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Delfa

← All trials/NCT01507272

CompletedPhase 1

Safety and Tolerability of Liraglutide in Healthy Male Volunteers

A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

34

Study population

Healthy volunteers

Eligibility highlights

•BMI 20-27•Male

Primary endpoint

•AUC

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01507272
Org study IDNN2211-1149

Timeline

Milestones

Study first posted2012-01-10estimated
Last update posted2017-01-24estimated
Study start1999-03 (month precision)
Primary completion1999-12actual (month precision)
Study completion1999-12actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

•Male subjects of any ethnic origin
•Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
•Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
•Body mass index within the range 20-27 kg/m^2, inclusive

Exclusion criteria

•Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG
•History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
•Alcohol intake within 48 hours of visit
•Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
•History of significant drug allergy or drug hypersensitivity
•Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period
•Subjects who drink more than 8 cups of tea/coffee per day

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

AUC (area under the curve)

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to maximum concentration

Tmax

descriptive

Secondary/protocol endpoint

t½, terminal half-life

Half-life

descriptive

Publications (2)

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 6, 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 6, 2026 snapshot.