CompletedPhase 1

Comparison of Two Liraglutide Formulations in Healthy Volunteers

A Randomized, Single-blind, Single-centre, Two-period, Cross-over Trial Investigating the Bioequivalence Between Completed Phase 2 and Planned Phase 3 Formulations of Liraglutide in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 18-27

Primary endpoints

•Area under the Curve (AUC) (0-t)•Cmax, Cmax

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 IDNCT01508897

Org study IDNN2211-1331

Timeline

Milestones

Study start2004-05-28actual

Primary completion2004-06-30actual

Study completion2004-06-30actual

Study first posted2012-01-12estimated

Last update posted2024-01-02actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age50 Years

SexAll

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

•Body Mass Index (BMI) of 18-27 kg/m^2 incl.

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 study, as judged by the investigator

•Impaired renal function

•Uncontrolled treated/untreated hypertension

•Any clinically significant abnormal ECG

•Active hepatitis B and/or active hepatitis C

•Positive HIV (human immunodeficiency virus) antibodies

•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

•Excessive consumption of a diet deviating from a normal diet as judged by the Investigator

Endpoints (7)

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

7 endpoints

Primary/protocol endpoint

Area under the Curve (AUC) (0-t)

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC (0-infinity)

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

tmax, time to maximum concentration

Tmax

descriptive

Secondary/protocol endpoint

t½, terminal half-life

Half-life

descriptive

Secondary/protocol endpoint

Terminal elimination rate constant

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, event

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.