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NCT Number: 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

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.

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Key information

Conditions

Obesity Apnea Body Weight Dyssomnias Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obstructive Sleep Apnoea Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Woolcock Institute, Macquarie Park, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC0487-0111

Drug

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Placebo (matched to NNC0487-0111)

Drug

Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Primary outcomes

  1. Relative change in body weight

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

    Measured as percentage (%) change in body weight.

  2. Change in apnoea-hypopnoea index (AHI)

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

    Measured as events/hour.

Secondary outcomes

  1. Relative change in AHI

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

    Measured as percentage change in AHI.

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

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

    Measured as number of participant.

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

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

    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)

    Measured as number of participants.

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

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

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

  6. Change in ESS score

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

    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)

    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)

    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)

    Measured as kilogram (Kg).

  10. Change in body mass index (BMI)

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

    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)

    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)

    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)

    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)

    Measured as number of participants.

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

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

    Measured as number of participants.

  16. Change in waist circumference

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

    Measured as centimetre (cm).

  17. Change in neck circumference

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

    Measured as cm.

  18. Change in systolic blood pressure (SBP)

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

    Measured as millimetre of mercury (mmHg).

  19. Change in diastolic blood pressure (DBP)

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

    Measured as mmHg.

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

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

    Measured as ratio to baseline.

  21. Change in Total cholesterol

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

    Measured as ratio to baseline.

  22. Change in High-density lipoprotein (HDL) cholesterol

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

    Measured as ratio to baseline.

  23. Change in Low-density lipoprotein (LDL) cholesterol

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

    Measured as ratio to baseline.

  24. Change in Very low-density lipoprotein (VLDL) cholesterol

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

    Measured as ratio to baseline.

  25. Change in Non-HDL cholesterol

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

    Measured as ratio to baseline.

  26. Change in Triglycerides

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

    Measured as ratio to baseline.

  27. Change in fasting plasma glucose

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

    Measured as millimoles per litre (mmol/L).

  28. Change in glycated haemoglobin (HbA1c)

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

    Measured as percentage (%) of HbA1c.

  29. Number of Treatment emergent adverse events (TEAEs)

    Time frame: From baseline (week 0) to week 84

    Measured as events.

  30. Number of Treatment emergent serious adverse events (TESAEs)

    Time frame: From baseline (week 0) to week 84

    Measured as Events.

  31. Number of TEAEs leading to permanent treatment discontinuation

    Time frame: From baseline (week 0) to week 84

    Measured as events.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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)

Acronym: AMAZE 4

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 6, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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