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CompletedPhase 1

A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects

A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

32

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 19-26MaleHealthy volunteers

Primary endpoints

Peak Plasma Concentration (Cmax)AUC0-tAUC0-∞

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 IDNCT05225974
Org study IDNBT-1698-P1

Timeline

Milestones

Study start2021-07-16actual
Primary completion2021-07-30actual
Study completion2021-08-19actual
Study first posted2022-02-07actual
Last update posted2022-02-07actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

Healthy male vulunteers aged 18 and above.
The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value).
Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion criteria

Medical examinations revealed clinically significant abnormalities or any evidence or history of clinically significant disease.
Volunteers who had used systemic glucocorticoid drugs within 3 months before enrollment.
Participation in another clinical trial within 3 months.
Smoking more than 5 cigarettes per day during the 3 months prior to screening.
Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
Any use of other prescription drugs (including contraceptive)#over-thecounter drugs, Chinese herbal medicine, health care products and 30 days prior to medication for this study.

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

Peak Plasma Concentration (Cmax)

Time frame:40 days

Cmax

concentration, descriptive

Primary/protocol endpoint

Area under the plasma concentration versus time curve (AUC)0-t

Time frame:40 days

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the plasma concentration versus time curve (AUC)0-∞

Time frame:40 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events

Time frame:40 days

Treatment-emergent AEs (any)

event count, event

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.