A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity

What Was Tested

In this phase 1 trial, researchers set out to test Amycretin.

NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1).

Both hormones work like body's own hormones and help the body to feel full.

It had four arms (groups): one (experimental), one (experimental), Part C (experimental) and Part D (experimental).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 144 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female aged 18-55 years (both inclusive) at time of signing informed consent. Body mass index (BMI) of 25.0 to 34.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. 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. Male or female aged 18-55 years (both inclusive) at time of signing informed consent. Body mass index (BMI) of 27.0 to 39.9 kg/m\^2 (both inclusive) at screening.

The full record lists 6 inclusion and 16 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) less than 20 nanograms per milliliter (ng/ml) (50 nano molar (nm)) at screening.

How the Study Was Run

The set-up was randomized, sequential and quadruple-blind.

The participants were allocated by chance, so the Amycretin group and the comparison group should start out alike.

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 2022-05-11 with completion listed for 2024-01-09.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of treatment emergent adverse events (TEAE).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Amycretin in 144 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.