A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood

What Was Tested

This registered phase 1 trial tested Survodutide.

This study is open to women with overweight or obesity who are otherwise healthy.

Women with a body mass index (BMI) from 27 to 40 kg/m2 can participate.

It had 1 arm (groups): Microgynon® (Reference treatment (R)) followed by BI 456906 and Microgynon® (Test treatment (T)) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 32 actual participants took part.

It was open to women only aged from 18 years up to 60 years.

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

Examples of who could join: Age of 18 to 60 years (inclusive). Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive). Subject fulfills any of the following criteria at least 4 weeks prior to allocation of subject number (i.e. prior to Day 1 of period 1):. Bilateral tubal ligation and male partner must be vasectomised (provided that partner is the sole sexual partner of the trial participant) with documented absence of sperm or use a condom. Sexually abstinent (i.e. subjects must abstain from male-female sex).

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator; any evidence of a concomitant disease assessed as clinically relevant by the investigator; gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Survodutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-12-21 with completion listed for 2025-02-14.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) (time frame: up to Week 29). Maximum measured concentration of ethinylestradiol in plasma (Cmax) (time frame: up to Week 29). Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) (time frame: up to Week 29).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Survodutide in 32 people.

Its size is small, so on its own it can only give an early look.

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

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