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ObesityPhase 3AMAZE 3NCT07571005

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

A Phase 3 study testing NNC0487-0111 in people with Obesity and Overweight, run by Novo Nordisk A/S at 80 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight, Obstructive Sleep Apnoea
What is being tested?
NNC0487-0111
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
80 sitesin 10 countries
Study dates
5 May 2026to 4 Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

80 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

80 sites in 10 countries

United States17 sites, 17 recruiting

  • Conquest Research

    Atlanta, Georgia, 30328

    Recruiting

  • University Of Chicago

    Chicago, Illinois, 60637

    Recruiting

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

    Recruiting

  • Epic Medical Research

    DeSoto, Texas, 75115

    Recruiting

  • Clinical Research Associates of Central PA, LLC

    DuBois, Pennsylvania, 15801

    Not yet recruiting

  • Advanced Neurology Epilepsy and Sleep Center ANESC

    El Paso, Texas, 79912

    Recruiting

  • Biorhythms Center for Integrative Sleep Medicine

    El Paso, Texas, 79912

    Recruiting

  • Houston Pulm Med Res Network

    Houston, Texas, 77089

    Recruiting

  • Physicians Research Associates

    Lawrenceville, Georgia, 30046

    Recruiting

  • PharmaDev Clinical Research Institute LLC

    Miami, Florida, 33176

    Recruiting

  • Essence MD Research

    Naples, Florida, 34102

    Not yet recruiting

  • Weil Cornell Medicine

    New York, New York, 10021

    Recruiting

  • Renstar Medical Research

    Ocala, Florida, 34470

    Recruiting

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

    Recruiting

  • Sleep Therapy Research Center

    San Antonio, Texas, 78229

    Recruiting

  • Artemis Insitute for Clin Res

    San Diego, California, 92123

    Recruiting

  • Tricoastal Sleep Center

    Sugar Land, Texas, 77478

    Recruiting

Other trials in United States

India13 sites, 11 recruiting

  • Rajarajeswari Medical College and Hospital

    Bengaluru, Karnataka, 560074

    Recruiting

  • All India Institute of Medical Sciences (AIIMS), Bhubaneswar

    Bhubaneswar, Odisha, 751019

    Not yet recruiting

  • All India Institute of Medical Sciences_Delhi

    Delhi, New Delhi, 110029

    Not yet recruiting

  • Guntur Government medical College

    Guntur, Andhra Pradesh, 522004,

    Completed

  • Yashoda Hospital

    Hyderabad, Telangana, 500084

    Completed

  • Asthma Bhawan

    Jaipur, 302039

    Recruiting

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala, 682041

    Recruiting

  • Apollo Multispeciality Hospital, Kolkata

    Kolkata, West Bengal, 700054

    Recruiting

  • Midland Healthcare & Research Center

    Lucknow, Uttar Pradesh, 226006

    Recruiting

  • Bhaktivedanta Hospital & Research Institute

    Mumbai, Maharashtra, 401107

    Recruiting

  • Asian Kidney Hospital And Medical Centre

    Nagpur, Maharashtra, 440010

    Recruiting

  • Vardhaman Mahavir Medical College & Safdarjung Hospital

    New Delhi, 110029

    Recruiting

  • Government Siddhartha Medical College & Government General Hospital, Vijayawada

    Vijayawada, Andhra Pradesh, 520008

    Recruiting

Other trials in India

Poland10 sites, 9 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Recruiting

  • Penta Hospitals Badania Kliniczne Sp. z o.o.

    Gdansk, 80-546

    Recruiting

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

    Krakow, 30-901

    Recruiting

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Krakow, 31-202

    Completed

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    Poznan, 60-569

    Recruiting

  • Gyncentrum Sp. z o. o.

    Warsaw, 00-124

    Recruiting

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

    Warsaw, 01-138

    Recruiting

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warsaw, 02-507

    Recruiting

  • ETG Warszawa Sp. z o.o.

    Warsaw, 02-677

    Recruiting

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

    Wroclaw, Dolnoslaskie Voivodeship, 50-981

    Recruiting

Other trials in Poland

Spain9 sites, 9 recruiting

  • Hospital Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, 41950

    Recruiting

  • Hospital Universitario de Guadalajara

    Guadalajara, Castille-La Mancha, 19002

    Recruiting

  • Hospital Univ. de Santa María de Lleida

    Lleida, 25198

    Recruiting

  • Hospital Universitario San Pedro

    Logroño, 26006

    Recruiting

  • Hospital Ramón y Cajal

    Madrid, 28034

    Recruiting

  • Instituto de Investigaciones del Sueño

    Madrid, 28036

    Recruiting

  • H.U. Quirónsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

    Recruiting

  • Hospital Universitario de Araba

    Vitoria-Gasteiz, 01004

    Recruiting

Other trials in Spain

Turkey (Türkiye)8 sites, 8 recruiting

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

    Alanya/ Antalya, 07400

    Recruiting

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

    Maltepe/İstanbull, 34843

    Recruiting

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları

    Merkez/Battalgazi/Malatya, 44280

    Recruiting

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

    Merkez/Çorum, 19040

    Recruiting

  • Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları

    Yenimahalle / Ankara, 06170

    Recruiting

  • Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları

    Yıldırım/Bursa, 16310

    Recruiting

  • Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye

    Yuregir/Adana, 01060

    Recruiting

  • Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi

    Zeytinburnu/İstanbul, 34020

    Recruiting

Other trials in Turkey (Türkiye)

Germany6 sites, 6 recruiting

  • Siteworks GmbH Bochum

    Bochum, 44787

    Recruiting

  • Wendisch - Dahl Hamburg - DZHW

    Hamburg, 22607

    Recruiting

  • Siteworks GmbH Hannover

    Hanover, 30449

    Recruiting

  • Siteworks GmbH Karlsruhe

    Karlsruhe, 76137

    Recruiting

  • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

    Münster, 48145

    Recruiting

  • Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio

    Schleswig, 24837

    Recruiting

Other trials in Germany

Australia5 sites, 5 recruiting

  • Nightingale Research Adelaide

    Adelaide, South Australia, 5000

    Recruiting

  • University of Sunshine Coast - Vitality Village

    Birtinya, Queensland, 4575

    Recruiting

  • University of Western Australia - Centre for Sleep Science

    Crawley, Western Australia, 6009

    Recruiting

  • Woolcock Institute

    Macquarie Park, New South Wales, 2113

    Recruiting

  • Mater Research - RIO Clinical Trials Unit

    South Brisbane, Queensland, 4101

    Not yet recruiting

Other trials in Australia

China5 sites, 5 recruiting

  • Peking University People's Hospital-Endocrinology

    Beijing, Beijing Municipality, 100044

    Recruiting

  • Huzhou Central Hospital-Endocrinology

    Huzhou, Zhejiang, 313000

    Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu, 210011

    Recruiting

  • The First Affiliated Hospital of Soochow University-Endocrinology

    Suzhou, Jiangsu, 215006

    Recruiting

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu, 212001

    Recruiting

Other trials in China

Taiwan5 sites, 5 recruiting

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

    Chiayi City, 600

    Not yet recruiting

  • Cathay General Hospital

    Taipei, 106

    Recruiting

  • Taipei Medical University Hospital

    Taipei, 110

    Recruiting

  • Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology

    Taipei, 116

    Recruiting

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Denmark2 sites, 2 recruiting

  • Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk

    Herning, 7400

    Recruiting

  • Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling

    Køge, 4600

    Recruiting

Other trials in Denmark

About this study

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)

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.

Being tested
NNC0487-0111, Placebo (matched to NNC0487-0111)
Medical subject headings
Obesity, Overweight, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0487-0111Drug

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

  • 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.

Study groups in NCT07571005
Study groupRoleWhat they receive
NNC0487-0111ExperimentalParticipants 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.
Receives: Drug: NNC0487-0111
PlaceboPlacebo comparatorParticipants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Receives: Drug: Placebo (matched to NNC0487-0111)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative change in body weight

    Measured as percentage (%) change in body weight.

    Measured: From baseline (week 0) to (week 80)

  2. Change in apnoea-hypopnoea index (AHI)

    Measured as events/hour.

    Measured: From baseline (week 0) to (week 80)

Secondary outcomes (30)

  1. Relative change in AHI

    Measured as percentage change in AHI.

    Measured: From baseline (week 0) to (week 80)

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

    Measured as number of participant.

    Measured: From baseline (week 0) to (week 80)

  3. Achievement of: AHI less than (<) 5

    Measured as number of participants.

    Measured: From baseline (week 0) to (week 80)

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

    Measures as number of participants

    Measured: From baseline (week 0) to (week 80)

  5. Change in sleep apnoea specific hypoxic burden (SASHB)

    Measured as percentage minutes per hour (%min/h).

    Measured: From baseline (week 0) to (week 80)

  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.

    Measured: From baseline (week 0) to (week 80)

  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 "not at all" to "very much". 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.

    Measured: From baseline (week 0) to (week 80)

  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 "not at all" to "very much," "never" to "always," or "very poor" to "very good". 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.

    Measured: From baseline (week 0) to (week 80)

  9. Change in body weight

    Measured as kilogram (Kg).

    Measured: From baseline (week 0) to (week 80)

  10. Change in body mass index (BMI)

    Measured as kilograms per meter square (kg/m^2).

    Measured: From baseline (week 0) to (week 80)

  11. Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)

    Measured as number of participants.

    Measured: From baseline (week 0) to (week 80)

  12. Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 5 and < 15/hour = mild (Yes/No)

    Measured as number of participants.

    Measured: From baseline (week 0) to (week 80)

  13. Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 15 and < 30/hour = moderate (Yes/No)

    Measured as number of participants.

    Measured: From baseline (week 0) to (week 80)

  14. Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 30/hour = severe (Yes/No)

    Measured as number of participants.

    Measured: From baseline (week 0) to (week 80)

  15. Change in waist circumference

    Measured as centimetre (cm).

    Measured: From baseline (week 0) to (week 80)

  16. Change in neck circumference

    Measured as cm.

    Measured: From baseline (week 0) to (week 80)

  17. Change in systolic blood pressure (SBP)

    Measured as millimetre of mercury (mmHg).

    Measured: From baseline (week 0) to (week 80)

  18. Change in diastolic blood pressure (DBP)

    Measured as mmHg.

    Measured: From baseline (week 0) to (week 80)

  19. Change in high-sensitivity C-reactive protein (hsCRP)

    Measured as ratio to baseline

    Measured: From baseline (week 0) to (week 80)

  20. Change in Total cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  21. Change in High-density lipoprotein (HDL) cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  22. Change in Low-density lipoprotein (LDL) cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  23. Chage in Very low-density lipoprotein (VLDL) cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  24. Change in Non-HDL cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  25. Change in Triglycerides

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to (week 80)

  26. Change in fasting plasma glucose

    Measured as millimoles per litre (mmol/L).

    Measured: From baseline (week 0) to (week 80)

  27. Change in glycated haemoglobin (HbA1c)

    Measured as % of HbA1c.

    Measured: From baseline (week 0) to (week 80)

  28. Number of Treatment emergent adverse events (TEAEs)

    Measured as events.

    Measured: From baseline (week 0) to week 84

  29. Number of Treatment emergent serious adverse events (TESAEs)

    Measured as Events.

    Measured: From baseline (week 0) to week 84

  30. Number of TEAEs leading to permanent treatment discontinuation

    Measured as events.

    Measured: From baseline (week 0) to week 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start5 May 2026
  3. Primary completion12 Jul 2028 (estimated)
  4. Study completion4 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07571005
Sponsor's protocol ID
NN9490-8025
Other IDs
U1111-1313-6359, 2024-520442-36
Acronym
AMAZE 3
Status last verified
Sep 2026
First submitted
30 Apr 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NNC0487-0111 in people with Obesity and Overweight, run by Novo Nordisk A/S at 80 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, India, Poland, Spain, Turkey (Türkiye) and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change in body weight (time frame: From baseline (week 0) to (week 80)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07571005.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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