DelfaGLP-1 Atlas

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CompletedPhase 1

A Phase I Study of GZR18 Injection in Obese/Overweight Subjects

A Randomized, Double-Blind, Placebo-Controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PK/PD) of a Single Dose of GZR18 Injection in Obese/Overweight Subjects

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

16

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥26

Primary endpoints

•TEAE•Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)

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 IDNCT06548945
Org study IDGL-GLP-CH1017

Timeline

Milestones

Study start2023-04-25actual
Primary completion2023-08-14actual
Study completion2023-08-14actual
Study first posted2024-08-12actual
Last update posted2024-08-14actual

Assets

Investigational agents

GZR18

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Subjects sign the informed consent form (ICF) voluntarily.
•Chinese adult subjects, both male and female.
•18 to 65 years old (including both ends) at screening.
•BMI≥26.0 kg/m2 at screening.
•Stable weight before screening (i.e. self-reported weight change less than 5 kg within 8 weeks before screening).
•Female subjects have negative serum Human Chorionic Gonadotropin (HCG) during screening and baseline periods.
•Subjects have good daily habits and can maintain good communication with investigators and comply with various requirements of clinical trials.

Exclusion criteria

•Lactating women.
•History of fainting with blood and needles.
•Known or suspected allergy to study related products; or drug/food allergy history; or allergy-related diseases history.
•Subjects who have participated in other clinical trials and given investigational drugs or medical device interventions within 90 days before screening.
•History of drug abuse within 1 year before screening, or positive results in drug abuse screening (urine).
•Smokers who smoke ≥ 5 cigarettes per day within the previous 3 months before screening or cannot refrain from smoking throughout the trial period.
•Any vaccine has been used within 28 days before administration, as well as any vaccine that may be used throughout the trial period.
•Other scenarios judged by the investigator to render the subjects unsuitable for participating in this study.

Endpoints (15)

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
11
Weight & body composition
2
Other (unclassified)
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Weight

Time frame:50 days

descriptive

Secondary/protocol endpoint

Body Mass Index (BMI)

Time frame:50 days

descriptive

Safety / tolerability / PK

11 endpoints
Primary/protocol endpoint

TEAE

Time frame:50 days

descriptive

Primary/protocol endpoint

Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)

Time frame:50 days

descriptive

Secondary/protocol endpoint

Cmax

Time frame:50 days

concentration, descriptive

Secondary/protocol endpoint

AUClast

Time frame:50 days

descriptive

Secondary/protocol endpoint

AUC0-inf

Time frame:50 days

descriptive

Secondary/protocol endpoint

Tmax

Time frame:50 days

concentration, descriptive

Secondary/protocol endpoint

t1/2

Time frame:50 days

concentration, descriptive

Secondary/protocol endpoint

CL/F

Time frame:50 days

descriptive

Secondary/protocol endpoint

Vz/F

Time frame:50 days

descriptive

Secondary/protocol endpoint

AUC%extra

Time frame:50 days

concentration, descriptive

Secondary/protocol endpoint

MRT

Time frame:50 days

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

λz

Time frame:50 days

descriptive

Secondary/protocol endpoint/low confidence

tlag

Time frame:50 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.