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AMAZE 3
NCT07571005Phase 3
Key facts
- Status
- Recruiting
- Start
- May 2026
- Primary completion
- Jul 2028
- Countries
- 10
- Sponsor
- Novo Nordisk
- Modality
- Peptides, Small Molecules
- Drugs
- amycretin
- Conditions
- obesityobstructive sleep apnea (OSA)
01
Overview
Phase 3, randomised, double-blind trial in obesity and obstructive sleep apnea (OSA) comparing NNC0487-0111 with Placebo (2 arms). Primary endpoints: Relative change in body weight at 80 weeks and Change in apnoea-hypopnoea index at 80 weeks. Started May 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
NNC0487-0111
NNC0487-0111 subcutaneously once weekly
Placebo
Placebo matched to NNC0487-0111 subcutaneously once weekly
03
Who it enrols
Adults with overweight or obesity and moderate-to-severe obstructive sleep apnoea (AHI >= 15) not treated with positive airway pressure. Excludes patients with diabetes, HbA1c >= 6.5%, recent sleep apnoea surgery, significant craniofacial abnormalities, or prior treatment with GLP-1/GIP or amylin analogues.
04
Endpoints
Primary
Relative change in body weight
Change in apnoea-hypopnoea index
Secondary
Relative change in apnoea-hypopnoea index
Achievement of 50% reduction in AHI
Achievement of AHI less than 5
Achievement of AHI 5-14 with Epworth Sleepiness Scale <= 10
Change in sleep apnoea specific hypoxic burden
Change in Epworth Sleepiness Scale
Change in Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep-Related Impairment 8a
Change in Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance 8b
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