A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body

Last updated: May 12, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

BI 456906 - Formulation B

BI 456906 - Formulation A

BI 456906 - Formulation C

Clinical Study ID

NCT06772532
1404-0074
2024-516529-30-00
U1111-1310-7283
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main objective of this trial is to investigate relative bioavailability of BI 456906 formulation B and BI 456906 formulation C vs. BI 456906 formulation A.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male or female subjects according to the assessment of the investigator, asbased on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), andclinical laboratory tests.

  • Age of 18 to 55 years (inclusive).

  • Body mass index (BMI) of 20 to 29.9 kg/m² (inclusive)

  • Signed and dated written informed consent in accordance with International Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial.

Further inclusion criteria apply.

Exclusion

Exclusion Criteria:

  • Any finding in the medical examination (including BP, PR or ECG) deviating fromnormal and assessed as clinically relevant by the investigator.

  • Repeated measurement of systolic blood pressure outside the range of 90 to 140millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm).

  • Any laboratory value outside the reference range that the investigator considers tobe of clinical relevance.

  • Any evidence of a concomitant disease assessed as clinically relevant by theinvestigator.

Further exclusion criteria apply.

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: BI 456906 - Formulation B
Phase: 1
Study Start date:
February 10, 2025
Estimated Completion Date:
June 03, 2025

Connect with a study center

  • Humanpharmakologisches Zentrum Biberach

    Biberach, 88397
    Germany

    Site Not Available

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