DelfaGLP-1 Atlas

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CompletedPhase 1

A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects

A Randomized, Open-label, Two-period, and Double-cross Comparative Study on the Pharmacokinetics of Liraglutide Injection (RD12014) and Victoza® in Healthy Volunteers

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

50

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 19-26•Male•Healthy volunteers

Primary endpoints

•Maximum (peak) plasma drug concentration(Cmax)•AUC

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 IDNCT05294536
Org study ID12014-P-01/CRC-C1944

Timeline

Milestones

Study start2020-06-22actual
Primary completion2020-07-20actual
Study completion2020-11-27actual
Study first posted2022-03-24actual
Last update posted2022-03-24actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•1. Being willing to participate in the experiment, fully understand and sign the informed consent, fully understand and able to complete the experiment according to the requirements of the experiment protocol;
•2. Aged between 18 and 45 years old of healthy male subjects ;
•3. Weight ≥50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ;
•4. No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities;
•5. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, abdominal ultrasound examination and chest X-ray examination have no clinical significance;

Exclusion criteria

•1. Have a history of fainting needles, fainting blood;
•2. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
•3. Have taken any prescription, over-the-counter, herbal medicine or health care products (other than normal vitamin products)within 2 weeks prior to the use of the study drug;
•4. Have a history of taken Liraglutide or other human glucagon-like peptides-1 analogues before the trial;
•5. Those who have been screened positive for drugs at screening;
•6. Donated blood (> 400 ml) within 3 months before taking the study drug;
•7. Heavy smoker or those who smoked more than 10 cigarettes per day before taking the study drug.
•8. Alcohol abuse (drinking 21 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine) or positive for breath alcohol test ;
•9. Those who have been screened positive for drugs or have a history of drug abuse;
•10. Known allergy to Liraglutide or any of the excipients of the formulation;
•11. Those who have a history or family history of medullary thyroid cancer (grandparents, parents and siblings), or inherited diseases that predispose them to medullary thyroid cancer;Or have a history or family history of multiple endocrine adenomatosis;
•12. Have participated in the drug clinical trial and taken the test drug within 3 months before taking the study drug;
•13. During the trial period and within 3 months after the last dose, those who want their female partners to become pregnant or is unwilling to use reliable contraceptive methods
•14. Other cases judged by researchers to be unsuitable for selection.

Endpoints (8)

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

8 endpoints
Primary/protocol endpoint

Maximum (peak) plasma drug concentration(Cmax)

Time frame:0 hour（pre-dose,within 30mins） to 72 hours after administration

Cmax

concentration, descriptive

Primary/protocol endpoint

Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

Time frame:0 hour（pre-dose,within 30mins） to 72 hours after administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)

Time frame:0 hour（pre-dose,within 30mins） to infinity after administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to reach maximum plasma concentration following drug administration (Tmax)

Time frame:0 hour（pre-dose,within 30mins） to 72 hours after administration

Tmax

concentration, descriptive

Secondary/protocol endpoint

Elimination half-life (t1/2)

Time frame:0 hour（pre-dose,within 30mins） to 72 hours after administration

Half-life

descriptive

Secondary/protocol endpoint

Apparent total body clearance (CL/F)

Time frame:0 hour（pre-dose,within 30mins） to 72 hours after administration

descriptive

Secondary/protocol endpoint

Apparent volume of distribution (Vd/F)

Time frame:0 hour（pre-dose,within 30mins） to 72 hours after administration

descriptive

Secondary/protocol endpoint

Adverse Event, Serious Adverse Event

Time frame:Up to day 4 after the second dose.

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

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 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.