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NOT YET RECRUITING
NCT07622810
PHASE3

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

Sponsor: Carnot Laboratories

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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