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BALANCE-DM2 Study of Bofanglutide in Adults With Type 2 Diabetes

NCT07628985 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2026-06-05

No results posted yet for this study

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 type 2 diabetes mellitus who have inadequate glycemic control while receiving stable metformin monotherapy. The main questions it aims to answer are:

Does Bofanglutide (GZR18) provide glycemic control comparable to Semaglutide based on changes in HbA1c? Is Bofanglutide (GZR18) safe and well tolerated in the study population? Can participants achieve glycemic targets and improve metabolic outcomes during treatment?

Researchers will compare participants receiving Bofanglutide (GZR18) with participants receiving Semaglutide to evaluate their effects on glycemic control, metabolic outcomes, safety, quality of life, and treatment satisfaction.

Participants will:

Be randomly assigned in a 1:1 ratio to receive Bofanglutide (GZR18) or Semaglutide.

Continue stable metformin monotherapy during the study. Receive subcutaneous study treatment with dose escalation according to the study protocol.

Participate in 30 weeks of active treatment. Attend scheduled study visits, laboratory assessments, and safety evaluations. Complete questionnaires related to quality of life and treatment satisfaction.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

BIOLOGICAL

Bofanglutide

Long-acting GLP-1 receptor agonist administered as a subcutaneous injection every two weeks with dose escalation from 1.5 mg up to 18 mg according to the study protocol.

BIOLOGICAL

Semaglutide

GLP-1 receptor agonist administered as a weekly subcutaneous injection with dose escalation from 0.25 mg up to 1 mg according to the study protocol.

Sponsors & Collaborators

  • Carnot Laboratories

    lead INDUSTRY

Principal Investigators

  • Sergio César Hernández Jiménez, Dr. · Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Centro de Atención Integral del Paciente con Diabetes (CAIPaDi)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628985 on ClinicalTrials.gov