A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver

What Was Tested

This registered phase 1 trial tested Semaglutide and Survodutide.

This study is open to adults with obesity.

People with a body mass index (BMI) in the range from 30 to 40 kg/m2 and a body weight of 70 to 150 kg can participate in the study.

The purpose of this study is to find out whether treatment with a medicine called BI 456906 changes the occupancy of receptors in the liver and in the pancreas.

It had four arms (groups): Group 1: BI 456906 (experimental), Group 2: Semaglutide (experimental), Group 3: BI 456906 (active comparator) and Group 4: Semaglutide (active comparator).

PET/CT imaging for analysis of the liver.

PET/CT imaging for analysis of the liver.

PET/CT imaging for analysis of the pancreas.

The registry classes the interventions as drug.

Who Took Part

The registry lists 29 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Age of 18 to 65 years (inclusive). Body mass index (BMI) of ≥ 30 and ≤ 40 kg/m2 and body weight ≥70 kg and ≤150 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 12 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; gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator; diseases of the central nervous system (including but not limited to any kind of seizures), and other relevant neurological or psychiatric disorders.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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

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

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

Those kept unaware of assignments: outcomes assessor.

It started in 2024-11-01 with completion listed for 2027-01-06.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of glucagon (GCG) receptors occupancy in the liver using Positron emission tomography (PET) imaging at End of Treatment (EOT) visit (time frame: up to Week 17).

It also tracked 1 secondary outcome, for example Percentage of glucagon-like Peptide 1 (GLP-1) receptors occupancy in the pancreas using PET imaging at EOT visit.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide and Survodutide in 29 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; 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.