A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906

What Was Tested

This registered phase 1 trial tested Semaglutide and Survodutide.

This study is open to adults between 18 and 55 years of age who are living with overweight or obesity.

People with a body mass index (BMI) from 27 to 40 kg/m2 can join the study.

The main purpose of this study is to find out how a medicine called BI 1820237 is tolerated by people with overweight or obesity when taken alone or in combination with a medicine called semaglutide or with a medicine called BI 456906.

It had six arms (groups): BI 1820237 treatment group (experimental), Placebo group (placebo comparator), BI 1820237 + semaglutide treatment group (experimental), placebo + semaglutide group (active comparator) and BI 1820237 + BI 456906 treatment group (experimental).

The registry classes the interventions as drug.

Who Took Part

88 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Age of 18 to 55 years (inclusive). Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive). Overweight/obesity should be due to excess adipose tissue, as judged by the Investigator. Body weight greater than or equal to 75 kg. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Further inclusion criteria apply.

The full record lists 6 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.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

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

Those kept unaware of assignments: participant.

It started in 2023-04-11 with completion listed for 2024-08-01.

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 treatment-emergent adverse events (time frame: Up to 180 days).

It also tracked 2 secondary outcomes, for example Maximum measured concentration of BI 1820237 in plasma (Cmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide and Survodutide in 88 people.

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

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