NNC0487-0111 for weight loss in people with obesity and sleep apnoea using airway pressure
Tests NNC0487-0111 against placebo in adults with overweight or obesity and sleep apnoea.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Barcelona, Castilleja De La Cuesta, Guadalajara, Lleida, Logroño, Madrid, Pozuelo de Alarcón, and Vitoria, SpainSee the 9 sites
- Phase
- Phase 3
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Nisa Sevilla AljarafeCastilleja De La Cuesta, SpainTaking people
- Hospital Universitario De Guadalajara SESCAMGuadalajara, SpainTaking people
- Hospital Universitari de Santa MariaLleida, SpainTaking people
- Hospital San PedroLogroño, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Instituto De Investigaciones Del Sueno S.L.Madrid, SpainTaking people
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainTaking people
- Asociacion Instituto De Investigacion Sanitaria BioarabaVitoria, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07571109EU 2024-520443-16-00
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Treated With Positive Airway Pressure (AMAZE 4)
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.
Inclusion: 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.
Exclusion: 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; 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; History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records; Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence; Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.