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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

Novo Nordisk A/S

Start Date

5/5/2026

Completion Date

10/4/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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

Interventions

DRUG

NNC0487-0111

DRUG

Placebo (matched to NNC0487-0111)

Interested in This Trial?

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Conditions

ObesityOverweightObstructive Sleep Apnoea

Locations

Artemis Insitute for Clin Res

San Diego, California 92123

United States

PharmaDev Clinical Research Institute LLC

Miami, Florida 33176

United States

Essence MD Research

Naples, Florida 34102

United States

Renstar Medical Research

Ocala, Florida 34470

United States

Conquest Research

Atlanta, Georgia 30328

United States

Physicians Research Associates

Lawrenceville, Georgia 30046

United States

University Of Chicago

Chicago, Illinois 60637

United States

Weil Cornell Medicine

New York, New York 10021

United States

CTI Clinical Research Center

Cincinnati, Ohio 45212

United States

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania 15801

United States

Epic Medical Research

DeSoto, Texas 75115

United States

Advanced Neurology Epilepsy and Sleep Center ANESC

El Paso, Texas 79912

United States

Biorhythms Center for Integrative Sleep Medicine

El Paso, Texas 79912

United States

Houston Pulmonary Medicine Associates, PA and Research Physicians Network, LLC

Houston, Texas 77089

United States

Sleep Therapy Research Center

San Antonio, Texas 78229

United States

Tricoastal Sleep Center

Sugar Land, Texas 77478

United States

Rainier Clin Res Ctr Inc

Renton, Washington 98057

United States

Woolcock Institute

Macquarie Park, New South Wales 2113

Australia

University of Sunshine Coast - Vitality Village

Birtinya, Queensland 4575

Australia

Mater Research - RIO Clinical Trials Unit

South Brisbane, Queensland 4101

Australia

Nightingale Research

Adelaide, South Australia 5000

Australia

University of Western Australia - Centre for Sleep Science

Crawley, Western Australia 6009

Australia

Peking University People's Hospital-Endocrinology

Beijing, Beijing Municipality 100044

China

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu 210011

China

The First Affiliated Hospital of Soochow University-Endocrinology

Suzhou, Jiangsu 215006

China

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu 212001

China

Huzhou Central Hospital-Endocrinology

Huzhou, Zhejiang 313000

China

Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk

Herning, 7400

Denmark

Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling

Køge, 4600

Denmark

Siteworks GmbH Bochum

Bochum, 44787

Germany

Wendisch - Dahl Hamburg - DZHW

Hamburg, 22607

Germany

Siteworks GmbH Hannover

Hanover, 30449

Germany

Siteworks GmbH Karlsruhe

Karlsruhe, 76137

Germany

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, 48145

Germany

Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio

Schleswig, 24837

Germany

Guntur Government medical College

Guntur, Andhra Pradesh 522004,

India

Government Siddhartha Medical College & Government General Hospital, Vijayawada

Vijayawada, Andhra Pradesh 520008

India

Rajarajeswari Medical College and Hospital

Bengaluru, Karnataka 560074

India

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala 682041

India

Bhaktivedanta Hospital & Research Institute

Mumbai, Maharashtra 401107

India

Asian Kidney Hospital And Medical Centre

Nagpur, Maharashtra 440010

India

All India Institute of Medical Sciences_Delhi

Delhi, New Delhi 110029

India

All India Institute of Medical Sciences (AIIMS), Bhubaneswar

Bhubaneswar, Odisha 751019

India

Yashoda Hospital

Hyderabad, Telangana 500084

India

Midland Healthcare & Research Center

Lucknow, Uttar Pradesh 226006

India

Apollo Multispeciality Hospital, Kolkata

Kolkata, West Bengal 700054

India

Asthma Bhawan

Jaipur, 302039

India

Vardhaman Mahavir Medical College & Safdarjung Hospital

New Delhi, 110029

India

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

Wroclaw, Dolnoslaskie Voivodeship 50-981

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

Penta Hospitals Badania Kliniczne Sp. z o.o.

Gdansk, 80-546

Poland

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

Krakow, 30-901

Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202

Poland

Uniwersytecki Szpital Kliniczny W Poznaniu

Poznan, 60-569

Poland

Gyncentrum Sp. z o. o.

Warsaw, 00-124

Poland

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

Warsaw, 01-138

Poland

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, 02-507

Poland

ETG Warszawa Sp. z o.o.

Warsaw, 02-677

Poland

Hospital Universitario de Guadalajara

Guadalajara, Castille-La Mancha 19002

Spain

H.U. Quirónsalud Madrid

Pozuelo de Alarcón, Madrid 28223

Spain

Hospital Vall d'Hebron

Barcelona, 08035

Spain

Hospital Vithas Sevilla

Castilleja de la Cuesta, 41950

Spain

Hospital Univ. de Santa María de Lleida

Lleida, 25198

Spain

Hospital Universitario San Pedro

Logroño, 26006

Spain

Hospital Ramón y Cajal

Madrid, 28034

Spain

Instituto de Investigaciones del Sueño

Madrid, 28036

Spain

Hospital Universitario de Araba

Vitoria-Gasteiz, 01004

Spain

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, 600

Taiwan

Cathay General Hospital

Taipei, 106

Taiwan

Taipei Medical University Hospital

Taipei, 110

Taiwan

Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology

Taipei, 116

Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333

Taiwan

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

Alanya/ Antalya, 07400

Turkey (Türkiye)

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

Maltepe/İstanbull, 34843

Turkey (Türkiye)

İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları

Merkez/Battalgazi/Malatya, 44280

Turkey (Türkiye)

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

Merkez/Çorum, 19040

Turkey (Türkiye)

Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları

Yenimahalle / Ankara, 06170

Turkey (Türkiye)

Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye

Yuregir/Adana, 01060

Turkey (Türkiye)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları

Yıldırım/Bursa, 16310

Turkey (Türkiye)

Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi

Zeytinburnu/İstanbul, 34020

Turkey (Türkiye)