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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
EU CTIS ID: 2024-520443-16-00
What this study is testing
1. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in body weight in participants with overweight or obesity, and obstructive sleep apnoea (OSA) on positive airway pressure (PAP) therapy 2. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in apnoea-hypopnoea index (AHI) in participants with overweight or obesity, and OSA on PAP therapy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female (sex at birth).
- 2. Age 18 years or above at the time of signing informed consent.
- 3. CCI
- 3. CCI
- 5. 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.
You likely can't join if
- 1. Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
- 2. History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
- 3. 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.
- 4. Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence.
- 5. 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 within CCI before screening.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- India
- Taiwan
- Turkey
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; India; Taiwan; Turkey; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.