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

What Was Tested

In this phase 3 trial, researchers set out to test Amycretin.

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.

It had two arms (groups): NNC0487-0111 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 300 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female (sex at birth). Age 18 years or above at the time of signing informed consent. Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records; 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Amycretin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Amycretin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-05-05 with completion listed for 2028-07-12.

It ran at 80 sites in United States (17), India (13), Poland (10), Spain (9), Turkey (Türkiye) (8) and Germany (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Relative change in body weight (time frame: From baseline (week 0) to (week 80)). Change in apnoea-hypopnoea index (AHI) (time frame: From baseline (week 0) to (week 80)).

It also tracked 30 secondary outcomes, for example Relative change in AHI, Achievement of: AHI less than (<) 5, Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No), Change in sleep apnoea specific hypoxic burden (SASHB), Change in ESS score and Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Amycretin in 300 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amycretin compound page, all human trials.