DRUG
NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
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
Enrollment
300
Locations
92
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Placebo (matched to NNC0487-0111)
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.
Timeline
From registration to results.
First posted
May 6, 2026
Study start
May 5, 2026
Primary completion
Jun 26, 2028
Study completion
Aug 21, 2028
Results posted
Not reported
Registry updated
Jul 13, 2026
Outcomes
What the study measures.
Primary outcomes
Relative change in body weight
Time frame · From baseline (week 0) to (week 80)
Measured as percentage (%) change in body weight.
Change in apnoea-hypopnoea index (AHI)
Time frame · From baseline (week 0) to (week 80)
Measured as events/hour.
Secondary outcomes
Relative change in AHI
Time frame · From baseline (week 0) to (week 80)
Measured as percentage change in AHI.
Achievement of 50% reduction in AHI (Yes/No)
Time frame · From baseline (week 0) to (week 80)
Measured as number of participant.
Achievement of: AHI less than (<) 5
Time frame · From baseline (week 0) to (week 80)
Measured as number of participants.
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.
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).
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.
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.
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.
Change in body weight
Time frame · From baseline (week 0) to (week 80)
Measured as kilogram (Kg).
Change in body mass index (BMI)
Time frame · From baseline (week 0) to (week 80)
Measured as kilograms per meter square (kg/m\^2).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
92 registered sites.
Australia · China · Germany · India · Japan · Poland · Spain · Taiwan · Turkey (Türkiye) · United States. Showing up to 24 locations stored in the fast local snapshot.
Dignity Health, Mercy Gilbert
Gilbert, Arizona, United States
DM Clinical
Bradenton, Florida, United States
Essence MD Research
Naples, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Physicians Research Associates
Lawrenceville, Georgia, United States
Chicago Research Center, Inc
Chicago, Illinois, United States
Weil Cornell Medicine
New York, New York, United States
Lillestol Research LLC
Fargo, North Dakota, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Clinical Research Associates of Central PA, LLC
DuBois, Pennsylvania, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
Epic Medical Research
DeSoto, Texas, United States
Advanced Neurology Epilepsy and Sleep Center ANESC
El Paso, Texas, United States
Biorhythms Center for Integrative Sleep Medicine
El Paso, Texas, United States
Houston Pulmonary Medicine Associates, PA and Research Physicians Network, LLC
Houston, Texas, United States
Sleep Therapy Research Center
San Antonio, Texas, United States
Tricoastal Sleep Center
Sugar Land, Texas, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Seattle Clinical Research Center
Seattle, Washington, United States
Woolcock Institute
Macquarie Park, New South Wales, Australia
University of Sunshine Coast - Vitality Village
Birtinya, Queensland, Australia
Mater Research - RIO Clinical Trials Unit
South Brisbane, Queensland, Australia
Nightingale Research
Adelaide, South Australia, Australia
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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