---
title: "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"
nct_id: NCT07571005
overall_status: NOT_YET_RECRUITING
phase: PHASE3
sponsor: Novo Nordisk A/S
study_type: INTERVENTIONAL
primary_condition: Obesity
countries: United States, Australia, China, Denmark, Germany, India, Poland, Spain, Taiwan, Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07571005.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07571005"
ct_last_update_post_date: 2026-05-06
last_seen_at: "2026-05-12T07:07:12.184Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**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)

**NCT ID:** [NCT07571005](https://clinicaltrials.gov/study/NCT07571005)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 300
- **Lead Sponsor:** Novo Nordisk A/S
- **Conditions:** Obesity, Overweight, Obstructive Sleep Apnoea
- **Start Date:** 2026-05-05
- **Completion Date:** 2028-10-04
- **CT.gov Last Update:** 2026-05-06

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.
- **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.

## 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.
- **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.

## Primary Outcomes

- **Relative change in body weight** _(time frame: From baseline (week 0) to (week 80))_ — Measured as percentage (%) change in body weight.
- **Change in apnoea-hypopnoea index (AHI)** _(time frame: From baseline (week 0) to (week 80))_ — Measured as events/hour.

## Secondary Outcomes

- **Relative change in AHI** _(time frame: From baseline (week 0) to (week 80))_
- **Achievement of 50% reduction in AHI (Yes/No)** _(time frame: From baseline (week 0) to (week 80))_
- **Achievement of: AHI less than (<) 5** _(time frame: From baseline (week 0) to (week 80))_
- **Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)** _(time frame: From baseline (week 0) to (week 80))_
- **Change in sleep apnoea specific hypoxic burden (SASHB)** _(time frame: From baseline (week 0) to (week 80))_
- **Change in ESS score** _(time frame: From baseline (week 0) to (week 80))_
- **Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score** _(time frame: From baseline (week 0) to (week 80))_
- **Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score** _(time frame: From baseline (week 0) to (week 80))_
- **Change in body weight** _(time frame: From baseline (week 0) to (week 80))_
- **Change in body mass index (BMI)** _(time frame: From baseline (week 0) to (week 80))_
- **Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)** _(time frame: From baseline (week 0) to (week 80))_
- **Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 5 and < 15/hour = mild (Yes/No)** _(time frame: From baseline (week 0) to (week 80))_
- **Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 15 and < 30/hour = moderate (Yes/No)** _(time frame: From baseline (week 0) to (week 80))_
- **Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 30/hour = severe (Yes/No)** _(time frame: From baseline (week 0) to (week 80))_
- **Change in waist circumference** _(time frame: From baseline (week 0) to (week 80))_
- **Change in neck circumference** _(time frame: From baseline (week 0) to (week 80))_
- **Change in systolic blood pressure (SBP)** _(time frame: From baseline (week 0) to (week 80))_
- **Change in diastolic blood pressure (DBP)** _(time frame: From baseline (week 0) to (week 80))_
- **Change in high-sensitivity C-reactive protein (hsCRP)** _(time frame: From baseline (week 0) to (week 80))_
- **Change in Total cholesterol** _(time frame: From baseline (week 0) to (week 80))_
- **Change in High-density lipoprotein (HDL) cholesterol** _(time frame: From baseline (week 0) to (week 80))_
- **Change in Low-density lipoprotein (LDL) cholesterol** _(time frame: From baseline (week 0) to (week 80))_
- **Chage in Very low-density lipoprotein (VLDL) cholesterol** _(time frame: From baseline (week 0) to (week 80))_
- **Change in Non-HDL cholesterol** _(time frame: From baseline (week 0) to (week 80))_
- **Change in Triglycerides** _(time frame: From baseline (week 0) to (week 80))_
- **Change in fasting plasma glucose** _(time frame: From baseline (week 0) to (week 80))_
- **Change in glycated haemoglobin (HbA1c)** _(time frame: From baseline (week 0) to (week 80))_
- **Number of Treatment emergent adverse events (TEAEs)** _(time frame: From baseline (week 0) to week 84)_
- **Number of Treatment emergent serious adverse events (TESAEs)** _(time frame: From baseline (week 0) to week 84)_
- **Number of TEAEs leading to permanent treatment discontinuation** _(time frame: From baseline (week 0) to week 84)_

## Locations (80)

- Artemis Insitute for Clin Res, San Diego, California, United States
- PharmaDev Clinical Research Institute LLC, Miami, Florida, United States
- Essence MD Research, Naples, Florida, United States
- Ocala Lung & Critical Care Associates, Ocala, Florida, United States
- NeuroTrials Research, Inc., Atlanta, Georgia, United States
- Physicians Research Associates, Lawrenceville, Georgia, United States
- University Of Chicago, Chicago, Illinois, United States
- Weil Cornell Medicine, New York, New York, United States
- CTI Clinical Research Center, Cincinnati, Ohio, United States
- Clinical Research Associates of Central PA, LLC, DuBois, Pennsylvania, United States
- Epic Medical Research, DeSoto, Texas, United States
- Advanced Neurology Epilepsy and Sleep Center ANESC, El Paso, Texas, United States
- Biorhythms Center for Integrative Sleep Medicine, El Paso, Texas, United States
- Houston Pulmonary Medicine Associates, PA, Houston, Texas, United States
- Sleep Therapy Research Center, San Antonio, Texas, United States
- Tricoastal Sleep Center, Sugar Land, Texas, United States
- Rainier Clin Res Ctr Inc, Renton, Washington, United States
- Woolcock Institute, Macquarie Park, New South Wales, Australia
- University of Sunshine Coast - Vitality Village, Birtinya, Queensland, Australia
- Mater Research - RIO Clinical Trials Unit, South Brisbane, Queensland, Australia
- Nightingale Research, Adelaide, South Australia, Australia
- University of Western Australia - Centre for Sleep Science, Crawley, Western Australia, Australia
- Peking University People's Hospital-Endocrinology, Beijing, Beijing Municipality, China
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology, Nanjing, Jiangsu, China
- The First Affiliated Hospital of Soochow University-Endocrinology, Suzhou, Jiangsu, China
- The Affiliated Hospital of Jiangsu University-Endocrinology, Zhenjiang, Jiangsu, China
- Huzhou Central Hospital-Endocrinology, Huzhou, Zhejiang, China
- Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk, Herning, Denmark
- Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling, Køge, Denmark
- Siteworks GmbH Bochum, Bochum, Germany
- Wendisch - Dahl Hamburg - DZHW, Hamburg, Germany
- Siteworks GmbH Hannover, Hanover, Germany
- Siteworks GmbH Karlsruhe, Karlsruhe, Germany
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, Germany
- Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio, Schleswig, Germany
- Guntur Government medical College, Guntur, Andhra Pradesh, India
- Government Siddhartha Medical College & Government General Hospital, Vijayawada, Vijayawada, Andhra Pradesh, India
- Rajarajeswari Medical College and Hospital, Bengaluru, Karnataka, India
- Amrita Institute Of Medical Sciences & Research Centre, Kochi, Kerala, India
- Bhaktivedanta Hospital & Research Institute, Mumbai, Maharashtra, India
- Asian Kidney Hospital And Medical Centre, Nagpur, Maharashtra, India
- All India Institute of Medical Sciences_Delhi, Delhi, New Delhi, India
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Bhubaneswar, Odisha, India
- Yashoda Hospital, Hyderabad, Telangana, India
- Midland Healthcare & Research Center, Lucknow, Uttar Pradesh, India
- Apollo Multispeciality Hospital, Kolkata, Kolkata, West Bengal, India
- Asthma Bhawan, Jaipur, India
- Vardhaman Mahavir Medical College & Safdarjung Hospital, New Delhi, India
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu, Wroclaw, Dolnoslaskie Voivodeship, Poland
- Uniwersyteckie Centrum Kliniczne, Gdansk, Poland
- Centrum Badan Klinicznych PI-House Sp. z o.o., Gdansk, Poland
- 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie, Krakow, Poland
- Krakowski Szpital Specjalistyczny im. Jana Pawla II, Krakow, Poland
- Uniwersytecki Szpital Kliniczny W Poznaniu, Poznan, Poland
- Gyncentrum Sp. z o. o., Warsaw, Poland
- National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc, Warsaw, Poland
- PANSTWOWY INSTYTUT MEDYCZNY MSWiA, Warsaw, Poland
- ETG Warszawa Sp. z o.o., Warsaw, Poland
- Hospital Universitario de Guadalajara, Guadalajara, Castille-La Mancha, Spain
- H.U. Quirónsalud Madrid, Pozuelo de Alarcón, Madrid, Spain
- Hospital Vall d'Hebron, Barcelona, Spain
- Hospital Vithas Sevilla, Castilleja de la Cuesta, Spain
- Hospital Univ. de Santa María de Lleida, Lleida, Spain
- Hospital Universitario San Pedro, Logroño, Spain
- Hospital Ramón y Cajal, Madrid, Spain
- Instituto de Investigaciones del Sueño, Madrid, Spain
- Hospital Universitario de Araba, Vitoria-Gasteiz, Spain
- Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi City, Taiwan
- Cathay General Hospital, Taipei, Taiwan
- Taipei Medical University Hospital, Taipei, Taiwan
- Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology, Taipei, Taiwan
- Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan
- T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları, Alanya/ Antalya, Turkey (Türkiye)
- İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi, Maltepe/İstanbull, Turkey (Türkiye)
- İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları, Merkez/Battalgazi/Malatya, Turkey (Türkiye)
- Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları, Merkez/Çorum, Turkey (Türkiye)
- Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları, Yenimahalle / Ankara, Turkey (Türkiye)
- Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye, Yuregir/Adana, Turkey (Türkiye)
- Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları, Yıldırım/Bursa, Turkey (Türkiye)
- Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi, Zeytinburnu/İstanbul, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

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- `locations.bursa yüksek i̇htisas eğitim ve araştırma hastanesi-göğüs hastalıkları|yıldırım/bursa||turkey (türkiye)` — added _(2026-05-12)_
- `locations.adana şehir eğitim ve araştırma hastanesi-dahiliye|yuregir/adana||turkey (türkiye)` — added _(2026-05-12)_
- `locations.ankara etlik şehir hastanesi-göğüs hastalıkları|yenimahalle / ankara||turkey (türkiye)` — added _(2026-05-12)_
- `locations.hitit üniversitesi çorum erol olçok eğitim ve araştırma hastanesi-göğüs hastalıkları|merkez/çorum||turkey (türkiye)` — added _(2026-05-12)_
- `locations.i̇nönü üniversitesi turgut özal tıp merkezi hastanesi- göğüs hastalıkları|merkez/battalgazi/malatya||turkey (türkiye)` — added _(2026-05-12)_
- `locations.i̇stanbul i̇l sağlik müdürlüğü süreyyapaşa göğüs hastaliklari ve göğüs cerrahisi eğitim ve araştirma hastanesi|maltepe/i̇stanbull||turkey (türkiye)` — added _(2026-05-12)_
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- `locations.chang gung memorial hospital, linkou|taoyuan||taiwan` — added _(2026-05-12)_
- `locations.taipei municipal wan fang hospital_division of otorhinolaryngology|taipei||taiwan` — added _(2026-05-12)_
- `locations.taipei medical university hospital|taipei||taiwan` — added _(2026-05-12)_
- `locations.cathay general hospital|taipei||taiwan` — added _(2026-05-12)_
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- `locations.hospital vall d'hebron|barcelona||spain` — added _(2026-05-12)_
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- `locations.national institute of tuberculosis and lung diseases - instytut gruźlicy i chorób płuc|warsaw||poland` — added _(2026-05-12)_
- `locations.gyncentrum sp. z o. o.|warsaw||poland` — added _(2026-05-12)_
- `locations.uniwersytecki szpital kliniczny w poznaniu|poznan||poland` — added _(2026-05-12)_
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- `locations.instituto de investigaciones del sueño|madrid||spain` — added _(2026-05-12)_
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- `locations.vardhaman mahavir medical college & safdarjung hospital|new delhi||india` — added _(2026-05-12)_
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- `locations.apollo multispeciality hospital, kolkata|kolkata|west bengal|india` — added _(2026-05-12)_
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- `locations.yashoda hospital|hyderabad|telangana|india` — added _(2026-05-12)_
- `locations.all india institute of medical sciences (aiims), bhubaneswar|bhubaneswar|odisha|india` — added _(2026-05-12)_
- `locations.all india institute of medical sciences_delhi|delhi|new delhi|india` — added _(2026-05-12)_
- `locations.asian kidney hospital and medical centre|nagpur|maharashtra|india` — added _(2026-05-12)_
- `locations.bhaktivedanta hospital & research institute|mumbai|maharashtra|india` — added _(2026-05-12)_
- `locations.amrita institute of medical sciences & research centre|kochi|kerala|india` — added _(2026-05-12)_
- `locations.rajarajeswari medical college and hospital|bengaluru|karnataka|india` — added _(2026-05-12)_
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- `locations.siteworks gmbh - prüfzentrum schleswig | respiratio|schleswig||germany` — added _(2026-05-12)_
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- `locations.wendisch - dahl hamburg - dzhw|hamburg||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07571005.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07571005*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*