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The study was 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 adult obese/overweight patients. This study is divided into Part A and Part B, which are to be conducted simultaneously.
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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 | 0.6 mg-30 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and serious adverse events | 38 weeks | |
| Changes in weight from baseline to the end of treatment | 35 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| trough concentrations following consecutive doses | 35 weeks | |
| Changes in Body mass index (BMI) from baseline to the end of treatment | 35 weeks | |
| Changes in Percentage of reduction in weight (%) from baseline to the end of treatment |
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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.
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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 |
|---|---|---|---|
| 41956096 | Derived | Ji L, Gao L, Dong R, Yuan M, Zhao D, Pang S, Zhao J, Zhao L, Chen W. GZR18, a GLP-1 analog with once-weekly or bi-weekly dosing for body weight management: A randomized, placebo-controlled, phase 1b/2a trial. Cell Rep Med. 2026 Apr 21;7(4):102743. doi: 10.1016/j.xcrm.2026.102743. Epub 2026 Apr 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 |
|
| 35 weeks |
| Changes in Waist circumference from baseline to the end of treatment | 35 weeks |
| Proportion of subjects with ≥5% reduction in body weight from baseline. | 35 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |