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
- Bengaluru, Bhubaneswar, Delhi, Guntur, Hyderabad, Jaipur, Kochi, Kolkata, Lucknow, Mumbai, Nagpur, New Delhi, and Vijayawada, IndiaSee the 13 sitesAlso in 9 other countries, 78 sites
- Trial code
- NCT07571109
- EU 2024-520443-16-00
- U1111-1313-6538
- 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 India
Also in 9 other countries, 78 sites
- Rajarajeswari Medical College and HospitalBengaluru, IndiaContact: Novo NordiskTaking people
- All India Institute of Medical Sciences (AIIMS) - BhubaneswarBhubaneswar, IndiaContact: Novo NordiskNot yet recruiting
- All India Institute of Medical Sciences-DelhiDelhi, IndiaContact: Novo NordiskTaking people
- Guntur Government medical CollegeGuntur, IndiaContact: Novo NordiskNo longer taking part
- Yashoda HospitalHyderabad, IndiaContact: Novo NordiskNo longer taking part
- Asthma BhawanJaipur, IndiaContact: Novo NordiskTaking people
- Amrita Institute of Medical Sciences & Research CentreKochi, IndiaContact: Novo NordiskTaking people
- Apollo Multispeciality Hospital, KolkataKolkata, IndiaContact: Novo NordiskTaking people
- Midland Healthcare & Research CenterLucknow, IndiaContact: Novo NordiskTaking people
- Bhaktivedanta Hospital & Research InstituteMumbai, IndiaContact: Novo NordiskTaking people
- Asian Kidney Hospital and Medical CentreNagpur, IndiaContact: Novo NordiskTaking people
- Vardhaman Mahavir Medical College & Safdarjung HospitalNew Delhi, IndiaContact: Novo NordiskTaking people
- Government Siddhartha Medical College & Government General Hospital, VijayawadaVijayawada, IndiaContact: Novo NordiskTaking 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
- 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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