A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906

What Was Tested

The trial (phase 1) is built around Survodutide.

This study is open to adults who have different levels of liver problems and adults who are healthy.

People with or without overweight or obesity can take part.

This study has 2 parts.

It had seven arms (groups): Part A: BI 456906: Cohort 1 (experimental), Part A: BI 456906: Cohort 2 (experimental), Part A: BI 456906: Cohort 3 (experimental), Part A: BI 456906: Cohort 4 (experimental) and Part B: BI456906: Cohort 1 (experimental).

Healthy subjects.

Patients with cirrhosis + Child-Turcotte-Pugh (CTP) Class A.

Patients with cirrhosis + CTP Class B.

The registry classes the interventions as drug.

Who Took Part

The registry lists 82 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female subjects with age ≥18 years (or the minimum country specific age of consent if \>18 years) and 75 years, inclusive at the screening visit. Body mass index (BMI) of 18.5-40.0 kg/m2 (inclusive). Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Male or female subjects between the ages of ≥18 (or the minimum country specific age of consent if \>18 years) and 75 years, inclusive, at the screening visit. Subjects with overweight or obesity, defined as BMI ≥27 kg/m2 at the screening visit.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: part a:; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at screening; part b:.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

Everyone knew when Survodutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-04-27 with completion listed for 2023-12-29.

It ran at 13 sites in United States (5), Germany (3), Hungary (2), New Zealand (1), Poland (1) and Slovakia (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: Up to 360 hours). Part A: Maximum measured concentration of BI 456906 in plasma (Cmax) (time frame: Up to 360 hours). Part B: Percentage of patients treated who experience treatment-emergent adverse event (time frame: Up to Day 218).

It also tracked 1 secondary outcome, for example Part A: Percentage of patients treated who experience treatment-emergent adverse event.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Survodutide in 82 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.