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AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss

Plain-language guide to NCT07503210: phase 3 randomized trial of Amycretin, fat loss, obesity & body recomposition, 606 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07503210
Phase
phase 3
Status
active, not recruiting
Start
2026-04-21
Completion (planned or actual)
2028-06-06
Participants
606 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Amycretin for fat loss, obesity & body recomposition.

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

606 actual participants took part.

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 the informed consent.

The full record lists 2 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

Design: 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.

Neither the fat loss, obesity & body recomposition participants nor the staff measuring them knew who was on Amycretin, so expectations could not easily colour the readings.

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

It started in 2026-04-21 with completion listed for 2028-06-06.

It ran at 72 sites in United States (13), Bulgaria (8), Italy (8), Germany (7), Spain (7) and France (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Relative change in body weight (time frame: From week 40 to week 92).

It also tracked 42 secondary outcomes, for example Relative change in body weight, 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 and Change in body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Amycretin in 606 people with fat loss, obesity & body recomposition.

With 606 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amycretin compound page, Fat loss, obesity & body recomposition research.

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.