DelfaGLP-1 Atlas

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CompletedPhase 1

Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

A Single-Centre, Open Label Trial Investigating the Metabolites in Plasma, Urine and Faeces After a Single Subcutaneous Dose of [3H]-Liraglutide to Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

7

estimated

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-27•Male

Primary endpoints

•Profile and identity of the major metabolites of tritium labelled liraglutide•Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces

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 IDNCT01517568
Org study IDNN2211-1699
Secondary ID2006-002293-22

Timeline

Milestones

Study first posted2012-01-25estimated
Last update posted2017-01-26estimated
Study start2006-11 (month precision)
Primary completion2006-12actual (month precision)
Study completion2006-12actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age30 Years
Maximum age65 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

•Good general health as judged by the Investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments
•BMI (Boday Mass Index) of 20.0-27.0 kg/m^2, both inclusive

Exclusion criteria

•History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
•Impaired renal function
•Active hepatitis B or active hepatitis C
•Positive human immunodeficiency virus (HIV) antibodies
•Any clinically significant abnormal ECG, as judged by the Investigator
•Any clinically significant abnormal laboratory test results, as judged by the Investigator
•Acute infection or inflammation or other illness that may influence the metabolism and excretion pattern of the trial product, as judged by the Investigator
•Known or suspected allergy to trial product(s) or related products
•History of alcoholism or drug abuse or positive results in alcohol and drug screens
•Smoking of more than 5 cigarettes per day
•Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator
•Excessive consumption of a diet deviating from a normal diet, as judged by the Investigator

Endpoints (8)

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

8 endpoints
Primary/protocol endpoint

Profile and identity of the major metabolites of tritium labelled liraglutide in plasma, urine, and faeces

descriptive

Primary/protocol endpoint

Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces

descriptive

Secondary/protocol endpoint

Area under the curve

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to reach Cmax

Tmax

descriptive

Secondary/protocol endpoint

t½, terminal half-life

Half-life

descriptive

Secondary/protocol endpoint

The distribution of [3H]-liraglutide in whole blood versus plasma

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, event

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.