A Study to Test Different Doses of BI 456906 in Patients With Obesity

What Was Tested

This registered phase 1 trial tested Survodutide.

Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.

It had two arms (groups): BI 456906 (experimental) and Placebo (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 131 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Male and female patients ≥ 18 years and \< 70 years of age at screening. Body Mass Index (BMI) ≥ 27 kg/m2 and \<40 kg/m2 at screening. Further inclusion criteria apply.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: women who are pregnant, nursing, or who plan to become pregnant while in the trial; supine blood pressure (bp) ≥160/100 mmhg at screening; major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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

As a double-blind Survodutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2018-07-26 with completion listed for 2020-04-20.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme (time frame: Up to 132 days).

It also tracked 2 secondary outcomes, for example AUC0-168 (area under the concentration-time curve of the analyte 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 131 people.

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.