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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
Lead sponsor
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 events•Changes 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
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
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 endpointsChanges in weight from baseline to the end of treatment
Time frame:35 weeks
descriptive
Changes in Body mass index (BMI) from baseline to the end of treatment
Time frame:35 weeks
descriptive
Changes in Percentage of reduction in weight (%) from baseline to the end of treatment
Time frame:35 weeks
change from baseline, improvement
Changes in Waist circumference from baseline to the end of treatment
Time frame:35 weeks
descriptive
Proportion of subjects with ≥5% reduction in body weight from baseline.
Time frame:35 weeks
change from baseline, improvement
Safety / tolerability / PK
1 endpointIncidence of adverse events and serious adverse events
Time frame:38 weeks
event count, event
Other (unclassified)
1 endpointtrough 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
- Cell reports. Medicine2026 Apr 21PMID41956096doi:10.1016/j.xcrm.2026.102743via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.