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

NCT07571005 | Not Yet Recruiting Phase 3 FDA Drug

• 3 other identifiers: NN9490-8025U1111-1313-63592024-520442-36
• Study Type: interventional
• Target: 300
• Locations: 10 countries
• Sites: 80

Brief 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.

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 (30)

• 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 (80)

Artemis Insitute for Clin Res

San Diego, California, 92123, United States

Location

PharmaDev Clinical Research Institute LLC

Miami, Florida, 33176, United States

Location

Essence MD Research

Naples, Florida, 34102, United States

Location

Ocala Lung & Critical Care Associates

Ocala, Florida, 34471, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30328, United States

Location

Physicians Research Associates

Lawrenceville, Georgia, 30046, United States

Location

University Of Chicago

Chicago, Illinois, 60637, United States

Location

Weil Cornell Medicine

New York, New York, 10021, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania, 15801, United States

Location

Epic Medical Research

DeSoto, Texas, 75115, United States

Location

Advanced Neurology Epilepsy and Sleep Center ANESC

El Paso, Texas, 79912, United States

Location

Biorhythms Center for Integrative Sleep Medicine

El Paso, Texas, 79912, United States

Location

Houston Pulmonary Medicine Associates, PA

Houston, Texas, 77089, United States

Location

Sleep Therapy Research Center

San Antonio, Texas, 78229, United States

Location

Tricoastal Sleep Center

Sugar Land, Texas, 77478, United States

Location

Rainier Clin Res Ctr Inc

Renton, Washington, 98057, United States

Location

Woolcock Institute

Macquarie Park, New South Wales, 2113, Australia

Location

University of Sunshine Coast - Vitality Village

Birtinya, Queensland, 4575, Australia

Location

Mater Research - RIO Clinical Trials Unit

South Brisbane, Queensland, 4101, Australia

Location

Nightingale Research

Adelaide, South Australia, 5000, Australia

Location

University of Western Australia - Centre for Sleep Science

Crawley, Western Australia, 6009, Australia

Location

Peking University People's Hospital-Endocrinology

Beijing, Beijing Municipality, 100044, China

Location

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, 210011, China

Location

The First Affiliated Hospital of Soochow University-Endocrinology

Suzhou, Jiangsu, 215006, China

Location

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, 212001, China

Location

Huzhou Central Hospital-Endocrinology

Huzhou, Zhejiang, 313000, China

Location

Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk

Herning, 7400, Denmark

Location

Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling

Køge, 4600, Denmark

Location

Siteworks GmbH Bochum

Bochum, 44787, Germany

Location

Wendisch - Dahl Hamburg - DZHW

Hamburg, 22607, Germany

Location

Siteworks GmbH Hannover

Hanover, 30449, Germany

Location

Siteworks GmbH Karlsruhe

Karlsruhe, 76137, Germany

Location

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, 48145, Germany

Location

Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio

Schleswig, 24837, Germany

Location

Guntur Government medical College

Guntur, Andhra Pradesh, 522004,, India

Location

Government Siddhartha Medical College & Government General Hospital, Vijayawada

Vijayawada, Andhra Pradesh, 520008, India

Location

Rajarajeswari Medical College and Hospital

Bengaluru, Karnataka, 560074, India

Location

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, 682041, India

Location

Bhaktivedanta Hospital & Research Institute

Mumbai, Maharashtra, 401107, India

Location

Asian Kidney Hospital And Medical Centre

Nagpur, Maharashtra, 440010, India

Location

All India Institute of Medical Sciences_Delhi

Delhi, New Delhi, 110029, India

Location

All India Institute of Medical Sciences (AIIMS), Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

Yashoda Hospital

Hyderabad, Telangana, 500084, India

Location

Midland Healthcare & Research Center

Lucknow, Uttar Pradesh, 226006, India

Location

Apollo Multispeciality Hospital, Kolkata

Kolkata, West Bengal, 700054, India

Location

Asthma Bhawan

Jaipur, 302039, India

Location

Vardhaman Mahavir Medical College & Safdarjung Hospital

New Delhi, 110029, India

Location

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

Wroclaw, Dolnoslaskie Voivodeship, 50-981, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

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

Gdansk, 80-546, Poland

Location

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

Krakow, 30-901, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202, Poland

Location

Uniwersytecki Szpital Kliniczny W Poznaniu

Poznan, 60-569, Poland

Location

Gyncentrum Sp. z o. o.

Warsaw, 00-124, Poland

Location

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

Warsaw, 01-138, Poland

Location

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, 02-507, Poland

Location

ETG Warszawa Sp. z o.o.

Warsaw, 02-677, Poland

Location

Hospital Universitario de Guadalajara

Guadalajara, Castille-La Mancha, 19002, Spain

Location

H.U. Quirónsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Vithas Sevilla

Castilleja de la Cuesta, 41950, Spain

Location

Hospital Univ. de Santa María de Lleida

Lleida, 25198, Spain

Location

Hospital Universitario San Pedro

Logroño, 26006, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Instituto de Investigaciones del Sueño

Madrid, 28036, Spain

Location

Hospital Universitario de Araba

Vitoria-Gasteiz, 01004, Spain

Location

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, 600, Taiwan

Location

Cathay General Hospital

Taipei, 106, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology

Taipei, 116, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

Location

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

Alanya/ Antalya, 07400, Turkey (Türkiye)

Location

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

Maltepe/İstanbull, 34843, Turkey (Türkiye)

Location

İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları

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

Location

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

Merkez/Çorum, 19040, Turkey (Türkiye)

Location

Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları

Yenimahalle / Ankara, 06170, Turkey (Türkiye)

Location

Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye

Yuregir/Adana, 01060, Turkey (Türkiye)

Location

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları

Yıldırım/Bursa, 16310, Turkey (Türkiye)

Location

Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi

Zeytinburnu/İstanbul, 34020, Turkey (Türkiye)

Location

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): July 12, 2028
• Study Completion (Estimated): October 4, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (9); AU (5); US (17); IN (13); DK (2); TW (5); CN (5); TU (8); PL (10); DE (6)