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

Korábbi kezelés

• 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)

Más betegség

• 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

Laborértékek

• 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.

• 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))