NCT07223840招募中2 期
A Phase 2, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for Reduction in Risk of Relapse to Cigarette Smoking in Adults (RENEW-Smk-1)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 222
- 试验地点
- 55
- 主要终点
- Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips
研究概览
简要总结
This study evaluates the efficacy and safety of brenipatide when compared to placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit.
Study participation will last approximately 34 weeks with up to 17 study visits, which includes a 2-week screening period, 24-week treatment period, 8-week safety follow-up period.
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, Care Provider)
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
- •Have recently quit smoking and are motivated to stay quit from smoking
- •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
排除标准
- •Have evidence of any substance use disorder within the past 180 days prior to screening, except mild alcohol use disorder, mild cannabis use disorder, or tobacco use disorder
- •Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the C-SSRS and the ideation occurred within the past 6 months, or have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 6 months
- •Have severe chronic obstructive pulmonary disease, or any other clinically severe respiratory condition that in the investigator's opinion may pose a risk.
- •Have participated in a clinical study and have 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
Brenipatide
Experimental
Brenipatide administered subcutaneously (SC).
干预措施: Brenipatide (Drug)
Placebo
Placebo Comparator
Placebo administered SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips
时间窗: Week 1 to Week 24
次要结局
- Number of Participants That Achieve CO-confirmed Continuous Abstinence from Cigarette Smoking Without Allowed Slips(Week 1 to Week 24)
- Mean Change from Baseline in Patient Reported Outcomes(Baseline, Week 24)
- Mean Percentage Change in Body Weight(Baseline, Week 24)
- Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide(Baseline up to Week 24)
- Number of Treatment-emergent Anit-drug Antibodies(Baseline up to Week 24)
研究者
研究点 (55)
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