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
| NCT ID | NCT07571109 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novo Nordisk A/S |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-05-05 |
| Primary Completion | 2028-06-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2026-05-05 with a primary completion date of 2028-06-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Clinical Transparency dept. 2834
STUDY DIRECTOR
Novo Nordisk A/S
Frequently Asked Questions
Who can join the NCT07571109 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07571109 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT07571109 currently recruiting?
Yes, NCT07571109 is actively recruiting participants. Contact the research team at clinicaltrials@novonordisk.com for enrollment information.
Where is the NCT07571109 trial being conducted?
This trial is being conducted at Gilbert, United States, Bradenton, United States, Naples, United States, West Palm Beach, United States and 11 additional locations.
Who is sponsoring the NCT07571109 clinical trial?
NCT07571109 is sponsored by Novo Nordisk A/S. The principal investigator is Clinical Transparency dept. 2834 at Novo Nordisk A/S. The trial plans to enroll 300 participants.
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