A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity

What Was Tested

This registered phase 1 trial tested Survodutide.

The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity.

It had four arms (groups): A-B-C-D (experimental), B-D-A-C (experimental), C-A-D-B (experimental) and D-C-B-A (experimental).

* A: Treatment Test 1 (T1): BI 1820237 + Placebo for BI 456906 * B: Treatment Test 2 (T2): BI 456906 + Placebo for BI 1820237 * C: Treatment Test 3 (T3): BI 1820237 + BI 456906 * D: Treatment Reference (R1, R2): Placebo for BI 1820237 + Placebo for BI 456906.

The registry classes the interventions as drug.

Who Took Part

23 actual participants took part.

It was open to people of any sex aged from 40 years up to 60 years.

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

Examples of who could join: Age of 40 to 60 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. Male trial participants without need for contraception.

The full record lists 13 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.

How the Study Was Run

Design: randomized, crossover and single-blind.

The participants were allocated by chance, so the Survodutide group and the comparison group should start out alike.

Each person switched between Survodutide and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant.

It started in 2024-04-30 with completion listed for 2025-02-24.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Survodutide in 23 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.