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

What this study is testing ClinicalTrials.gov NCT07628985 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Bofanglutide also known as GZR18 Biologic

  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.

• Semaglutide Biologic

  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.