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NOT YET RECRUITING
NCT07571005
PHASE3

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-05-05

Completion Date

2028-10-04

Last Updated

2026-05-06

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (80)

Artemis Insitute for Clin Res

San Diego, California, United States

PharmaDev Clinical Research Institute LLC

Miami, Florida, United States

Essence MD Research

Naples, Florida, United States

Ocala Lung & Critical Care Associates

Ocala, Florida, United States

NeuroTrials Research, Inc.

Atlanta, Georgia, United States

Physicians Research Associates

Lawrenceville, Georgia, United States

University Of Chicago

Chicago, Illinois, United States

Weil Cornell Medicine

New York, New York, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania, United States

Epic Medical Research

DeSoto, Texas, United States

Advanced Neurology Epilepsy and Sleep Center ANESC

El Paso, Texas, United States

Biorhythms Center for Integrative Sleep Medicine

El Paso, Texas, United States

Houston Pulmonary Medicine Associates, PA

Houston, Texas, United States

Sleep Therapy Research Center

San Antonio, Texas, United States

Tricoastal Sleep Center

Sugar Land, Texas, United States

Rainier Clin Res Ctr Inc

Renton, Washington, United States

Woolcock Institute

Macquarie Park, New South Wales, Australia

University of Sunshine Coast - Vitality Village

Birtinya, Queensland, Australia

Mater Research - RIO Clinical Trials Unit

South Brisbane, Queensland, Australia

Nightingale Research

Adelaide, South Australia, Australia

University of Western Australia - Centre for Sleep Science

Crawley, Western Australia, Australia

Peking University People's Hospital-Endocrinology

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University-Endocrinology

Suzhou, Jiangsu, China

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, China

Huzhou Central Hospital-Endocrinology

Huzhou, Zhejiang, China

Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk

Herning, Denmark

Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling

Køge, Denmark

Siteworks GmbH Bochum

Bochum, Germany

Wendisch - Dahl Hamburg - DZHW

Hamburg, Germany

Siteworks GmbH Hannover

Hanover, Germany

Siteworks GmbH Karlsruhe

Karlsruhe, Germany

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, Germany

Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio

Schleswig, Germany

Guntur Government medical College

Guntur, Andhra Pradesh, India

Government Siddhartha Medical College & Government General Hospital, Vijayawada

Vijayawada, Andhra Pradesh, India

Rajarajeswari Medical College and Hospital

Bengaluru, Karnataka, India

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, India

Bhaktivedanta Hospital & Research Institute

Mumbai, Maharashtra, India

Asian Kidney Hospital And Medical Centre

Nagpur, Maharashtra, India

All India Institute of Medical Sciences_Delhi

Delhi, New Delhi, India

All India Institute of Medical Sciences (AIIMS), Bhubaneswar

Bhubaneswar, Odisha, India

Yashoda Hospital

Hyderabad, Telangana, India

Midland Healthcare & Research Center

Lucknow, Uttar Pradesh, India

Apollo Multispeciality Hospital, Kolkata

Kolkata, West Bengal, India

Asthma Bhawan

Jaipur, India

Vardhaman Mahavir Medical College & Safdarjung Hospital

New Delhi, India

4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu

Wroclaw, Dolnoslaskie Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, Poland

5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie

Krakow, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, Poland

Uniwersytecki Szpital Kliniczny W Poznaniu

Poznan, Poland

Gyncentrum Sp. z o. o.

Warsaw, Poland

National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc

Warsaw, Poland

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, Poland

ETG Warszawa Sp. z o.o.

Warsaw, Poland

Hospital Universitario de Guadalajara

Guadalajara, Castille-La Mancha, Spain

H.U. Quirónsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Vithas Sevilla

Castilleja de la Cuesta, Spain

Hospital Univ. de Santa María de Lleida

Lleida, Spain

Hospital Universitario San Pedro

Logroño, Spain

Hospital Ramón y Cajal

Madrid, Spain

Instituto de Investigaciones del Sueño

Madrid, Spain

Hospital Universitario de Araba

Vitoria-Gasteiz, Spain

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, Taiwan

Cathay General Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan

T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları

Alanya/ Antalya, Turkey (Türkiye)

İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi

Maltepe/İstanbull, Turkey (Türkiye)

İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları

Merkez/Battalgazi/Malatya, Turkey (Türkiye)

Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları

Merkez/Çorum, Turkey (Türkiye)

Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları

Yenimahalle / Ankara, Turkey (Türkiye)

Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye

Yuregir/Adana, Turkey (Türkiye)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları

Yıldırım/Bursa, Turkey (Türkiye)

Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi

Zeytinburnu/İstanbul, Turkey (Türkiye)