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A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body of Participants Living With Overweight or Obesity

Plain-language guide to NCT06478563: phase 1 randomized trial of Amycretin, 133 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06478563
Phase
phase 1
Status
completed
Start
2024-06-27
Completion (planned or actual)
2025-06-05
Participants
133 (actual)
Design
randomized, single-blind, treatment
Conditions studied
Obesity; Overweight
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

This study consists of two phases: Phase A and Phase B.

Participants are being asked to participate in both phases.

Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity.

It had four arms (groups): Phase A: NNC0487-0111 (formulation D) (experimental), Phase A: NNC0487-0111 (formulation C) (active comparator), Phase B: NNC0487-0111 (formulation D) (experimental) and Phase B: NNC0487-0111 (formulation C) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 133 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female. Age 18-64 years (both inclusive). Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m\^2) (both inclusive).

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) less than (\<) 12 ng/ml (30 nanometer (nm)) at screening.

How the Study Was Run

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

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.

Only one side, usually the participants, was kept unaware of whether Amycretin was given.

Those kept unaware of assignments: investigator.

It started in 2024-06-27 with completion listed for 2025-06-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state, Phase B: The area under the NNC0487-0111 plasma concentration-time curve and 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 133 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.

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.