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
Novo Nordisk A/S · NCT07571109
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 300
- US sites recruiting
- 19
- Study start
- May 5, 2026
- Record last updated
- October 7, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: NNC0487-0111; Placebo (matched to NNC0487-0111)
Conditions: Obesity; Overweight; Obstructive Sleep Apnoea
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Dignity Health, Mercy Gilbert
Gilbert, AZ 85297
DM Clinical
Bradenton, FL 34209
Essence MD Research
Naples, FL 34102
Palm Beach Research Center
West Palm Beach, FL 33409
NeuroTrials Research, Inc.
Atlanta, GA 30328
Physicians Research Associates
Lawrenceville, GA 30046
Chicago Research Center, Inc
Chicago, IL 60634
Weil Cornell Medicine
New York, NY 10021
Lillestol Research LLC
Fargo, ND 58104
CTI Clinical Research Center
Cincinnati, OH 45212
Bogan Sleep Consultants, LLC
Columbia, SC 29201
Epic Medical Research
DeSoto, TX 75115
Advanced Neurology Epilepsy and Sleep Center ANESC
El Paso, TX 79912
Biorhythms Center for Integrative Sleep Medicine
El Paso, TX 79912
Houston Pulm Med Res Network
Houston, TX 77089
Sleep Therapy Research Center
San Antonio, TX 78229
Tricoastal Sleep Center
Sugar Land, TX 77478
Rainier Clin Res Ctr Inc
Renton, WA 98057
Seattle Clinical Research Center
Seattle, WA 98104
Study contacts (from the official record)
- Novo Nordisk · (+1) 866-867-7178 · clinicaltrials@novonordisk.com
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