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

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

It will also evaluate the effects of treatment on metabolic parameters, cardiovascular risk factors, and quality of life.

It had two arms (groups): Group A: Bofanglutida (GZR18), (experimental) and Group B: Semaglutide (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 352 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female participants aged ≥18 years. Willingness and ability to maintain a stable diet and physical activity regimen throughout the study. Ability to understand the study requirements and provide written informed consent prior to any study-specific procedures.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-09 with completion listed for 2027-12.

It ran at 6 sites in Mexico (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change in Body Weight From Baseline to Week 36 (time frame: Baseline to Week 36).

It also tracked 14 secondary outcomes, for example Change in Body Mass Index (BMI) From Baseline at Week 36, Change in Hemoglobin A1c (HbA1c) From Baseline at Week 36, Change in Fasting Plasma Glucose From Baseline at Week 36, Change in Systolic Blood Pressure From Baseline at Week 36, Change in Diastolic Blood Pressure From Baseline at Week 36 and Change in Total Cholesterol From Baseline at Week 36.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 352 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.