The goal of this clinical trial is to evaluate the efficacy and safety of Bofanglutide (GZR18) compared with Semaglutide in Latin American adults with overweight or obesity. It will also evaluate the effects of treatment on metabolic parameters, cardiovascular risk factors, and quality of life.
The main questions it aims to answer are:
Does Bofanglutide (GZR18) reduce body weight after 36 weeks of treatment compared with Semaglutide? What effects does Bofanglutide (GZR18) have on metabolic parameters, cardiovascular risk factors, and quality of life? How safe and well tolerated is treatment with Bofanglutide (GZR18)?
Researchers will compare Bofanglutide (GZR18) with Semaglutide, an active comparator, to evaluate efficacy and safety in adults with overweight or obesity.
Participants will:
Receive Bofanglutide (GZR18) every 2 weeks or Semaglutide once weekly by subcutaneous injection Follow standardized recommendations for diet and physical activity throughout the study Attend scheduled clinic visits for efficacy and safety assessments Participate in treatment and follow-up for up to 40 weeks, including screening, treatment, and safety follow-up periods
Male or female participants aged ≥18 years.
Body mass index (BMI): ≥30.0 kg/m² (obesity), or ≥27.0 kg/m² and <30.0 kg/m² (overweight) with at least one weight-related comorbidity, including impaired glucose metabolism, hypertension, dyslipidemia, metabolic dysfunction-associated steatotic liver disease (MASLD), osteoarthritis attributable to excess weight, or obstructive sleep apnea.
Body weight managed through diet and exercise alone for at least 12 weeks prior to screening, with <5% change in body weight during the previous 12 weeks.
Willingness and ability to maintain a stable diet and physical activity regimen throughout the study.
Known or suspected hypersensitivity to GLP-1 receptor agonists, GLP-1/GIP receptor agonists, or any component of the investigational product.
History of substance abuse or alcoholism within 6 months prior to screening.
Presence of conditions that may interfere with accurate anthropometric assessments.
History of bariatric surgery or planned bariatric surgery during the study.
Parallel
Bofanglutida
DrugBofanglutide (GZR18) is a long-acting GLP-1 receptor agonist administered by subcutaneous injection every 2 weeks. Participants will receive progressive dose titration starting at 3 mg up to a target dose of 48 mg according to the study protocol during the 36-week treatment period.
Semaglutide
DrugSemaglutide is a GLP-1 receptor agonist administered by weekly subcutaneous injection with progressive dose titration from 0.25 mg to 1 mg according to the study protocol during the 36-week treatment period.
Percent Change in Body Weight From Baseline to Week 36
Evaluation of the percent change in body weight from baseline to Week 36 in participants receiving Bofanglutide (GZR18) compared with Semaglutide.
Proportion of Participants Achieving Clinically Relevant Weight Reduction
Evaluation of the proportion of participants achieving clinically relevant body weight reductions of ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from baseline to Week 36.
Change in Body Mass Index (BMI) From Baseline at Week 36
Evaluation of the change in body mass index (BMI), expressed in kg/m², from baseline to Week 36 during treatment
Change in Hemoglobin A1c (HbA1c) From Baseline at Week 36
Evaluation of the change in glycated hemoglobin (HbA1c), expressed as percentage (%), from baseline to Week 36 during treatment
Change in Fasting Plasma Glucose From Baseline at Week 36
Evaluation of the change in fasting plasma glucose concentration from baseline to Week 36 during treatment
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