DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06256562

CompletedPhase 2

A Study of GZR18 Injection in Obese/Overweight Patients

A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

340

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoint

•Percent (%) change from baseline in body weight at the end of the study (W30)

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 IDNCT06256562
Org study IDGL-GLP-CH2005

Timeline

Milestones

Study start2023-06-08actual
Study first posted2024-02-13actual
Primary completion2024-06-05actual
Study completion2024-06-05actual
Last update posted2025-10-01actual

Assets

Investigational agents

GZR18

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

•Inclusion Criteria:

1. Male or female aged 18-75 years (inclusive).

2. Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI<28 kg/m2) with at least one comorbidity.

3. Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.

•Exclusion Criteria:

1. Limb deformities or defects affecting height and body weight measurement.

2. Pregnant or lactating women, men or women of reproductive potential unwilling to use contraception throughout the study and for 6 months after the last dose of investigational drug.

3. History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.

4. Alcohol abuse history within 6 months prior to screening.

5. Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.

6. Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.

Endpoints (12)

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
4
Glycemic / diabetes
1
Cardiometabolic biomarkers
1
Patient-reported / QoL
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Percent (%) change from baseline in body weight at the end of the study (W30)

Time frame:30 weeks

change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline.

Time frame:30 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI)

Time frame:30 weeks

ratio, improvement

Secondary/protocol endpoint

Percentage (%) of weight

Time frame:33 weeks

descriptive

Secondary/protocol endpoint

Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale

Time frame:30 weeks

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Glucose metabolism indicators: glycated hemoglobin A1C (HbA1c), fasting plasma glucose (FPG), fasting insulin, insulin resistance index (HOMA-IR), and islet β cell function (HOMA-β)

Time frame:30 weeks

concentration, descriptive

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Cardiovascular disease risk factors: blood pressure (SBP and DBP), pulse, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides (TG)

Time frame:30 weeks

descriptive

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Subject's mental health status (assessed by using the Columbia-Suicide Severity Rating Scale and Patient Health Questionnaire (PHQ-9))

Time frame:33 weeks

categorical status, descriptive

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection

Time frame:33 weeks

descriptive

Secondary/protocol endpoint

AUClast, AUC0-inf, Tmax, λz, t1/2, tlag, CL/F, Vz/F, AUC%extra, MRT, Css_min, Css_max, Css_av, DF, Css_min

Time frame:30 weeks

concentration, descriptive

Secondary/protocol endpoint

The number of adverse events (AEs)/serious adverse events (SAEs) /AEs of special interest (AESIs) that occurred during the study.

Time frame:33 weeks

event count, event

Secondary/protocol endpoint

Vital signs, physical examination, 12-lead Electrocardiogram (ECG), and clinical laboratory tests (hematology, urinalysis, blood biochemistry, blood amylase, blood lipase, coagulation function, calcitonin,TSH/FT3/FT4

Time frame:33 weeks

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.