A Study to Test How Different Doses of BI 456906 Are Tolerated in Japanese Men With a Body Mass Index (BMI) Between 23 and 40 kg/m2

What Was Tested

This registered phase 1 trial tested Survodutide.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo group (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

37 actual participants took part.

It was open to men only aged from 20 years up to 45 years.

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

Examples of who could join: Japanese ethnicity, according to the following criteria:. Age of 20 to 45 years (inclusive) at screening visit. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration. Vasectomized (vasectomy at least 1 year prior to enrolment).

The full record lists 10 inclusion and 23 exclusion criteria; among the exclusions: any evidence of a concomitant disease, baseline condition, or medical history assessed as clinically relevant by the investigator including:; repeated measurement of supine blood pressure (bp) ≥160/95 mmhg, or pulse rate (pr) \>90 bpm after 5 minutes of resting at screening visit; renal artery stenosis or evidence of labile blood pressure including symptomatic hypotension, or history of relevant orthostatic hypotension, fainting spells, or blackouts.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Survodutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2020-06-01 with completion listed for 2020-11-17.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example AUC0-168 (area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to 168h).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Survodutide in 37 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.