Current partner codePEPTIDESDE
NCT06772532·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

30

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

COMBINATION_PRODUCT

BI 456906 - Formulation A

Formulation A

DRUG

BI 456906 - Formulation B

Formulation B

DRUG

BI 456906 - Formulation C

Formulation C

Timeline

From registration to results.

  1. First posted

    Jan 13, 2025

  2. Study start

    Feb 10, 2025

  3. Primary completion

    May 29, 2025

  4. Study completion

    Jun 10, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Mar 13, 2026

Outcomes

What the study measures.

Primary outcomes

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

Maximum measured concentration of the analyte in plasma (Cmax)

Time frame · Up to 22 days

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
55 Years
Sex
ALL
Healthy volunteers
Yes

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.

Study locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Humanpharmakologisches Zentrum Biberach

Biberach/Riß, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Survodutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.