DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07071974

CompletedPhase 1

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

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)

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

—

Enrollment

16

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18.5-29.9•Healthy volunteers

Primary endpoints

•AUC0-tz•Cmax

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07071974
Org study ID1404-0099
Secondary ID2025-521419-37-00CTIS (EU)
Secondary IDU1111-1319-7116WHO International Clinical Trials Registry Platform (ICTRP)

Timeline

Milestones

Study first posted2025-07-18actual
Study start2025-07-28actual
Primary completion2025-10-07actual
Study completion2025-10-28actual
Last update posted2026-03-13actual

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

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.

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax (maximum measured concentration of the analyte in plasma)

Time frame:Up to 22 days.

Cmax

concentration, descriptive

Secondary/protocol endpoint

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.

AUC₀–∞

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.