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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT06772532 (opens ClinicalTrials.gov in a new tab)Other id1404-0074Other id2024-516529-30-00Other idU1111-1310-7283

Overview

Status
Completed
Phase
Phase 1
Enrollment
30 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
10 Feb 2025
Primary completion
29 May 2025
Completion
10 Jun 2025
First posted
13 Jan 2025
Last update posted
13 Mar 2026
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026
  1. Ph 1

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

    NCT06772532

    10 Feb 2025 to 10 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • BI 456906 - Formulation ACombination product
  • BI 456906 - Formulation BDrug
  • BI 456906 - Formulation CDrug

Arms3

  • Experimental

    Treatment sequence R-T2-T1

    T1: BI 456906 formulation B T2: BI 456906 formulation C R: BI 456906 formulation A

  • Experimental

    Treatment sequence T1-R-T2

  • Experimental

    Treatment sequence T2-T1-R

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · Up to 22 days

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

    Time frame · Up to 22 days

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

    Time frame · Up to 22 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. * 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 Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Further inclusion criteria apply. Exclusion Criteria: * Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator. * Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(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 to be of clinical relevance. * Any evidence of a concomitant disease assessed as clinically relevant by the investigator. Further exclusion criteria apply.

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