COMBINATION_PRODUCT
Survodutide
Survodutide, pre-filled syringe
Status
Completed
Phase
Phase 1
Enrollment
34
Locations
1
Results
Not posted
Publications
0
Study 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 purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of bupropion, caffeine, and midazolam in the blood. The study has 2 treatment periods. In Period 1, participants take 1 dose each of midazolam, caffeine, and bupropion as tablets or oral solution on separate days. In Period 2, participants get BI 456906 as an injection under the skin once a week. At 2 selected timepoints in Period 2, participants also take midazolam, caffeine and bupropion as tablets or oral solution on separate days. Participants are in the study for about 13 months. They visit the study site up to 45 times. At 3 of those visits, participants stay for 5 or 6 days at the study site. During the visits, doctors collect information about participants' health and take blood samples from the participants. They compare the amounts of midazolam, caffeine, and bupropion in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.
Interventions
COMBINATION_PRODUCT
Survodutide, pre-filled syringe
DRUG
Bupropion
DRUG
Caffeine
DRUG
Midazolam
Timeline
First posted
Aug 21, 2024
Study start
Oct 1, 2024
Primary completion
Dec 16, 2025
Study completion
Jan 5, 2026
Results posted
Not reported
Registry updated
Mar 13, 2026
Outcomes
Area under the concentration-time curve of bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)
Time frame · Up to week 32
Area under the concentration-time curve of the caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)
Time frame · Up to week 32
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)
Time frame · Up to week 32
Maximum measured concentration of bupropion in plasma (Cmax)
Time frame · Up to week 32
Maximum measured concentration of caffeine in plasma (Cmax)
Time frame · Up to week 32
Maximum measured concentration of midazolam in plasma (Cmax)
Time frame · Up to week 32
Not reported in the indexed record.
Eligibility
Inclusion Criteria : 1. 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 2. Age of 18 to 60 years (inclusive) at signing of informed consent 3. Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive) and body weight \> 70 kg 4. 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 5. Further inclusion criteria apply Exclusion Criteria : 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator. 2. 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) 3. 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. 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Further exclusion criteria apply
Study locations
Belgium. Showing up to 24 locations stored in the fast local snapshot.
SGS Life Science Services - Clinical Research
Edegem, Belgium
Publications
No PMID-linked publications were present in this registry snapshot.
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