A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Brenipatide, Placebo.
- Кому может быть актуально
- Состояния в реестре: Smoking. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Китай, Япония
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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)
Обзор
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.
Вмешательства
- Препарат Brenipatide
Administered SC - Препарат Placebo
Administered SC
Первичные конечные точки
- Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips [Срок оценки: Week 1 to Week 24]
Вторичные конечные точки (5)
- Number of Participants That Achieve CO-confirmed Continuous Abstinence from Cigarette Smoking Without Allowed Slips [Срок оценки: Week 1 to Week 24]
- Mean Change from Baseline in Patient Reported Outcomes [Срок оценки: Baseline, Week 24]
- Mean Percentage Change in Body Weight [Срок оценки: Baseline, Week 24]
- Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Срок оценки: Baseline up to Week 24]
- Number of Treatment-emergent Anit-drug Antibodies [Срок оценки: Baseline up to Week 24]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 17 центров
- Woodland Research Northwest — Rogers
- Hillcrest Medical Research — DeLand
- TecTum Research — Hollywood
- K2 Medical Research ORLANDO — Maitland
- GTL Medical & Research Group — Miami
- North Georgia Clinical Research — Woodstock
- Revival Research Institute, LLC — Dearborn
- Arch Clinical Trials — St Louis
- … и ещё 9 центров
Китай · 8 центров
- Beijing Chaoyang Hospital, Capital Medical University — Пекин
- Beijing Anding Hospital - Affiliated Capital University of Medical Science — Пекин
- Sichuan Provincial People's Hospital — Чэнду
- 2nd Affiliated Hospital Chongqing Medical University — Чунцин
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine — Ханчжоу
- Taizhou Hospital of Zhejiang Province — Linhai
- The first affiliated hospital of Ningbo university — Ningbo
- The University of Hong Kong-Shenzhen Hospital — Шэньчжэнь
Япония · 3 центра
- Miyazaki RC Clinic — Shinagawa-ku
- Samoncho Clinic — Shinjuku
- Higashi Shinjuku Clinic — Tokyo
Идентификаторы
NCT: NCT07223840 · 27411 · J2S-MC-GZMO