← Trials/Trial dossier/NCT06256536

CompletedPhase 1, PHASE2

A Study of GZR18 Injection in Chinese Obese/Overweight Patients

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Obese/Overweight Patients

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

60

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥28

Primary endpoints

Adverse events and serious adverse eventsChanges in weight from baseline to the end of treatment

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 IDNCT06256536
Org study IDGL-GLP-CH2002

Timeline

Milestones

Study start2022-07-14actual
Primary completion2023-10-22actual
Study completion2023-10-22actual
Study first posted2024-02-13actual
Last update posted2024-02-23actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female aged 18-65 years (inclusive);

2. Obese subjects: BMI ≥ 28.0 kg/m2; or overweight subjects: 24.0 ≤ BMI < 28.0 kg/m2 with at least one comorbidity;

3. Able to understand the procedures and methods in this study; willing to complete the study in strict accordance with the clinical study protocol and sign the ICF voluntarily.

Exclusion criteria

1. Suspicion that the subject may be allergic to any study drug or ingredient or congener from the investigator.

2. Subjects with body weight change > 5.0% for any reason (diet, exercise, etc.) within 12 weeks prior to screening.

3. Heart rate < 50 beats/min or > 100 beats/min on 12-lead ECG at screening.

4. Presence of the following clinically significant 12-lead ECG abnormalities at screening.

5. Alcohol abuse within 6 months prior to screening, or reluctance to stop alcohol abuse throughout the study, or a positive breath alcohol test result at screening.

Endpoints (7)

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

Weight & body composition
5
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Changes in weight from baseline to the end of treatment

Time frame:35 weeks

descriptive

Secondary/protocol endpoint

Changes in Body mass index (BMI) from baseline to the end of treatment

Time frame:35 weeks

descriptive

Secondary/protocol endpoint

Changes in Percentage of reduction in weight (%) from baseline to the end of treatment

Time frame:35 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in Waist circumference from baseline to the end of treatment

Time frame:35 weeks

descriptive

Secondary/protocol endpoint

Proportion of subjects with ≥5% reduction in body weight from baseline.

Time frame:35 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Incidence of adverse events and serious adverse events

Time frame:38 weeks

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

trough concentrations following consecutive doses

Time frame:35 weeks

concentration, descriptive

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.