AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

Официальное название

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure (AMAZE 3)

Обзор

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. 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 obstructive sleep apnoea (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 · 17 центров

• Artemis Insitute for Clin Res — San Diego
• PharmaDev Clinical Research Institute LLC — Miami
• Essence MD Research — Naples
• Renstar Medical Research — Ocala
• Conquest Research — Atlanta
• Physicians Research Associates — Lawrenceville
• University Of Chicago — Chicago
• Weil Cornell Medicine — New York
• … и ещё 9 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
• All India Institute of Medical Sciences_Delhi — Delhi
• All India Institute of Medical Sciences (AIIMS), Bhubaneswar — Bhubaneswar
• … и ещё 5 центров

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

• T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi- — Alanya/ Antalya
• İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve A — Maltepe/İstanbull
• İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları — Merkez/Battalgazi/Malatya
• Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları — Merkez/Çorum
• Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları — Yenimahalle / Ankara
• Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye — Yuregir/Adana
• Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları — Yıldırım/Bursa
• Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi — Zeytinburnu/İstanbul

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
• University of Western Australia - Centre for Sleep Science — Crawley

Китай · 5 центров

• Peking University People's Hospital-Endocrinology — Пекин
• The Second Affiliated Hospital of Nanjing Medical University-Endocrinology — Нанкин
• The First Affiliated Hospital of Soochow University-Endocrinology — Сучжоу
• The Affiliated Hospital of Jiangsu University-Endocrinology — Zhenjiang
• Huzhou Central Hospital-Endocrinology — Huzhou

Тайвань · 5 центров

• Ditmanson Medical Foundation Chia-Yi Christian Hospital — Chiayi City
• Cathay General Hospital — Taipei
• Taipei Medical University Hospital — Taipei
• Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology — Taipei
• Chang Gung Memorial Hospital, Linkou — Taoyuan

Дания · 2 центра

• Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk — Herning
• Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling — Køge

Идентификаторы

NCT: NCT07571005 · NN9490-8025 · U1111-1313-6359 · 2024-520442-36

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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