NNC0487-0111 / Obesity / Overweight · Phase 3 Trial

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

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

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

AI Summary

This is a Phase 3 randomized controlled trial registration investigating NNC0487-0111 (a novel agent) versus placebo in patients with obesity or overweight and obstructive sleep apnoea on positive airway pressure therapy. No results are currently reported; the study is recruiting and primary outcomes (relative body weight change and apnoea-hypopnoea index change at week 80) have not been assessed.

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. 92 sites across 10 countries.

Key findings

Safety

Efficacy and safety data cannot be assessed from registration alone

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 outcomes have not yet been reported.

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

Setting92 sites across 10 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment300

PhasePhase 3

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

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

Follow-up duration80 weeks

Caveats

This is a registry record; no results have been reported or analysed
Study is currently recruiting; outcomes are not yet available
Efficacy and safety data cannot be assessed from registration alone
Detailed eligibility criteria, dosing regimen specifics, and blinding methods not fully described in registry record

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 appropriate for efficacy assessment.

Directness

strong

Hard clinical endpoints: body weight change and apnoea-hypopnoea index in target population.

Consistency

insufficient

No results reported; consistency cannot be assessed at registration stage.

Risk of bias

insufficient

Randomization and blinding stated but conduct details and risk assessment unavailable.

Sample adequacy

moderate

Planned enrollment 300 participants; adequate for Phase 3 but recruitment ongoing.

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 (NCT07571109). 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 overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. 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.

NNC0487-0111ObesityOverweightNCT07571109Novo NordiskObstructive Sleep ApnoeaPlacebo (matched to NNC0487-0111)