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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.