NCT06564441CompletedPhase 1
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
An Open-label, Non-randomised, Fixed-sequence, Two Period, Phase I Trial to Evaluate the Effect of Different Doses of BI 456906 (Survodutide) on the Single Dose Pharmacokinetics of Bupropion, Caffeine and Midazolam on Otherwise Healthy Volunteers With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 20 Aug 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 16 Dec 2025
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Obesity
- NCT number
- NCT06564441
- EU CT number
- 2024-512332-29-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 34
- From 1 Oct 2024 to the primary completion date, 16 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Lab values
- 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.
Other
- 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)
- Further exclusion criteria apply
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SGS Belgium Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.