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Trial · Interventional

RecruitingPhase 3Registry data

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

Short name AMAZE 4

NCTNCT07571109 (opens ClinicalTrials.gov in a new tab)Other idNN9490-8293Other idU1111-1313-6538Other id2024-520443-16
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
300 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
10 countries

United States, Australia, China, Germany, India, Japan, Poland, Spain, Taiwan, Turkey (Türkiye)

Start
5 May 2026
Primary completion
26 Jun 2028 (estimated)
Completion
21 Aug 2028 (estimated)
First posted
6 May 2026
Last update posted
7 Oct 2026
Conditions
Obesity · Overweight · Obstructive Sleep Apnoea

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 3

    AMAZE 4

    NCT07571109

    5 May 2026 to est. 21 Aug 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • NNC0487-0111Drug
  • Placebo (matched to NNC0487-0111)Drug

Arms2

  • Experimental

    NNC0487-0111

    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 comparator

    Placebo

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Relative change in body weight

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as percentage (%) change in body weight.

  2. Change in apnoea-hypopnoea index (AHI)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as events/hour.

Secondary outcomes(20)

  1. Relative change in AHI

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as percentage change in AHI.

  2. Achievement of 50% reduction in AHI (Yes/No)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as number of participant.

  3. Achievement of: AHI less than (<) 5

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as number of participants.

  4. Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as number of participants.

  5. Change in sleep apnoea specific hypoxic burden (SASHB)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    measured as %min/h (percentage minutes per hour).

  6. Change in ESS score

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as score on a scale. ESS measures the level of daytime sleepiness or average sleep propensity. The measure consists of 8 items yielding one total score. Total score ranges from 0-24. Higher scores indicate higher sleepiness or average sleep propensity in daily life.

  7. 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)

    Registry description

    Measured as score on a scale. PROMIS-SRI measures perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakeful-ness associated with sleep problems or impaired alertness. The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much". Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep-related impairment (ranging approximately from 30-80.1). Higher scores indicate more sleep-related impairment.

  8. Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as score on a scale. PROMIS-SD measures perceptions of sleep quality, sleep depth, and restoration associated with sleep. The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good". Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep disturbance (ranging approximately from 30-80.1). Higher scores indicate more sleep disturbance.

  9. Change in body weight

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as kilogram (Kg).

  10. Change in body mass index (BMI)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as kilograms per meter square (kg/m\^2).

  11. Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as number of participants.

  12. Improvement in OSA severity category: ≥ 5 and < 15/hour = mild (Yes/No)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as number of participants.

  13. Improvement in OSA severity category: ≥ 15 and < 30/hour = moderate (Yes/No)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as number of participants.

  14. Improvement in OSA severity category: ≥ 30/hour = severe (Yes/No)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as number of participants.

  15. Withdrawal of positive airway pressure (PAP) therapy (Yes/No)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as number of participants.

  16. Change in waist circumference

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as centimetre (cm).

  17. Change in neck circumference

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as cm.

  18. Change in systolic blood pressure (SBP)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as millimetre of mercury (mmHg).

  19. Change in diastolic blood pressure (DBP)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as mmHg.

  20. Change in high-sensitivity C-reactive protein (hsCRP)

    Time frame · From baseline (week 0) to (week 80)

    Registry description

    Measured as ratio to baseline.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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