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Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure (AMAZE 4)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520443-16-00
Enrollment
25
Registered
2026-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight or obesity, and obstructive sleep apnoea treated with positive airway preassure (PAP)

Brief summary

Relative change in body weight, Change in apnoea-hypopnoea index (AHI)

Detailed description

Relative change in AHI, Achievement of 50% reduction in AHI (Yes/No), Achievement of: AHI < 5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No), Change in sleep apnoea specific hypoxic burden (SASHB), Change in ESS score, Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score, Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score, Change in body weight, Change in body mass index (BMI), Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No) ≥ 5 and < 15/hour = mild (Yes/No) ≥ 15 and < 30/hour = moderate (Yes/No) ≥ 30/hour = severe (Yes/No), Withdrawal of positive airway pressure (PAP) therapy (Yes/No), Change in waist circumference, Change in neck circumference, Change in systolic blood pressure (SBP), Change in diastolic blood pressure (DBP), Change in high-sensitivity C-reactive protein (hsCRP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides, Change in fasting plasma glucose, Change in glycated haemoglobin (HbA1c), Number of: Treatment emergent adverse events (TEAEs) Treatment emergent serious adverse events (TESAEs) TEAEs leading to permanent treatment discontinuation

Interventions

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Relative change in body weight, Change in apnoea-hypopnoea index (AHI)

Secondary

MeasureTime frame
Relative change in AHI, Achievement of 50% reduction in AHI (Yes/No), Achievement of: AHI < 5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No), Change in sleep apnoea specific hypoxic burden (SASHB), Change in ESS score, Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score, Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score, Change in body weight, Change in body mass index (BMI), Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No) ≥ 5 and < 15/hour = mild (Yes/No) ≥ 15 and < 30/hour = moderate (Yes/No) ≥ 30/hour = severe (Yes/No), Withdrawal of positive airway pressure (PAP) therapy (Yes/No), Change in waist circumference, Change in neck circumference, Change in systolic blood pressure (SBP), Change in diastolic blood pressure (DBP), Change in high-sensitivity C-reactive protein (hsCRP), Change in lipids: Total cholesterol High-density lipoprotein

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 25, 2026