A Study in Men With Overweight to Test How Well Different Doses of BI 1820237 Are Tolerated When Given as an Injection Alone or in Combination With Liraglutide

What Was Tested

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

It had four arms (groups): BI 1820237 (experimental), Placebo (placebo comparator), BI 1820237 + liraglutide (experimental) and Placebo + liraglutide (placebo comparator).

Part 1 and part 2 of the trial.

Part 1 and part 2 of the trial.

Part 3 of the trial.

The registry classes the interventions as drug.

Who Took Part

95 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: Age of 18 to 50 years (inclusive). Body mass index (BMI) of 25.0 to 34.9 kg/m2 (inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator. Body weight greater than or equal to 70 kg. Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.

The full record lists 5 inclusion and 8 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 laboratory value outside the reference range that the investigator considers to be of clinical relevance; any evidence of a concomitant disease assessed as clinically relevant by the investigator.

How the Study Was Run

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

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

The Liraglutide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant.

It started in 2021-06-08 with completion listed for 2022-08-26.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of subjects with drug-related adverse events (time frame: up to 48 days).

It also tracked 2 secondary outcomes, for example Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and Maximum measured concentration of the analyte in plasma (Cmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 95 people.

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

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