DelfaGLP-1 Atlas

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CompletedPhase 1

A Phase I Study of GZR18 Injection in Healthy Subjects

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GZR18 Injection in Healthy Subjects Following Single Dose and Once-weekly Dose for 2 Consecutive Weeks Until Reaching the Target Dose

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

57

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI ≤26

Primary endpoint

•TEAE

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 IDNCT06548997
Org study IDGL-GLP-CH1002

Timeline

Milestones

Study start2021-12-02actual
Primary completion2022-10-20actual
Study completion2022-10-20actual
Study first posted2024-08-12actual
Last update posted2024-08-14actual

Assets

Investigational agents

GZR18

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•1. Subjects sign informed consent voluntarily.
•2. Chinese adult subjects, male or female.
•3. Age 18-55 at screening (both included).
•4. At screening and baseline, 19.0 kg/m2 ≤ BMI ≤ 26.0 kg/m2 (male ≥55.0 kg, female ≥45.0 kg).
•5. Female subjects were human chorionic gonadotophin (HCG) negative at screening and baseline.

Exclusion criteria

•1. History of dizziness with blood and needles.
•2. Known or suspected allergy to study related products; or a history of drug and food allergies; or a history of allergy-related diseases.
•3. Participants who participated in other clinical trials and were given the investigational drug or medical device intervention within 90 days prior to screening.
•4. Blood donation, surgery, or trauma with significant blood loss (more than or equal to 400 mL, except for menstrual blood loss in women) within 12 weeks prior to screening.
•5. Any clinically significant medical history judged by the investigator, including but not limited to: lung, gastrointestinal, liver, nervous system, kidney, genitourinary and endocrine, skin, or blood disorders, especially a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 , and a history of pancreatitis (acute or chronic).
•6. At screening or baseline, physical examination showed clinically significant abnormalities judged by the investigator.

Endpoints (17)

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
13
Weight & body composition
2
Other (unclassified)
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

body weight

Time frame:28/35 days

descriptive

Secondary/protocol endpoint

body mass index (BMI）

Time frame:28/35 days

descriptive

Safety / tolerability / PK

13 endpoints
Primary/protocol endpoint

TEAE

Time frame:after 28/35 days of treatment

descriptive

Secondary/protocol endpoint

Cmax

Time frame:28/35 days

concentration, descriptive

Secondary/protocol endpoint

AUClast

Time frame:28/35 days

descriptive

Secondary/protocol endpoint

AUC0-inf

Time frame:28/35 days

descriptive

Secondary/protocol endpoint

Tmax

Time frame:28/35 days

concentration, descriptive

Secondary/protocol endpoint

t1/2

Time frame:28/35 days

concentration, descriptive

Secondary/protocol endpoint

CL/F

Time frame:28/35 days

descriptive

Secondary/protocol endpoint

Vz/F

Time frame:28/35 days

descriptive

Secondary/protocol endpoint

AUC%extra

Time frame:28/35 days

concentration, descriptive

Secondary/protocol endpoint

MRT

Time frame:28/35 days

descriptive

Secondary/protocol endpoint

AUCglucose0-14h

Time frame:28/35 days

descriptive

Secondary/protocol endpoint

AUCc-peptide0-14h

Time frame:28/35 days

descriptive

Secondary/protocol endpoint

AUCinsulin0-14h

Time frame:28/35 days

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

λz

Time frame:28/35 days

descriptive

Secondary/protocol endpoint/low confidence

tlag

Time frame:28/35 days

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.