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

NCT07571109 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: NN9490-8293U1111-1313-65382024-520443-16
• Study Type: interventional
• Target: 300
• Locations: 10 countries
• Sites: 92

Brief Summary

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.

Conditions

Obesity; Overweight; Obstructive Sleep Apnoea

Outcome Measures

Primary Outcomes (2)

• Relative change in body weight

  Measured as percentage (%) change in body weight.

  From baseline (week 0) to (week 80)

• Change in apnoea-hypopnoea index (AHI)

  Measured as events/hour.

  From baseline (week 0) to (week 80)

Secondary Outcomes (31)

• Relative change in AHI

  From baseline (week 0) to (week 80)

• Achievement of 50% reduction in AHI (Yes/No)

  From baseline (week 0) to (week 80)

• Achievement of: AHI less than (<) 5

  From baseline (week 0) to (week 80)

• Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)

  From baseline (week 0) to (week 80)

• Change in sleep apnoea specific hypoxic burden (SASHB)

  From baseline (week 0) to (week 80)

Study Arms (2)

NNC0487-0111

EXPERIMENTAL

Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Drug: NNC0487-0111

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Drug: Placebo (matched to NNC0487-0111)

Interventions

NNC0487-0111 DRUG

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

NNC0487-0111

Placebo (matched to NNC0487-0111) DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (92)

Dignity Health, Mercy Gilbert

Gilbert, Arizona, 85297, United States

RECRUITING

DM Clinical

Bradenton, Florida, 34209, United States

RECRUITING

Essence MD Research

Naples, Florida, 34102, United States

RECRUITING

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

RECRUITING

NeuroTrials Research, Inc.

Atlanta, Georgia, 30328, United States

RECRUITING

Physicians Research Associates

Lawrenceville, Georgia, 30046, United States

RECRUITING

Chicago Research Center, Inc

Chicago, Illinois, 60634, United States

RECRUITING

Weil Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

RECRUITING

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania, 15801, United States

NOT YET RECRUITING

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

RECRUITING

Epic Medical Research

DeSoto, Texas, 75115, United States

RECRUITING

Advanced Neurology Epilepsy and Sleep Center ANESC

El Paso, Texas, 79912, United States

RECRUITING

Biorhythms Center for Integrative Sleep Medicine

El Paso, Texas, 79912, United States

RECRUITING

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

Houston, Texas, 77089, United States

RECRUITING

Sleep Therapy Research Center

San Antonio, Texas, 78229, United States

RECRUITING

Tricoastal Sleep Center

Sugar Land, Texas, 77478, United States

RECRUITING

Rainier Clin Res Ctr Inc

Renton, Washington, 98057, United States

RECRUITING

Seattle Clinical Research Center

Seattle, Washington, 98104, United States

RECRUITING

Woolcock Institute

Macquarie Park, New South Wales, 2113, Australia

RECRUITING

University of Sunshine Coast - Vitality Village

Birtinya, Queensland, 4575, Australia

RECRUITING

Mater Research - RIO Clinical Trials Unit

South Brisbane, Queensland, 4101, Australia

NOT YET RECRUITING

Nightingale Research

Adelaide, South Australia, 5000, Australia

RECRUITING

University of Western Australia - Centre for Sleep Science

Crawley, Western Australia, 6009, Australia

RECRUITING

Peking University People's Hospital-Endocrinology

Beijing, Beijing Municipality, 100044, China

NOT YET RECRUITING

Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology

Guangzhou, Guangdong, 510515, China

NOT YET RECRUITING

Shenzhen People's Hospital-Sleep Medicine Department

Shenzhen, Guangdong, 518020, China

NOT YET RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology

Luoyang, Henan, 471003, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, 210011, China

NOT YET RECRUITING

Tianjin Medical University General Hospital-Respiratory

Tianjin, Tianjin Municipality, 300052, China

NOT YET RECRUITING

Siteworks GmbH Bochum

Bochum, 44787, Germany

RECRUITING

Wendisch - Dahl Hamburg - DZHW

Hamburg, 22607, Germany

RECRUITING

Siteworks GmbH Hannover

Hanover, 30449, Germany

RECRUITING

Siteworks GmbH Karlsruhe

Karlsruhe, 76137, Germany

RECRUITING

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, 48145, Germany

RECRUITING

Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio

Schleswig, 24837, Germany

RECRUITING

Guntur Government medical College

Guntur, Andhra Pradesh, 522004,, India

COMPLETED

Government Siddhartha Medical College & Government General Hospital, Vijayawada

Vijayawada, Andhra Pradesh, 520008, India

NOT YET RECRUITING

Rajarajeswari Medical College and Hospital

Bengaluru, Karnataka, 560074, India

NOT YET RECRUITING

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, 682041, India

NOT YET RECRUITING

Bhaktivedanta Hospital & Research Institute

Mumbai, Maharashtra, 401107, India

NOT YET RECRUITING

Asian Kidney Hospital And Medical Centre

Nagpur, Maharashtra, 440010, India

NOT YET RECRUITING

Vardhaman Mahavir Medical College & Safdarjung Hospital

New Delhi, National Capital Territory of Delhi, 110029, India

NOT YET RECRUITING

All India Institute of Medical Sciences_Delhi

Delhi, New Delhi, 110029, India

NOT YET RECRUITING

All India Institute of Medical Sciences (AIIMS), Bhubaneswar

Bhubaneswar, Odisha, 751019, India

NOT YET RECRUITING

Yashoda Hospital

Hyderabad, Telangana, 500084, India

COMPLETED

Midland Healthcare & Research Center

Lucknow, Uttar Pradesh, 226006, India

NOT YET RECRUITING

Apollo Multispeciality Hospital, Kolkata

Kolkata, West Bengal, 700054, India

NOT YET RECRUITING

Asthma Bhawan

Jaipur, 302039, India

NOT YET RECRUITING

Fukuoka University Hospital_Respiratory Medicine

Fukuoka, 814-0180, Japan

RECRUITING

Chatani NeuroSleep Clinic_Neurology

Hiroshima, 730-0051, Japan

RECRUITING

Kuwamizu Hospital_Internal Medicine

Kumamoto, 862-0954, Japan

RECRUITING

Nakamura Clinic_Pulmonology

Okinawa, 901-2132, Japan

RECRUITING

Osaka Kaisei Hospital_Sleep Medical Center

Osaka, 532-0003, Japan

RECRUITING

KKR Sappro Medical Center_Respiratory Medicine

Sapporo-shi, Hokkaido, 062-0931, Japan

RECRUITING

Chutoen General Medical Center_Neurology

Shizuoka, 436-8555, Japan

RECRUITING

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, 103-0027, Japan

RECRUITING

Juntendo University Hospital_Cardiovascular Biology And Medicine

Tokyo, 113-8431, Japan

RECRUITING

Tokyo Tenshi Hospital_Internal medicine

Tokyo, 193-0811, Japan

RECRUITING

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

Wroclaw, Dolnoslaskie Voivodeship, 50-981, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

RECRUITING

Penta Hospitals Badania Kliniczne Sp. z o.o.

Gdansk, 80-546, Poland

RECRUITING

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

Krakow, 30-901, Poland

NOT YET RECRUITING

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202, Poland

COMPLETED

Uniwersytecki Szpital Kliniczny W Poznaniu

Poznan, 60-569, Poland

RECRUITING

Gyncentrum Sp. z o. o.

Warsaw, 00-124, Poland

RECRUITING

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

Warsaw, 01-138, Poland

RECRUITING

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, 02-507, Poland

RECRUITING

ETG Warszawa Sp. z o.o.

Warsaw, 02-677, Poland

RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, Castille-La Mancha, 19002, Spain

RECRUITING

H.U. Quirónsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Vithas Sevilla

Castilleja de la Cuesta, 41950, Spain

RECRUITING

Hospital Univ. de Santa María de Lleida

Lleida, 25198, Spain

RECRUITING

Hospital Universitario San Pedro

Logroño, 26006, Spain

RECRUITING

Hospital Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Instituto de Investigaciones del Sueño

Madrid, 28036, Spain

RECRUITING

Hospital Universitario de Araba

Vitoria-Gasteiz, 01004, Spain

RECRUITING

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, 600, Taiwan

NOT YET RECRUITING

Cathay General Hospital

Taipei, 106, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology

Taipei, 116, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

NOT YET RECRUITING

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

Alanya/ Antalya, 07400, Turkey (Türkiye)

RECRUITING

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

Maltepe/İstanbull, 34843, Turkey (Türkiye)

RECRUITING

İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları

Merkez/Battalgazi/Malatya, 44280, Turkey (Türkiye)

RECRUITING

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

Merkez/Çorum, 19040, Turkey (Türkiye)

RECRUITING

Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları

Yenimahalle / Ankara, 06170, Turkey (Türkiye)

RECRUITING

Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye

Yuregir/Adana, 01060, Turkey (Türkiye)

RECRUITING

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları

Yıldırım/Bursa, 16310, Turkey (Türkiye)

RECRUITING

Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi

Zeytinburnu/İstanbul, 34020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): June 26, 2028
• Study Completion (Estimated): August 21, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (20); JP (10); DE (6); IN (13); AU (5); TU (8); PL (10); ES (9); TW (5); CN (6)