A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin

What Was Tested

The trial (phase 2) is built around Amycretin.

It had two arms (groups): NNC0487-0111 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 125 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female. Aged 18-55 years (both inclusive) at the time of signing informed consent. Body Mass Index (BMI) between 27.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol; any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:; vitamin d (25-hydroxycholecalciferol) below 12 ng/ml (30 nm) at screening.

How the Study Was Run

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

Because people in this Amycretin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2023-09-15 with completion listed for 2024-11-27.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: PART A: Number of treatment emergent adverse events (TEAE). PARTS B to E: Number of treatment emergent adverse events (TEAE).

It also tracked 5 secondary outcomes, for example PART B to E: Relative change in body weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amycretin in 125 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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