DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02060266

CompletedPhase 1

Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male Subjects

A Single Centre, Open Label Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

7

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-30•Male•Healthy volunteers

Primary endpoint

•Plasma concentration (steady state)

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 IDNCT02060266
Org study IDNN9535-3789
Secondary ID2013-001769-18
Secondary IDU1111-1142-0810WHO

Timeline

Milestones

Study start2014-02-04actual
Study first posted2014-02-12estimated
Primary completion2014-04-28actual
Study completion2014-04-28actual
Last update posted2017-03-28actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age45 Years
Maximum age64 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Healthy male subjects, based on an assessment of medical history, physical examination, ECG (electrocardiogram) and vital signs, as determined by the investigator
•Age between 45-64 years (both inclusive) at the time of signing inform consent
•Body mass index (BMI) between 20 and 30 kg/m^2 (both inclusive)

Exclusion criteria

•Donation of any blood or plasma in the past month or in excess of 100 mL within the 3 months preceding screening, or surgery or trauma with more than 100 mL blood loss within the 3 months preceding screening
•Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to visit 2, Day 1
•History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
•History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
•Smoking or use of any nicotine (including nicotine patches, gum, etc) in the last 3 months prior to screening or a positive nicotine test

Endpoints (6)

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

6 endpoints
Primary/protocol endpoint

Concentration of the major metabolites of [3H]-semaglutide in plasma, urine, and faeces

Time frame:Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Total amount of [3H]-semaglutide related material excreted in urine (% of dose)

Time frame:Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide

percent change from baseline, descriptive

Secondary/protocol endpoint

Total amount of [3H]-semaglutide related material excreted in faeces (% of dose)

Time frame:Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide

percent change from baseline, descriptive

Secondary/protocol endpoint

Blood to plasma ratio of [3H]-semaglutide related material

Time frame:Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide

ratio, descriptive

Secondary/protocol endpoint

Area under the semaglutide plasma concentration curve

Time frame:From time 0 until infinity after a single dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed semaglutide plasma concentration

Time frame:After a single dose

Cmax

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.