CompletedPhase 1

Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

A Randomised, Double-blind Within Dose Group, Single Centre, Placebo-controlled, Dose Escalation, Multiple s.c. Dose Study to Assess the Safety and Tolerability of Liraglutide 20 ug/kg and 25 ug/kg 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

Primary endpoints

•Treatment-emergent AEs (any)•Body weight•Immunogenicity (ADA)

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 IDNCT01515592

Org study IDNN2211-1694

Timeline

Milestones

Study first posted2012-01-24estimated

Last update posted2017-01-25estimated

Study start2006-01 (month precision)

Primary completion2006-04actual (month precision)

Study completion2006-04actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age20 Years

Maximum age45 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•Healthy Japanese subjects

•BMI (Body Mass Index) between 18.0-27.0 kg/m^2 inclusive

Exclusion criteria

•Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG (electrocardiogram) findings at the screening

•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

•The subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure

Endpoints (10)

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

Weight & body composition

1 endpoint

Primary/protocol endpoint

Body weight

descriptive, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

24-hour profiles of plasma glucose

descriptive

Secondary/protocol endpoint

24-hour profiles of serum insulin

descriptive

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive

Primary/protocol endpoint

Antibody against liraglutide

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Area under the plasma liraglutide concentration curve

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to reach Cmax

Tmax

descriptive

Secondary/protocol endpoint

Terminal elimination rate constant

descriptive

Secondary/protocol endpoint

t½, terminal elimination half-life

Half-life

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.

Registry references + supporting bibliography

Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study.
International journal of clinical pharmacology and therapeutics2008 Jun (month)PMID18541123doi:10.5414/cpp46273via CT.gov reference

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.