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BALANCE-OBS: Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity
Sponsor: Carnot Laboratories
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
Official title: BALANCE-OBS: A Multiregional, Randomized, Multicenter, Active-Controlled Confirmatory Phase III Study to Evaluate the Efficacy and Safety of Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
352
Start Date
2026-09
Completion Date
2027-12
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
Bofanglutida
Bofanglutide (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
Semaglutide 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.
Locations (6)
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Guadalajara, Jalisco, Mexico
CICMEX Centro de Investigación Clínica de México S de RL de CV.
Morelia, Michoacán, Mexico
SMIQ, S. de R.L. de C.V.
Querétaro City, Querétaro, Mexico
Investigación Médica Sonora S.C.
Hermosillo, Sonora, Mexico
Centro de Estudios de lnvestigación Metabólicos y Cardiovasculares, S.C.
Ciudad Madero, Tamaulipas, Mexico
Instituto Nacional de Cardiología "Ignacio Chávez"
Mexico City, Mexico