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AMAZE 4: NNC0487-0111 for Excess Body Weight and Obstructive Sleep Apnoea

This study, called AMAZE 4, is looking at a medicine called NNC0487-0111. It's for people who are overweight or have obesity and also have obstructive sleep apnoea (OSA), a condition where breathing repeatedly stops and starts during sleep, and are already using a positive airway pressure (PAP) machine. You would receive weekly injections under the skin of either NNC0487-0111 or a placebo (a substance with no active medicine). The study aims to see if NNC0487-0111 helps with weight loss and improves your sleep apnoea. To join, you need to be at least 18 years old and have been diagnosed with moderate-to-severe OSA. The study will measure changes in body weight and your apnoea-hypopnoea index (AHI), which is a measure of sleep apnoea severity, over 80 weeks.

Study design
This is an interventional study planning to enroll 300 participants. You would be randomly assigned to receive either NNC0487-0111 or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your body weight and apnoea-hypopnoea index (AHI) will be measured from the start of the study (week 0) to week 80.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07571109

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Novo Nordisk A/S
~300 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:NNC0487-0111Placebo (matched to NNC0487-0111)

At a glance

Recruiting sites
76 of 92 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative change in body weight
Measured over From baseline (week 0) to (week 80)
+1 more outcome measured

Conditions

Obesity
Overweight
Obstructive Sleep Apnoea

Explore related trials

ObesityObstructive Sleep ApneaOverweight

Where it's being run

92 sites across 40 states
Japan10
Poland9
Turkey (Türkiye)8
Spain7
Texas6
Germany6
Taiwan5
Florida3

Study leadership

  • Clinical Transparency dept. 2834 · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

Novo Nordisk
[email protected]
(+1) 866-867-7178
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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

What this trial measures

  • Relative change in body weightFrom baseline (week 0) to (week 80)

    Measured as percentage (%) change in body weight.

  • Change in apnoea-hypopnoea index (AHI)From baseline (week 0) to (week 80)

    Measured as events/hour.