A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity

Launched by BOEHRINGER INGELHEIM · Dec 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called survodutide to see if it helps people with obesity use energy more effectively and break down fat better. The trial is open to adults aged 18 to 65 who have a body mass index (BMI) between 30 and 45, which means they have obesity. Participants will be randomly assigned to receive either survodutide or a well-known medication called semaglutide, which is already used to help with weight loss. Both medications are given as an injection under the skin once a week, and the study lasts about 8 to 10 months.

During the trial, participants will visit the study site weekly, where doctors will monitor their health and check for any side effects. Some visits may also happen at home. Participants will take part in tests to measure how much energy their bodies use, which involves measuring the oxygen they breathe in and the carbon dioxide they breathe out. This information will help researchers understand if survodutide works better than semaglutide. It's important for participants to be motivated and able to follow the study procedures, including learning how to give themselves the injections.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • Age of 18 to 65 years (inclusive)
• • Male or female subjects with obesity (defined as a body mass index (BMI) of ≥30 and ≤45 kg/m²)
• • Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
• • Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• * In the investigator's opinion, are well-motivated, capable, and willing to:
• • Learn how to self-inject the investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP)
• • Inject the IMP or accept injection from a designated person --- Follow trial procedures for the duration of the trial, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise, maintain a diary, complete required questionnaires, and handle the IMP as described in the instruction for use (IFU))
• Exclusion criteria:
• • Current or history of significant alcohol consumption (defined as intake of \>210 g/week in men and \>140 g/week in women on average over a consecutive period of more than 3 months) or are unwilling to stop alcohol consumption 48 h before admission to the research facility and until discharge
• • History of chronic liver disease / cirrhosis
• • Body weight variation (self-reported) \>5% within 3 months before Visit 1 (screening)
• • Medications for obesity (including over-the-counter medications) within 3 months before Visit 1 (screening)
• • Glycated haemoglobin (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the local laboratory at screening
• • History of type 1 diabetes mellitus (T1DM) or T2DM or treatment with glucose lowering agent started within 3 months before Visit 1 (screening) Further exclusion criteria apply.