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Taking people in SpainPhase 3

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.

Key facts

Who runs it
Novo Nordisk A/S
Where
Barcelona, Castilleja De La Cuesta, Guadalajara, Lleida, Logroño, Madrid, Pozuelo de Alarcón, and Vitoria, SpainSee the 9 sitesAlso in 9 other countries, 82 sites
Trial code
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
Status
Recruiting
Phase
Phase 3
People taking part
300 people, planned
Started
5 May 2026
Expected to end
21 Aug 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • NNC0487-0111
  • Placebo (matched to NNC0487-0111)
Record updated
7 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with overweight or obesity and moderate-to-severe obstructive sleep apnoea who are treated with positive airway pressure (PAP). People get NNC0487-0111 or placebo as a weekly injection under the skin.

Age
18 years or older
Sex
Men and women (sex at birth)
Disease stage
Obstructive sleep apnoea diagnosed before screening as moderate-to-severe, with an AHI of 15 or more, and treated with positive airway pressure
Earlier treatment
Cannot have had GLP-1 receptor agonist, dual GLP-1/GIP, other GLP-1 based treatment or amylin analogue treatment before screening
Biomarker or test result
HbA1c must be below 6.5% (48 mmol/mol) at screening

Main reasons for not taking part

  • HbA1c of 6.5% (48 mmol/mol) or higher at screening
  • History of type 1 or type 2 diabetes
  • Surgery for sleep apnoea planned or done within 90 days before screening
  • Significant craniofacial abnormalities that may affect breathing, for example Treacher Collins syndrome or Pierre Robin Sequence
  • Treatment with GLP-1 receptor agonists, dual GLP-1/GIP agonists, other GLP-1 based treatment or amylin analogues before screening

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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 take part

  • 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

Where in Spain

Also in 9 other countries, 82 sites

  • 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

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • NNC0487-0111Treatment being tested

    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.

  • PlaceboPlacebo, for comparison

    Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

    Treatment: Placebo (matched to NNC0487-0111)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
NNC0487-0111 for weight loss in people with obesity and sleep apnoea using airway pressureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
7 October 2026