemed to be a significant risk for suicide
- •Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
研究组 & 干预措施
Brenipatide
Experimental
Brenipatide administered subcutaneously (SC) + SoC.
干预措施: Brenipatide (Drug)
Placebo
Placebo Comparator
Placebo administered SC + SoC.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²)
时间窗: Baseline, Week 52
次要结局
- Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36(Baseline, Week 36)
- Time to Relapse(Randomization up to Week 52)
- Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH)(Baseline, Week 52)
- Change from Baseline in Patient Global Impression - Severity(Baseline, Week 52)
- Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score(Baseline, Week 52)
- Change from Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Total Completion Time(Baseline, Week 52)
- Change from Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Total Score(Baseline, Week 52)
- Percentage of Participants with Body Mass Index ≥25 kg/m2 (BMI) Who Achieve Body Weight Reduction of ≥5%(Baseline up to 52 Weeks)
- Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide(Baseline up to Week 52)
- Number of Participants with Treatment-Emergent Anti-Drug Antibodies(Baseline up to Week 52)
研究者
研究点 (135)
Loading locations...
相似试验
招募中
2 期
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)Bipolar DisorderNCT07286175Eli Lilly and Company400
招募中
3 期
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)2025-522313-38-00Eli Lilly & Co.47
招募中
2 期
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid RelapseNCT07223840Eli Lilly and Company222
招募中
3 期
A Study of Brenipatide in Participants With Alcohol Use DisorderNCT07219953Eli Lilly and Company1,100
招募中
3 期
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use DisorderNCT07219966Eli Lilly and Company1,100