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

Sponsor
Carnot Laboratories
Study ID
NCT07628985
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bofanglutide — BIOLOGICAL
    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 — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
374 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Bofanglutide (GZR18)
    Participants will receive Bofanglutide (GZR18) administered as a subcutaneous injection every two weeks with dose escalation according to the study protocol, while continuing stable metformin monotherapy.
  • Active Comparator: Arm 2: Semaglutide
    Participants will receive Semaglutide administered as a weekly subcutaneous injection with dose escalation according to the study protocol, while continuing stable metformin monotherapy.

Primary Outcome Measure

Change in Hemoglobin A1c (HbA1c) From Baseline at Week 30 [ Time Frame: Baseline to Week 30 ]

Central Contacts

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