Status:
COMPLETED
A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study is open to adults with overweight or obesity who are otherwise healthy. People can join the study if they have a body mass index of 27 to 39.9 kg/m2 and a body weight over 70 kg. The purpos...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Otherwise healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 60 years (inclusive) at signing of informed consent
- Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive) and body weight \> 70 kg
- Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial, i.e. prior to starting any screening procedures legislation prior to admission to the trial, i.e. prior to starting any screening procedures
- Further inclusion criteria apply
- Exclusion Criteria :
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and in particular:
- Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%,
- Aspartate aminotransferase (AST) above ULN + 20%,
- Gamma-Glutamyl-Transferase (GGT) above ULN + 20%,
- Lipase or amylase above ULN + 20%,
- Estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m².
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Further exclusion criteria apply
Exclusion
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06564441
Start Date
October 1 2024
End Date
January 5 2026
Last Update
January 9 2026
Active Locations (1)
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1
SGS Life Science Services - Clinical Research
Edegem, Belgium, 2650