AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

What Was Tested

This registered phase 3 trial tested Semaglutide and Amycretin.

Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week.

The placebo is a treatment with no active medicine in it and will be given to all participants.

It had two arms (groups): NNC0487-0111 (experimental) and Semaglutide (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1000 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.

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

Design: randomized, parallel-group and quadruple-blind.

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

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

As a double-blind Semaglutide 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 2026-05-20 with completion listed for 2028-12-12.

It ran at 120 sites in Poland (20), India (18), Bulgaria (11), United States (10), Germany (10) and Croatia (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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 body weight, Change in body mass index (BMI), Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no) and Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Amycretin in 1000 people.

With 1000 participants it is a large trial for this field.

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

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