> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-gzr18-injection-in-obese-overweight-patients-5fd2c091-2cc2-43f2-8a1d-acf642b19855 > Record changed: 2026-10-13 # A Study of GZR18 Injection in Obese/Overweight Patients NCT06256562 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) Participants 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) Lead sponsor Gan and Lee Pharmaceuticals, USA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) Start date 2023-06-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Short title** A Study of GZR18 Injection in Obese/Overweight Patients Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Official title** A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Dates **Completion date** 2024-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **First posted** 2024-02-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Registry last updated** 2025-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Primary completion date** 2024-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Start date** 2023-06-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Size and sites **Actual participants** 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Participants** 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Lead sponsor** Gan and Lee Pharmaceuticals, USA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Identifiers **Registry ID** NCT06256562 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **ClinicalTrials.gov ID** NCT06256562 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Outcomes ### Primary outcomes 1. Percent (%) change from baseline in body weight at the end of the study (W30) Timeframe: 30 weeks ### Secondary outcomes 1. Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline. Timeframe: 30 weeks 2. Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI) Timeframe: 30 weeks Changes from baseline 3. Percentage (%) of weight Timeframe: 33 weeks Change from baseline at the last safety follow-up visit (W33) after discontinuation 4. 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) Timeframe: 30 weeks Changes from baseline 5. 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) Timeframe: 30 weeks Changes from baseline 6. Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale Timeframe: 30 weeks Changes from baseline 7. Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection Timeframe: 33 weeks Changes from baseline 8. AUClast, AUC0-inf, Tmax, λz, t1/2, tlag, CL/F, Vz/F, AUC%extra, MRT, Css\_min, Css\_max, Css\_av, DF, Css\_min Timeframe: 30 weeks 9. The number of adverse events (AEs)/serious adverse events (SAEs) /AEs of special interest (AESIs) that occurred during the study. Timeframe: 33 weeks 10. 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 Timeframe: 33 weeks Change from baseline 11. Subject's mental health status (assessed by using the Columbia-Suicide Severity Rating Scale and Patient Health Questionnaire (PHQ-9)) Timeframe: 33 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Sites - Gan & Lee Pharmaceuticals Co., LtdBeijing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## References - PubMed 41760612 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41760612/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06256562) ## Related records ### Drugs (1) - [Bofanglutide](https://trialight.com/data/asset/bofanglutide-35c869ee-ff48-4421-a0b9-f1eac8a5a180.md) ### Lead sponsors (1) - [Gan and Lee Pharmaceuticals, USA](https://trialight.com/data/company/gan-and-lee-pharmaceuticals-usa-29a75715-56e9-4149-af78-94050b0bf55b.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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