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CompletedPhase 1

Comparison of the Effect of Liraglutide in Young Versus Elderly Healthy Volunteers

An Open Label, Single Dose Trial With Two Groups Comparing the Pharmacokinetics of Liraglutide in Young Versus Elderly Healthy Subjects of Both Sexes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

32

actual

Study population

Healthy volunteers

Key I/E criterion

BMI 18-30

Primary endpoint

AUC of liraglutide (AUC 0-t)

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 IDNCT01507337
Org study IDNN2211-1327

Timeline

Milestones

Study first posted2012-01-10estimated
Last update posted2017-01-24estimated
Study start2004-04 (month precision)
Primary completion2004-06actual (month precision)
Study completion2004-06actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

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
Age, young subjects: age 18-45 years (both incl.)
Age, elderly subjects: age at least 65 years
Body Mass Index (BMI) 18-30 kg/m^2 (both incl.)
Blood pressure, young: Diastolic 50-90 mmHg, systolic 90-140 mmHg
Blood pressure, elderly: Diastolic 50-95 mmHg, systolic 92-160 mmHg

Exclusion criteria

History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease, or other major disorders that could interfere with the objectives of the trial, as judged by the investigator
Impaired renal function
Any clinically significant abnormal ECG (electrocardiogram)
Active hepatitis B and/or active hepatitis C
Positive HIV (human immunodeficiency virus) antibodies
Febrile illness within 5 days prior to first administration of liraglutide
History of alcoholism or drug abuse during the last 12 months
Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator

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

Area under the liraglutide plasma concentration time curve (AUC 0-t)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Area under the liraglutide plasma concentration time curve (AUC 0-infinity)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum liraglutide plasma concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to reach Cmax

Tmax

descriptive

Secondary/protocol endpoint

t½, terminal plasma elimination half-life

Half-life

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

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.

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.