Идёт набор NCT07571109
AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea
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: NNC0487-0111, Placebo (matched to NNC0487-0111).
- Кому может быть актуально
- Состояния в реестре: Obesity, Overweight, Obstructive Sleep Apnoea. Базовые параметры: от 18 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, Австралия, Китай, Германия, Индия +5
- 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
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Treated With Positive Airway Pressure (AMAZE 4)
Обзор
This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.
Вмешательства
- Препарат NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. - Препарат Placebo (matched to NNC0487-0111)
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Первичные конечные точки
- Relative change in body weight [Срок оценки: From baseline (week 0) to (week 80)]
- Change in apnoea-hypopnoea index (AHI) [Срок оценки: From baseline (week 0) to (week 80)]
Вторичные конечные точки (12)
- Relative change in AHI [Срок оценки: From baseline (week 0) to (week 80)]
- Achievement of 50% reduction in AHI (Yes/No) [Срок оценки: From baseline (week 0) to (week 80)]
- Achievement of: AHI less than (<) 5 [Срок оценки: From baseline (week 0) to (week 80)]
- Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No) [Срок оценки: From baseline (week 0) to (week 80)]
- Change in sleep apnoea specific hypoxic burden (SASHB) [Срок оценки: From baseline (week 0) to (week 80)]
- Change in ESS score [Срок оценки: From baseline (week 0) to (week 80)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score [Срок оценки: From baseline (week 0) to (week 80)]
- Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score [Срок оценки: From baseline (week 0) to (week 80)]
- Change in body weight [Срок оценки: From baseline (week 0) to (week 80)]
- Change in body mass index (BMI) [Срок оценки: From baseline (week 0) to (week 80)]
- Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No) [Срок оценки: From baseline (week 0) to (week 80)]
- Improvement in OSA severity category: ≥ 5 and < 15/hour = mild (Yes/No) [Срок оценки: From baseline (week 0) to (week 80)]
Критерии участия
Критерии включения
- Male or female (sex at birth)
- Age 18 years or above at the time of signing informed consent
- Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening
Критерии исключения
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening
- History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records
- Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy
- Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues 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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 20 центров
- Dignity Health, Mercy Gilbert — Gilbert
- DM Clinical — Bradenton
- Essence MD Research — Naples
- Palm Beach Research Center — West Palm Beach
- NeuroTrials Research, Inc. — Atlanta
- Physicians Research Associates — Lawrenceville
- Chicago Research Center, Inc — Chicago
- Weil Cornell Medicine — New York
- … и ещё 12 центров
Индия · 13 центров
- Guntur Government medical College — Guntur
- Government Siddhartha Medical College & Government General Hospital, Vijayawada — Vijayawada
- Rajarajeswari Medical College and Hospital — Bengaluru
- Amrita Institute Of Medical Sciences & Research Centre — Kochi
- Bhaktivedanta Hospital & Research Institute — Mumbai
- Asian Kidney Hospital And Medical Centre — Nagpur
- Vardhaman Mahavir Medical College & Safdarjung Hospital — New Delhi
- All India Institute of Medical Sciences_Delhi — Delhi
- … и ещё 5 центров
Япония · 10 центров
- Fukuoka University Hospital_Respiratory Medicine — Fukuoka
- Chatani NeuroSleep Clinic_Neurology — Hiroshima
- Kuwamizu Hospital_Internal Medicine — Kumamoto
- Nakamura Clinic_Pulmonology — Okinawa
- Osaka Kaisei Hospital_Sleep Medical Center — Osaka
- KKR Sappro Medical Center_Respiratory Medicine — Sapporo-shi, Hokkaido
- Chutoen General Medical Center_Neurology — Shizuoka
- Tokyo-Eki Center-building Clinic_Internal Medicine — Tokyo
- … и ещё 2 центра
Польша · 10 центров
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej — Wroclaw
- Uniwersyteckie Centrum Kliniczne — Gdansk
- Penta Hospitals Badania Kliniczne Sp. z o.o. — Gdansk
- 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej — Krakow
- Krakowski Szpital Specjalistyczny im. Jana Pawla II — Krakow
- Uniwersytecki Szpital Kliniczny W Poznaniu — Poznan
- Gyncentrum Sp. z o. o. — Warsaw
- National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc — Warsaw
- … и ещё 2 центра
Испания · 9 центров
- Hospital Universitario de Guadalajara — Guadalajara
- H.U. Quirónsalud Madrid — Pozuelo de Alarcón
- Hospital Vall d'Hebron — Barcelona
- Hospital Vithas Sevilla — Castilleja de la Cuesta
- Hospital Univ. de Santa María de Lleida — Lleida
- Hospital Universitario San Pedro — Logroño
- Hospital Ramón y Cajal — Madrid
- Instituto de Investigaciones del Sueño — Madrid
- … и ещё 1 центр
Turkey (Türkiye) · 8 центров
Список центров уточняется — проверьте первичный протокол.
Китай · 6 центров
- Peking University People's Hospital-Endocrinology — Пекин
- Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology — Гуанчжоу
- Shenzhen People's Hospital-Sleep Medicine Department — Шэньчжэнь
- The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology — Luoyang
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology — Нанкин
- Tianjin Medical University General Hospital-Respiratory — Тяньцзинь
Германия · 6 центров
- Siteworks GmbH Bochum — Bochum
- Wendisch - Dahl Hamburg - DZHW — Hamburg
- Siteworks GmbH Hannover — Hanover
- Siteworks GmbH Karlsruhe — Karlsruhe
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose — Münster
- Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio — Schleswig
Австралия · 5 центров
- Woolcock Institute — Macquarie Park
- University of Sunshine Coast - Vitality Village — Birtinya
- Mater Research - RIO Clinical Trials Unit — South Brisbane
- Nightingale Research Adelaide — Adelaide
- University of Western Australia - Centre for Sleep Science — Crawley
Тайвань · 5 центров
- Ditmanson Medical Foundation Chia-Yi Christian Hospital — Chiayi City
- … и ещё 4 центра
Идентификаторы
NCT: NCT07571109 · NN9490-8293 · U1111-1313-6538 · 2024-520443-16