CompletedPhase 1

Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

A Randomised, Double-blind, Single-centre, Placebo-controlled, 21-day Multiple s.c. Doses, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) in Healthy Japanese Male 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•Male•Healthy volunteers

Primary endpoint

•Area under the plasma liraglutide curve

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 IDNCT01620476

Org study IDNN2211-1551

Timeline

Milestones

Study first posted2012-06-15estimated

Last update posted2017-01-25estimated

Study start2003-09 (month precision)

Primary completion2004-03actual (month precision)

Study completion2004-03actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age20 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Healthy

•Japanese

•Body mass index (BMI) between 18 and 27 kg/m^2 inclusive

Exclusion criteria

•Any clinical laboratory values deviated from the reference range at the laboratory

•Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders

•Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive

•History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders.

•History of significant allergy or hypersensitivity

•Known or suspected allergy to trial product or related products.

•History of drug or alcohol abuse

•Smokes more than 15 cigarettes, or the equivalent, per day andis unwilling to refrain from smoking whenever required for the trial procedure

Endpoints (9)

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.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

24-hour profiles of serum insulin

descriptive

Secondary/protocol endpoint

24-hour profiles of serum glucose

descriptive

Secondary/protocol endpoint

24-hour profiles of plasma glucagon

concentration, descriptive

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Area under the plasma liraglutide curve

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum plasma liraglutide concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to reach Cmax

Tmax

descriptive

Secondary/protocol endpoint

Terminal phase elimination rate-constant

descriptive

Secondary/protocol endpoint

t½, terminal elimination half life

Half-life

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive

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.