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AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Plain-language guide to NCT07533175: phase 3 randomized trial of Amycretin, 630 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07533175
Phase
phase 3
Status
recruiting participants
Start
2026-04-13
Completion (planned or actual)
2028-08-07
Participants
630 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Diabetes Mellitus; Overweight; 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 (treatment that has no active medicine in it).

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 630 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. Diagnosed with type 2 diabetes mellitus more than equal to (≥) 180 days before screening.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: known hypoglycaemic unawareness as indicated by the investigator according to clarke's questionnaire question 8; recurrent severe hypoglycaemic episodes within the last year as judged by the investigator; 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

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.

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

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 2026-04-13 with completion listed for 2028-08-07.

It ran at 74 sites in United States (15), Romania (9), Croatia (8), Hungary (8), Slovakia (7) and South Korea (7).

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 28 secondary outcomes, for example Change in waist circumference, Change in glycated haemoglobin (HbA1c), 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 630 people.

With 630 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.