NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Obesity, Overweight, Obstructive sleep apnoea
Date of first enrollment	20/05/2026
Target sample size	30
Countries of recruitment	Australia,Japan,China,Japan,Germany,Japan,India,Japan,Poland,Japan,Spain,Japan,Taiwan (Province of China),Japan,Turkiye,Japan,United States of America,Japan
Study type	Interventional
Intervention(s)	NNC0487-0111 or placebo s.c. once-weekly

Outcome(s)

Primary Outcome	1. Relative change in body weight from baseline (week 0) to week 80. 2. Change in apnoea-hypopnoea index (AHI) from baseline (week 0) to (week 80).
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Male or female (sex at birth) 2. Age 18 years or above at the time of signing informed consent 3. Previously diagnosed moderate-to-severe obstructive sleep apnoea (OSA) with an AHI >= 15 events/hour, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening.
Exclude criteria	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 mellitusa. 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 before screening.