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CompletedPhase 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

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

Enrollment

34

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

BMI 27-39.9Healthy volunteers

Primary endpoints

AUC of bupropion in plasma over the time interval from 0 extrapolatedAUC of the caffeine in plasma over the time interval from 0 extrapolatedAUC of midazolam in plasma over the time interval from 0 extrapolated

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06564441
Org study ID1404-0008
Secondary ID2024-512332-29-00CTIS (EU)
Secondary IDU1111-1307-0132WHO International Clinical Trials Registry Platform (ICTRP)

Timeline

Milestones

Study first posted2024-08-21actual
Study start2024-10-01actual
Primary completion2025-12-16actual
Study completion2026-01-05actual
Last update posted2026-03-13actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum measured concentration of bupropion in plasma (Cmax)

Time frame:Up to week 32

Cmax

concentration, descriptive

Primary/protocol endpoint

Maximum measured concentration of caffeine in plasma (Cmax)

Time frame:Up to week 32

Cmax

concentration, descriptive

Primary/protocol endpoint

Maximum measured concentration of midazolam in plasma (Cmax)

Time frame:Up to week 32

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.