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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified June 2026 by Novo Nordisk A/S
Sponsor
Novo Nordisk A/S
Information Provided by (Responsible Party)
Novo Nordisk A/S
Clinicaltrials.gov Identifier
NCT07571005
Other Study ID Numbers:
NN9490-8025
First Submitted
April 29, 2026
First Posted
May 5, 2026
Last Update Posted
July 12, 2026
Last Verified
June 2026

ClinicalTrials.gov processed this data on July 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
ObesityOverweightObstructive Sleep Apnoea
Drug: NNC0487-0111Drug: Placebo (matched to NNC0487-0111)

Study Design

Study TypeInterventional
Actual Enrollment300 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleEfficacy 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)
Study Start DateMay 4, 2026
Actual Primary Completion Date1yr 11mos from now
Actual Study Completion Date2yrs 2mos from now

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures
  1. Relative change in body weight
    Measured as percentage (%) change in body weight.
  2. Change in apnoea-hypopnoea index (AHI)
    Measured as events/hour.
Secondary Outcome Measures
  1. Relative change in AHI
    Measured as percentage change in AHI.
  2. Achievement of 50% reduction in AHI (Yes/No)
    Measured as number of participant.
  3. Achievement of: AHI less than (<) 5
    Measured as number of participants.
  4. Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)
    Measures as number of participants
  5. Change in sleep apnoea specific hypoxic burden (SASHB)
    Measured as percentage minutes per hour (%min/h).
  6. Change in ESS score
    Measured as score on a scale. ESS measures the level of daytime sleepiness or average sleep propensity. The measure consists of 8 items yielding one total score. Total score ranges from 0-24. Higher scores indicate higher sleepiness or average sleep propensity in daily life.
  7. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score
    Measured as score on a scale. PROMIS-SRI measures perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The measure consists of 8 items each rated on a 5-point scale ranging from &quot;not at all&quot; to &quot;very much&quot;. Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep-related impairment (ranging approximately from 30-80.1). Higher scores indicate more sleep-related impairment.
  8. Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score
    Measured as score on a scale. PROMIS-SD measures perceptions of sleep quality, sleep depth, and restoration associated with sleep. The measure consists of 8 items each rated on a 5-point scale ranging from &quot;not at all&quot; to &quot;very much,&quot; &quot;never&quot; to &quot;always,&quot; or &quot;very poor&quot; to &quot;very good&quot;. Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep disturbance (ranging approximately from 30-80.1). Higher scores indicate more sleep disturbance.
  9. Change in body weight
    Measured as kilogram (Kg).
  10. Change in body mass index (BMI)
    Measured as kilograms per meter square (kg/m\^2).
  11. Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)
    Measured as number of participants.
  12. Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 5 and < 15/hour = mild (Yes/No)
    Measured as number of participants.
  13. Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 15 and < 30/hour = moderate (Yes/No)
    Measured as number of participants.
  14. Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 30/hour = severe (Yes/No)
    Measured as number of participants.
  15. Change in waist circumference
    Measured as centimetre (cm).
  16. Change in neck circumference
    Measured as cm.
  17. Change in systolic blood pressure (SBP)
    Measured as millimetre of mercury (mmHg).
  18. Change in diastolic blood pressure (DBP)
    Measured as mmHg.
  19. Change in high-sensitivity C-reactive protein (hsCRP)
    Measured as ratio to baseline
  20. Change in Total cholesterol
    Measured as ratio to baseline.
  21. Change in High-density lipoprotein (HDL) cholesterol
    Measured as ratio to baseline.
  22. Change in Low-density lipoprotein (LDL) cholesterol
    Measured as ratio to baseline.
  23. Chage in Very low-density lipoprotein (VLDL) cholesterol
    Measured as ratio to baseline.
  24. Change in Non-HDL cholesterol
    Measured as ratio to baseline.
  25. Change in Triglycerides
    Measured as ratio to baseline.
  26. Change in fasting plasma glucose
    Measured as millimoles per litre (mmol/L).
  27. Change in glycated haemoglobin (HbA1c)
    Measured as % of HbA1c.
  28. Number of Treatment emergent adverse events (TEAEs)
    Measured as events.
  29. Number of Treatment emergent serious adverse events (TESAEs)
    Measured as Events.
  30. Number of TEAEs leading to permanent treatment discontinuation
    Measured as events.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsNovo Nordisk A/S
Locations
Artemis Insitute for Clin Res | San Diego California, United States, 92123PharmaDev Clinical Research Institute LLC | Miami Florida, United States, 33176Essence MD Research | Naples Florida, United States, 34102Renstar Medical Research | Ocala Florida, United States, 34470Conquest Research | Atlanta Georgia, United States, 30328Physicians Research Associates | Lawrenceville Georgia, United States, 30046University Of Chicago | Chicago Illinois, United States, 60637Weil Cornell Medicine | New York New York, United States, 10021CTI Clinical Research Center | Cincinnati Ohio, United States, 45212Clinical Research Associates of Central PA, LLC | DuBois Pennsylvania, United States, 15801Epic Medical Research | DeSoto Texas, United States, 75115Advanced Neurology Epilepsy and Sleep Center ANESC | El Paso Texas, United States, 79912Biorhythms Center for Integrative Sleep Medicine | El Paso Texas, United States, 79912Houston Pulmonary Medicine Associates, PA and Research Physicians Network, LLC | Houston Texas, United States, 77089Sleep Therapy Research Center | San Antonio Texas, United States, 78229Tricoastal Sleep Center | Sugar Land Texas, United States, 77478Rainier Clin Res Ctr Inc | Renton Washington, United States, 98057Woolcock Institute | Macquarie Park New South Wales, Australia, 2113University of Sunshine Coast - Vitality Village | Birtinya Queensland, Australia, 4575Mater Research - RIO Clinical Trials Unit | South Brisbane Queensland, Australia, 4101Nightingale Research | Adelaide South Australia, Australia, 5000University of Western Australia - Centre for Sleep Science | Crawley Western Australia, Australia, 6009Peking University People's Hospital-Endocrinology | Beijing Beijing Municipality, China, 100044The Second Affiliated Hospital of Nanjing Medical University-Endocrinology | Nanjing Jiangsu, China, 210011The First Affiliated Hospital of Soochow University-Endocrinology | Suzhou Jiangsu, China, 215006The Affiliated Hospital of Jiangsu University-Endocrinology | Zhenjiang Jiangsu, China, 212001Huzhou Central Hospital-Endocrinology | Huzhou Zhejiang, China, 313000Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk | Herning , Denmark, 7400Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling | Køge , Denmark, 4600Siteworks GmbH Bochum | Bochum , Germany, 44787Wendisch - Dahl Hamburg - DZHW | Hamburg , Germany, 22607Siteworks GmbH Hannover | Hanover , Germany, 30449Siteworks GmbH Karlsruhe | Karlsruhe , Germany, 76137Institut für Diabetesforschung GmbH Münster - Dr. med. Rose | Münster , Germany, 48145Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio | Schleswig , Germany, 24837Guntur Government medical College | Guntur Andhra Pradesh, India, 522004,Government Siddhartha Medical College & Government General Hospital, Vijayawada | Vijayawada Andhra Pradesh, India, 520008Rajarajeswari Medical College and Hospital | Bengaluru Karnataka, India, 560074Amrita Institute Of Medical Sciences & Research Centre | Kochi Kerala, India, 682041Bhaktivedanta Hospital & Research Institute | Mumbai Maharashtra, India, 401107Asian Kidney Hospital And Medical Centre | Nagpur Maharashtra, India, 440010All India Institute of Medical Sciences_Delhi | Delhi New Delhi, India, 110029All India Institute of Medical Sciences (AIIMS), Bhubaneswar | Bhubaneswar Odisha, India, 751019Yashoda Hospital | Hyderabad Telangana, India, 500084Midland Healthcare & Research Center | Lucknow Uttar Pradesh, India, 226006Apollo Multispeciality Hospital, Kolkata | Kolkata West Bengal, India, 700054Asthma Bhawan | Jaipur , India, 302039Vardhaman Mahavir Medical College & Safdarjung Hospital | New Delhi , India, 1100294 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu | Wroclaw Dolnoslaskie Voivodeship, Poland, 50-981Uniwersyteckie Centrum Kliniczne | Gdansk , Poland, 80-214Penta Hospitals Badania Kliniczne Sp. z o.o. | Gdansk , Poland, 80-5465 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie | Krakow , Poland, 30-901Krakowski Szpital Specjalistyczny im. Jana Pawla II | Krakow , Poland, 31-202Uniwersytecki Szpital Kliniczny W Poznaniu | Poznan , Poland, 60-569Gyncentrum Sp. z o. o. | Warsaw , Poland, 00-124National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc | Warsaw , Poland, 01-138PANSTWOWY INSTYTUT MEDYCZNY MSWiA | Warsaw , Poland, 02-507ETG Warszawa Sp. z o.o. | Warsaw , Poland, 02-677Hospital Universitario de Guadalajara | Guadalajara Castille-La Mancha, Spain, 19002H.U. Quirónsalud Madrid | Pozuelo de Alarcón Madrid, Spain, 28223Hospital Vall d'Hebron | Barcelona , Spain, 08035Hospital Vithas Sevilla | Castilleja de la Cuesta , Spain, 41950Hospital Univ. de Santa María de Lleida | Lleida , Spain, 25198Hospital Universitario San Pedro | Logroño , Spain, 26006Hospital Ramón y Cajal | Madrid , Spain, 28034Instituto de Investigaciones del Sueño | Madrid , Spain, 28036Hospital Universitario de Araba | Vitoria-Gasteiz , Spain, 01004Ditmanson Medical Foundation Chia-Yi Christian Hospital | Chiayi City , Taiwan, 600Cathay General Hospital | Taipei , Taiwan, 106Taipei Medical University Hospital | Taipei , Taiwan, 110Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology | Taipei , Taiwan, 116Chang Gung Memorial Hospital, Linkou | Taoyuan , Taiwan, 333T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları | Alanya/ Antalya , Turkey (Türkiye), 07400İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi | Maltepe/İstanbull , Turkey (Türkiye), 34843İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları | Merkez/Battalgazi/Malatya , Turkey (Türkiye), 44280Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları | Merkez/Çorum , Turkey (Türkiye), 19040Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları | Yenimahalle / Ankara , Turkey (Türkiye), 06170Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye | Yuregir/Adana , Turkey (Türkiye), 01060Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları | Yıldırım/Bursa , Turkey (Türkiye), 16310Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi | Zeytinburnu/İstanbul , Turkey (Türkiye), 34020
Investigators
Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S