← Trials/Trial dossier/NCT06974487

Not yet recruitingPhase 1

A Phase I Study to Evaluate the PK and PD Profiles of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects

A Randomized, Double-Blind, Crossover Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD Profiles of a Single Dose of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

30

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI 24-28

Primary endpoint

AUC0-t

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 IDNCT06974487
Org study IDGZR102-T2D-101

Timeline

Milestones

Study start2025-05-08estimated
Study first posted2025-05-16actual
Last update posted2025-05-16actual
Primary completion2025-09-30estimated
Study completion2025-09-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.

2. Subjects (male or female) age 18-60 years old (inclusive) at the time of signing ICF.

3. Body weight ≥ 60 kg, body mass index (BMI) ≥ 24 kg/m2 and < 28 kg/m2 at screening.

4. No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of blood pregnancy tests at screening and predose.

Exclusion criteria

1. History of drug abuse prior to screening; or positive results for drug abuse at screening.

2. History of alcohol abuse defined as an average alcohol intake of more than 14 units per week (1 standard unit = 360 mL of beer or 150 mL of 12% wine or 45 mL of 40% spirits) within 6 months prior to screening.

3. Subjects who smoked > 5 cigarettes/day within 3 months prior to screening or who cannot stop using any tobacco products during the study.

4. Subjects with a history of allergy to ≥ 2 drugs, or known hypersensitivity or intolerance to the IMP or similar products and their excipients.

5. Presence of any suspected and/or definitively diagnosed malignancy at screening; or patients diagnosed with other malignancies within 5 years; 6. Previous or current medical history of cardiovascular, hematological, respiratory, digestive, urinary, endocrine/metabolic, neurological, or psychiatric disorders that, in the investigator's judgment, may affect the study outcomes.

7. History of acute or chronic pancreatitis, biliary/gallbladder diseases , or pancreatic injury.

8. Major surgery (including but not limited to procedures requiring general anesthesia) within 3 months prior to screening; or history of organ transplantation (except corneal transplantation performed more than 4 months prior to screening); or incomplete recovery from illness, trauma, or surgery at screening (e.g., significant impairment in daily living or working capacity compared to pre-illness/injury/surgery status); or planned surgery during the study period.

9. Blood donation or significant blood loss (> 400 mL), or blood transfusion in the 3 months prior to screening.

10. Presence of any clinically significant abnormalities in 12-lead electrocardiogram, vital signs (blood pressure, respiration, pulse rate, body temperature), physical examination, imaging examination, or laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, serum amylase, serum lipase, calcitonin) as determined by the investigator at screening..

11. Positive screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody infection at screening.

12. History of organ transplantation, or acquired or congenital immune system disorders.

13. Participation in a clinical study of another investigational medicinal product (IMP), surgery, or device within 3 months before screening, or within 5 half-lives of the previous IMP (whichever is longer). Or plan to participate in another clinical study of an IMP, surgery, or device before completing all scheduled assessments in the clinical study.

14. Subjects who have used GLP-1 receptor agonists or drugs with the mechanism of action of GLP-1R agonists.

15. Subjects who are allergic to any food or have specific dietary requirements and cannot adhere to a standardized diet.

16. History of needle or blood phobia, or difficulty with blood collection; or inability/unwillingness to undergo repeated venipuncture.

17. Subjects who were considered not suitable for the clinical study due to other reasons at the discretion of the investigator.

Endpoints (6)

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

6 endpoints
Primary/protocol endpoint

AUC0-t

Time frame:Day 36 (end of period)

descriptive

Secondary/protocol endpoint

AUC0-inf

Time frame:Day 36 (end of period)

descriptive

Secondary/protocol endpoint

TEAEs

Time frame:Day 36 (end of period)

descriptive

Secondary/protocol endpoint

Hypoglycemia

Time frame:Day 36 (end of period)

descriptive

Secondary/protocol endpoint

Immunogenicity

Time frame:Day 36 (end of period)

descriptive

Secondary/protocol endpoint

Cmax

Time frame:Day 36 (end of period)

concentration, 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.