DelfaGLP-1 Atlas

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Active not recruitingPhase 1

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

Relative Bioavailability of Two Survodutide (BI 456906) Formulations When Administered Subcutaneously Via Pre-filled Syringe Over 28 Weeks (an Open-label, Randomised, Multiple Dose, Parallel Group Trial)

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

2

Recruiting sites

—

Enrollment

100

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 27-39.9•Healthy volunteers

Primary endpoints

•AUC of the analyte in plasma at steady state over a uniform dosing interval τ•Maximum measured concentration of the analyte in plasma at steady state over

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 IDNCT07221591
Org study ID1404-0103
Secondary ID2025-522325-35-00
Secondary IDU1111-1322-4700WHO - International Clinical Trials Registry Platform (ICTRP)

Timeline

Milestones

Study first posted2025-10-28actual
Study start2025-11-05actual
Last update posted2026-03-13actual
Primary completion2026-08-04estimated
Study completion2026-08-04estimated

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•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
•Age of 18 to 65 years (inclusive)
•Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive)
•Signed and dated written informed consent in accordance with 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 150 mmHg, diastolic blood pressure outside the range of 50 to 100 mmHg, or pulse rate outside the range of 50 to 100 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. Presence of hypertension, hypothyroidism, hyperuricaemia and hypercholesterolaemia are acceptable if well-controlled according to the investigator's judgement.

Further exclusion criteria apply.

Endpoints (2)

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

2 endpoints
Primary/protocol endpoint

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

Time frame:up to 232 days

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)

Time frame:up to 232 days

Cmax

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.