NNC0487-0111 / Obesity / Overweight · Phase 3 Trial

AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is an active Phase 3 randomized controlled trial of NNC0487-0111 versus placebo for weight loss and obstructive sleep apnoea in people not using positive airway pressure. No results have been posted to the registry; the study is currently recruiting and outcomes will not be known until trial completion and publication.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Obesity, Overweight, Obstructive Sleep Apnoea; age from 18 Years. Intervention: NNC0487-0111. Compared with: Placebo — Placebo Comparator. n = 300. 80 sites across 10 countries.

Key findings

Safety

This is a registry record only; no efficacy or safety results have been reported

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 trial registration with no results posted; the study is actively recruiting and has not yet reported efficacy or safety outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Relative change in body weight (assessed at From baseline (week 0) to (week 80)); Change in apnoea-hypopnoea index (AHI) (assessed at From baseline (week 0) to (week 80))

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationObesity, Overweight, Obstructive Sleep Apnoea; age from 18 Years

Sample size300

InterventionNNC0487-0111

ComparatorPlacebo — Placebo Comparator

Setting80 sites across 10 countries

Reported figures

Quoted from the source exactly as published.

Study phasePHASE 3

Planned enrollment300

Primary outcome measure 1Relative change in body weight from baseline (week 0) to week 80

Primary outcome measure 2Change in apnoea-hypopnoea index (AHI) from baseline (week 0) to week 80

Recruitment statusRECRUITING

Caveats

This is a registry record only; no efficacy or safety results have been reported
Study is actively recruiting; data collection and analysis are incomplete
Planned enrollment is estimated at 300 but may differ from actual enrollment
No interim or final results are available; clinicians must await peer-reviewed publication

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3, randomized, placebo-controlled, interventional design

Directness

strong

Addresses clinical efficacy in obesity and obstructive sleep apnoea directly

Consistency

insufficient

No results yet reported; consistency cannot be assessed from registry record

Risk of bias

insufficient

No methods detail provided; randomization and blinding noted but full conduct unclear

Sample adequacy

moderate

Planned enrollment 300 participants; adequate for Phase 3 but not yet accrued

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07571005). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Obesity, Overweight, Obstructive Sleep Apnoea. Interventions: DRUG: NNC0487-0111; DRUG: Placebo (matched to NNC0487-0111). Primary outcome measures: Relative change in body weight , From baseline (week 0) to (week 80); Change in apnoea-hypopnoea index (AHI) , From baseline (week 0) to (week 80). Brief summary: This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NNC0487-0111ObesityNCT07571005OverweightNovo NordiskObstructive Sleep ApnoeaPlacebo (matched to NNC0487-0111)