A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant

What Was Tested

This registered phase 1 trial tested Amycretin.

Participants will take 1-tablet once daily.

It had 1 arm (groups): NNC0487-0111 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 43 actual participants took part.

It was open to women only aged from 18 years up to 65 years.

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

Examples of who could join: Females of non-childbearing potential. Age 18 - 65 years (both inclusive) at the time of signing the informed consent. Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol; any contraindications for the use of the oral contraception used in the study according to the microgynon product information.

How the Study Was Run

It was run as a sequential and open-label study.

Nothing was hidden in this open-label Amycretin study: the participants and staff both knew the treatment.

It started in 2024-06-14 with completion listed for 2025-03-16.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The area under the ethinylestradiol plasma concentration time curve at steady state (time frame: Day 8 and Day 193). The area under the levonorgestrel plasma concentration time curve at steady state (time frame: Day 8 and Day 193).

It also tracked 12 secondary outcomes, for example Maximum ethinylestradiol plasma concentration at steady state, Maximum levonorgestrel plasma concentration at steady state, The area under the ethinylestradiol plasma concentration time curve at steady state, The area under the levonorgestrel plasma concentration time curve at steady state, Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state and Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Amycretin in 43 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.