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← All trials/NCT00761540

CompletedPhase 1

To Investigate the Blood Concentration of Liraglutide as Well as the Effects on Glucose and Insulin After 21 Days of Daily Subcutaneous Injections of Liraglutide or Placebo

A Dose Escalation Study to Investigate the Pharmacokinetics, Tolerability and Safety of Liraglutide After Multiple s.c. Doses in Healthy Chinese Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

37

Study population

Healthy volunteers

Eligibility highlights

•BMI 19-27•Male•Healthy volunteers

Primary endpoint

•AUC 0-24h (last dosing day)

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 IDNCT00761540
Org study IDNN2211-3533

Timeline

Milestones

Study first posted2008-09-29estimated
Last update posted2017-01-26estimated
Study start2008-10 (month precision)
Primary completion2008-12actual (month precision)
Study completion2008-12actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Informed consent obtained before any trial related activities
•Healthy Chinese male subjects
•Body mass index (BMI) between 19.0 and 27.0 kg/m2 (both inclusive)
•Fasting plasma glucose less than 6.0 mmol/L
•Non-smoker

Exclusion criteria

•Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
•Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
•Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90- 140 mmHg systolic and/or 40 - 90 mmHg diastolic
•Pulse in supine position at the screening, after resting for 5 min, outside the range 40 - 100 times/min
•Hepatitis B surface antigen, Hepatitis C antibodies or HIV antibodies positive.

Endpoints (4)

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

4 endpoints
Primary/protocol endpoint

AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing.

Time frame:After 21 days of treatment

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

AUC 0-24h: Area under the plasma liraglutide curve from 0 to 24 hours after first dosing, AUC0-24h (Day 1)

Time frame:After 1 day of treatment

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Adverse events

Time frame:After 21 days of treatment

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Hypoglycaemic events

Time frame:After 21 days of treatment

event count, event

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

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.