A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

Summary

This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.

Timeline

Start

2021-03-08

Primary completion

2022-09-15

Completion

2022-10-07

Publications

• Ekinci EI, Maldonado SG, Unseld A, Martinez JA, Hennige AM, Schoelch C. Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell Function and Insulin Sensitivity in People With Type 2 Diabetes or Living With Overweight/Obesity. Diabetes Obes Metab. 2026 Jun 22. doi: 10.1111/dom.70861. Online ahead of print.
• le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hussain SA, Hennige AM. Subgroup analysis by sex and baseline BMI in people with a BMI >/=27 kg/m2 in the phase 2 trial of survodutide, a glucagon/GLP-1 receptor dual agonist. Diabetes Obes Metab. 2025 Apr;27(4):1773-1782. doi: 10.1111/dom.16167. Epub 2025 Jan 16.
• le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hennige AM. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. Lancet Diabetes Endocrinol. 2024 Mar;12(3):162-173. doi: 10.1016/S2213-8587(23)00356-X. Epub 2024 Feb 5.

Drugs

Indications