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

Relative Bioavailability of Two BI 456906 Formulations After Subcutaneous Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07071974

Enrollment

Registered

2025-07-18

Start date

2025-07-28

Completion date

2025-10-28

Last updated

2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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).

Interventions

COMBINATION_PRODUCTBI 456906 formulation A

BI 456906 formulation A

DRUGBI 456906 formulation B2

BI 456906 formulation B2

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Trial participants will only be included in the trial if they meet the following criteria: 1. 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 2. Age of 18 to 55 years (inclusive) 3. Body Mass Index (BMI) of 18.5 to 29.9 kg/m (inclusive) 4. 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

: Participants will not be allowed to participate, if any of the following general criteria apply: 1. Any finding in the medical examination (BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. 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) 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 Upper limit of normal (ULN) + 20% * Gamma Glutamil Transferase (GGT) above Upper limit of normal (ULN) + 20% * Lipase or amylase above Upper limit of normal (ULN) + 20% * Bilirubin above 1.2x Upper limit of normal (ULN) (except for cases of Gilbert's Syndrome) * Estimated Glomerular Filtration Rate Estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73 m² 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further

Design outcomes

Primary

Measure	Time frame
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)	Up to 22 days.
Cmax (maximum measured concentration of the analyte in plasma)	Up to 22 days.

Secondary

Measure	Time frame
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	Up to 22 days.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026