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This study is a multicenter, randomized, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR18 | Experimental | GZR18 injection s.c. |
|
| Placebo | Placebo Comparator | Placebo injection s.c. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR18 | Drug | Titrated to dose 1, dose 2, dose 3 or dose 4 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent (%) change from baseline in body weight at the end of the study (W30) | 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline. | 30 weeks | |
| Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI) | Changes from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyuan Zhao, Ph.D | Gan & Lee Pharmaceuticals. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gan & Lee Pharmaceuticals Co., Ltd | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41760612 | Derived | Ji L, Gao L, Tian J, Dong R, Zhang Z, Shu H, Zhao J, Zhao L, He A, Xie T, Li Y, Chen W. Efficacy and safety of bofanglutide, a GLP-1 receptor agonist, in Chinese adults with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial. Signal Transduct Target Ther. 2026 Feb 27;11(1):73. doi: 10.1038/s41392-026-02586-8. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Other |
Administered the same volume as GZR18 |
|
| 30 weeks |
| Percentage (%) of weight | Change from baseline at the last safety follow-up visit (W33) after discontinuation | 33 weeks |
| 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) | Changes from baseline | 30 weeks |
| 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) | Changes from baseline | 30 weeks |
| Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale | Changes from baseline | 30 weeks |
| Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection | Changes from baseline | 33 weeks |
| AUClast, AUC0-inf, Tmax, λz, t1/2, tlag, CL/F, Vz/F, AUC%extra, MRT, Css_min, Css_max, Css_av, DF, Css_min | 30 weeks |
| The number of adverse events (AEs)/serious adverse events (SAEs) /AEs of special interest (AESIs) that occurred during the study. | 33 weeks |
| 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 | Change from baseline | 33 weeks |
| Subject's mental health status (assessed by using the Columbia-Suicide Severity Rating Scale and Patient Health Questionnaire (PHQ-9)) | 33 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |