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AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight

Plain-language guide to NCT07339423: phase 3 randomized trial of Amycretin, 1150 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07339423
Phase
phase 3
Status
recruiting participants
Start
2026-02-24
Completion (planned or actual)
2029-06-26
Participants
1150 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

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).

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 1150 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). Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 3 inclusion and 3 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 agonists (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

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Amycretin and who got the comparison, which limits bias.

The Amycretin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Amycretin.

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

It started in 2026-02-24 with completion listed for 2029-06-26.

It ran at 72 sites in United States (22), United Kingdom (12), Argentina (6), Belgium (6), Denmark (6) 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 84).

It also tracked 24 secondary outcomes, for example Change in waist circumference, Change in systolic blood pressure (SBP), Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score, Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score, Change in body weight and Change in body mass index (BMI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Amycretin in 1150 people.

With 1150 participants it is a large trial for this field.

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.

Our Notes on the Compound

Amycretin: A single molecule that activates both GLP-1 and amylin receptors, tested by injection and as a tablet in early obesity trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.