CompletedPhase 1

Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers

A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 3a Formulation of Liraglutide (Formulation 4) and the Planned Phase 3b Formulation (Final Formulation 4)

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 (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 IDNCT01515553

Org study IDNN2211-1692

Secondary ID2006-004283-31

Timeline

Milestones

Study first posted2012-01-24estimated

Last update posted2015-01-13estimated

Study start2007-01 (month precision)

Primary completion2007-04actual (month precision)

Study completion2007-04actual (month precision)

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

•BMI (Body Mass Index) of 18.0-27.0 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

•Any clinically significant abnormal ECG, as judged by the Investigator

•Active hepatitis B and/or active hepatitis C

•Positive human immunodeficiency virus (HIV) antibodies

•Known or suspected allergy to trial product(s) or related products

•Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures

•History of alcoholism or drug abuse, or positive results in alcohol or drug screens

•Smoking of more than 5 cigarettes per day, or the equivalent for other tobacco products

•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

Area under the curve (0-t)

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the curve (0-infinity)

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Relative bioavailability

descriptive

Secondary/protocol endpoint

Time to reach maximum (tmax)

Tmax

descriptive

Secondary/protocol endpoint

Terminal elimination half life (t½)

Half-life

descriptive

Secondary/protocol endpoint

Terminal elimination rate constant

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

event count, 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.