Current partner codePEPTIDESDE
NCT07071974·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

16

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 reference formulation (Formulation A) vs. BI 456906 test formulation (Formulation B2).

Interventions

Treatment arms and agents.

COMBINATION_PRODUCT

BI 456906 formulation A

BI 456906 formulation A

DRUG

BI 456906 formulation B2

BI 456906 formulation B2

Timeline

From registration to results.

  1. First posted

    Jul 18, 2025

  2. Study start

    Jul 28, 2025

  3. Primary completion

    Oct 7, 2025

  4. Study completion

    Oct 28, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Mar 13, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Cmax (maximum measured concentration of the analyte in plasma)

Time frame · Up to 22 days.

Secondary outcomes

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
55 Years
Sex
ALL
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 exclusion criteria apply.

Study locations

1 registered sites.

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

CRS Clinical Research Services Berlin GmbH

Berlin, 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.