OverweightPhase 1NCT06564441
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
A Phase 1 study testing Survodutide, Bupropion and Caffeine in people with Overweight and Obesity, run by Boehringer Ingelheim at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Survodutide, Bupropion and Caffeine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2024to 5 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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%,
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Overweight, Obesity
- Being tested
- Survodutide, Bupropion, Caffeine, Midazolam
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurvodutideCombination product
Also called BI 456906
Survodutide, pre-filled syringe
BupropionDrug
Also called Wellbutrin® XR
Bupropion
CaffeineDrug
Also called Coffeinum® N
Caffeine
MidazolamDrug
Also called Midazolam Accord®
Midazolam
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | In Period 1: Bupropion, Caffeine, Midazolam are given as a reference treatment. In Period 2: Survodutide, Bupropion, Caffeine, Midazolam are given as a test treatment. Receives: Combination Product: Survodutide; Drug: Bupropion; Drug: Caffeine; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)
Measured: 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-∞)
Measured: 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-∞)
Measured: Up to week 32
Maximum measured concentration of bupropion in plasma (Cmax)
Measured: Up to week 32
Maximum measured concentration of caffeine in plasma (Cmax)
Measured: Up to week 32
Maximum measured concentration of midazolam in plasma (Cmax)
Measured: Up to week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Oct 2024
- Primary completion16 Dec 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The trial consists of two periods in a fixed sequence: period 1 (reference treatment) followed by period 2 (test treatment) within the BI 456906 titration scheme.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564441
- Sponsor's protocol ID
- 1404-0008
- Other IDs
- 2024-512332-29-00, U1111-1307-0132
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06564441
- Acronym / sponsor ID
- 1404-0008
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The trial consists of two periods in a fixed sequence: period 1 (reference treatment) followed by period 2 (test treatment) within the BI 456906 titration scheme.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Combination Product: Survodutide, Drug: Bupropion, Drug: Caffeine, Drug: MidazolamIn Period 1: Bupropion, Caffeine, Midazolam are given as a reference treatment. In Period 2: Survodutide, Bupropion, Caffeine, Midazolam are given as a test treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Further exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurvodutideAlso: BI 456906Survodutide, pre-filled syringe | Combination product | All participants |
| BupropionAlso: Wellbutrin® XRBupropion | Drug | All participants |
| CaffeineAlso: Coffeinum® NCaffeine | Drug | All participants |
| MidazolamAlso: Midazolam Accord®Midazolam | Drug | All participants |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Survodutide, Bupropion and Caffeine in people with Overweight and Obesity, run by Boehringer Ingelheim at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.