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) (J2S-MC-GZMO)

未提供0 个研究点目标入组 222 人开始时间: 待定

适应症

试验速览

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•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

•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

发起方

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