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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01620476

Enrollment

Registered

2012-06-15

Start date

2003-09-30

Completion date

2004-03-31

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, Healthy

Brief summary

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

Interventions

DRUGliraglutide

5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the plasma liraglutide curve	—

Secondary

Measure	Time frame
Adverse events	—
Terminal phase elimination rate-constant	—
t½, terminal elimination half life	—
24-hour profiles of plasma glucagon	—
24-hour profiles of serum glucose	—
Cmax, maximum plasma liraglutide concentration	—
tmax, time to reach Cmax	—
24-hour profiles of serum insulin	—

Countries

Japan

Outcome results

None listed

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