A Study of GZR18 Injection in Obese/Overweight Patients
- Registration Number
- NCT06256562
- Lead Sponsor
- Gan and Lee Pharmaceuticals, USA
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 340
Inclusion Criteria
- Male or female aged 18-75 years (inclusive).
- Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI<28 kg/m2) with at least one comorbidity.
- 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
- Limb deformities or defects affecting height and body weight measurement.
- 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.
- History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.
- Alcohol abuse history within 6 months prior to screening.
- Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.
- Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo injection s.c. GZR18 GZR18 GZR18 injection s.c.
- Primary Outcome Measures
Name Time Method Percent (%) change from baseline in body weight at the end of the study (W30) 30 weeks
- Secondary Outcome Measures
Name Time Method 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) 30 weeks Changes from baseline
Percentage (%) of weight 33 weeks Change from baseline at the last safety follow-up visit (W33) after discontinuation
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) 30 weeks Changes from baseline
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) 30 weeks Changes from baseline
Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale 30 weeks Changes from baseline
Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection 33 weeks Changes from baseline
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 33 weeks Change from baseline
Subject's mental health status (assessed by using the Columbia-Suicide Severity Rating Scale and Patient Health Questionnaire (PHQ-9)) 33 weeks
Trial Locations
- Locations (1)
Gan & Lee Pharmaceuticals Co., Ltd
🇨🇳Beijing, China
Gan & Lee Pharmaceuticals Co., Ltd🇨🇳Beijing, China