CompletedPhase 1

A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body

Germany16 participantsStarted 2025-07-28

Plain-language summary

The main objective of this trial is to investigate relative bioavailability of BI 456906 reference formulation (Formulation A) vs. BI 456906 test formulation (Formulation B2).

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Healthy male or female trial participant 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 55 years (inclusive)
✓. Body Mass Index (BMI) of 18.5 to 29.9 kg/m (inclusive)
✓. Signed and dated written informed consent in accordance with ICH-GCP (Harmonized Guideline for Good Clinical Practice) and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion criteria

✕. Any finding in the medical examination (BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
✕. Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 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.

What they're measuring

AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

Timeframe: Up to 22 days.

Cmax (maximum measured concentration of the analyte in plasma)

Timeframe: Up to 22 days.

Trial details

NCT IDNCT07071974

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-07

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