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

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.

Timeline

Start

2026-09

Primary completion

2027-10

Completion

2027-10

Publications

• Background Zhang M, Zhang Y, Peng X, He A, Wang Y, Deng Y, Cui C, Xue F, Wei B, Xing W, Qian Y, Mazuranic M, Chen W. GZR18, a novel long-acting GLP-1 analog, demonstrated positive in vitro and in vivo pharmacokinetic and pharmacodynamic characteristics in animal models. Eur J Pharmacol. 2022 Aug 5;928:175107. doi: 10.1016/j.ejphar.2022.175107. Epub 2022 Jun 16.
• Background Liu Y, Chen W, He X, He A, Zhao L, Xie T, Li Y, Zhao J, Hunt A, Shi A, Gan ZR. The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects. Diabetes Obes Metab. 2025 May;27(5):2777-2789. doi: 10.1111/dom.16285. Epub 2025 Mar 3.

Drugs

Indications