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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01515592

Enrollment

Registered

2012-01-24

Start date

2006-01-31

Completion date

2006-04-30

Last updated

2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.

Interventions

DRUGliraglutide

One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg

DRUGplacebo

Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse events	—
Body weight	—
Antibody against liraglutide	—

Secondary

Measure	Time frame
Terminal elimination rate constant	—
t½, terminal elimination half-life	—
Area under the plasma liraglutide concentration curve	—
24-hour profiles of serum insulin	—
24-hour profiles of plasma glucose	—
Cmax, maximum concentration	—
tmax, time to reach Cmax	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026