drugset / Trial / NCT07622810

BALANCE-OBS: Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity

NCT07622810

Phase 3 Not yet recruiting 352 enrolled Carnot Laboratories
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2026-09
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bofanglutide Protein / enzyme biologic 48 mg Subcutaneous
Comparator Semaglutide Peptide 1 mg Subcutaneous

Indications