DelfaGLP-1 Atlas

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CompletedPhase 1

A Study in Healthy Men to Test How BI 456906 is Processed in the Body

A Phase I, Open-label, Single-dose, Single-arm Trial to Investigate Metabolism and Pharmacokinetics of BI 456906 (C-14) Administered Subcutaneously to (Otherwise) Healthy Male Volunteers With Normal Body Weight, Overweight or Obesity

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

—

Enrollment

6

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•Male•Healthy volunteers

Primary endpoints

•Fraction of [14C]-radioactivity excreted in urine expressed as percentage•Fraction of [14C]-radioactivity excreted in faeces expressed as percentage

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 IDNCT05421338
Org study ID1404-0012
Secondary ID2021-006690-28

Timeline

Milestones

Study first posted2022-06-16actual
Study start2022-07-04actual
Primary completion2022-11-17actual
Study completion2022-11-17actual
Last update posted2022-12-14actual

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Healthy male subjects with normal Body mass index (BMI) or otherwise healthy male subjects with overweight/obesity 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)
•BMI of 23.0 to 34.9 kg/m2 (inclusive); body weight of at least 70 kg.
•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

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 mmHg, diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 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
•Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
•Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
•Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
•History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Endpoints (4)

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

4 endpoints
Primary/protocol endpoint

Fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe_urine, 0-tz)

Time frame:up to 7 weeks

percent change from baseline, descriptive

Primary/protocol endpoint

Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe_faeces, 0-tz)

Time frame:up to 7 weeks

percent change from baseline, descriptive

Secondary/protocol endpoint

Maximum measured concentration of the analyte (Cmax)

Time frame:up to 22 days

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

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.