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Completed

NCT Number: NCT07071974

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

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).

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Trial participants will only be included in the trial if they meet the following 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

Participants will not be allowed to participate, if any of the following general criteria apply:

  • 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:
  • 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
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Treatment and study plan

BI 456906 formulation A

Combination Product

BI 456906 formulation A

Other names: Survodutide

BI 456906 formulation B2

Drug

BI 456906 formulation B2

Other names: Survodutide

Primary outcomes

  1. 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)

    Time frame: Up to 22 days.

  2. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: Up to 22 days.

Secondary outcomes

  1. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: Up to 22 days.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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