DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01620463

CompletedPhase 1

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers

A Randomised, Double-blind, Single-centre, Placebo-controlled, Ascending Single s.c. Dose, Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 90-1170 in Healthy Japanese Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

32

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-27•Male

Primary endpoints

•Body weight•Vital signs (Blood pressure)•Heart rate, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01620463
Org study IDNN2211-1326

Timeline

Milestones

Study first posted2012-06-15estimated
Last update posted2017-01-24estimated
Study start2002-12 (month precision)
Primary completion2003-03actual (month precision)
Study completion2003-03actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age20 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Body Mass Index (BMI) between 18 and 27 kg/m^2, inclusive

Exclusion criteria

•Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator or Sub-Investigator
•Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the Investigator
•Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmHg systolic or 40-90 mmHg diastolic
•Heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min
•Alcohol intake within 48 hours prior to the screening
•Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
•Clinically relevant abnormal history or physical findings at the screening, which could interfere with the objectives of the study or the safety of the subject's participation, as judged by the Investigator
•History of significant allergy or hypersensitivity
•Known or suspected allergy to trial product or related products
•History of drug or alcohol abuse
•Smoking 10 cigarettes or more, or the equivalent, per day and is unwilling to refrain from smoking during 3 days prior to dosing and during the confinement period

Endpoints (12)

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
6
Glycemic / diabetes
2
Cardiometabolic biomarkers
2
Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Body weight

descriptive, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

24-hour glucose profile in serum

descriptive

Secondary/protocol endpoint/low confidence

24-hour insulin profile in serum

descriptive

Cardiometabolic biomarkers

2 endpoints
Primary/protocol endpoint

Vital signs (Blood pressure)

change from baseline, improvement

Primary/protocol endpoint

Vital signs (Pulse rate)

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

ECG (ElectroCardioGram)

descriptive

Primary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Area under the plasma NNC 90-1170 curve

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum plasma NNC 90-1170 concentration, Cmax

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to maximum plasma NNC 90-1170 concentration, tmax

Tmax

concentration, descriptive

Secondary/protocol endpoint

Terminal elimination half-life, t1/2

Half-life

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

24-hour glucagon profile in plasma

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.