BALANCE-DM2 Study of Bofanglutide in Adults With Type 2 Diabetes (NCT07628985) | Clinical Trial Compass
Not Yet RecruitingPhase 3
BALANCE-DM2 Study of Bofanglutide in Adults With Type 2 Diabetes
Mexico374 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years and older who agree to participate in the study by voluntarily signing the Informed Consent Form.
* Adult participants of either male or female sex.
* Diagnosis of type 2 diabetes mellitus (T2DM) with a duration greater than 6 months, established according to the diagnostic and classification criteria for diabetes mellitus of the World Health Organization (WHO) in 1999, as well as the supplementary WHO diagnostic criteria of 2011, and in accordance with the widely accepted clinical criteria of the American Diabetes Association.
* Background treatment with metformin monotherapy, at a stable dose for at least 90 days prior to screening, at a dose ≥1500 mg/day or at the maximum tolerated dose (MTD; ≥1000 mg/day), with no planned changes during the study.
* HbA1c determined by central laboratory during the screening period ≥7.0% and ≤10.5%.
* Fasting plasma glucose (FPG) during screening \<270 mg/dL.
* Body mass index (BMI) ≥27 kg/m².
* Stable body weight prior to screening, defined as a change ≤5% in body weight during the previous 3 months.
* Women of childbearing potential must have a negative pregnancy test during screening and at the baseline visit; must not be breastfeeding; must have no plans for pregnancy from signing the ICF until 6 months after the last dose of study treatment; and must agree to use effective contraceptive methods during this period.
Men must have no plans for sperm donation during the same period.
Exclusion…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing bofanglutide, which I'm not familiar with — can you tell me what class of drug it is, how it works for Type 2 diabetes, and how it compares to treatments I might already be on or considering?
2The trial is Phase 3, which means it's a later-stage study — does that mean there's already a reasonable amount of safety data from earlier phases that we can review before I consider whether to discuss enrollment with you?
3The trial isn't recruiting yet — given that timing, is it worth waiting to see if this becomes available, or would starting a proven standard-of-care treatment now make more sense for where my diabetes management stands today?
4The main thing this trial is measuring is the change in HbA1c over 30 weeks — based on my current HbA1c and overall health picture, do you think a 30-week study focused on that outcome would actually tell us something meaningful about how well my diabetes is being controlled?
5What would participating in a trial like this actually require of me in terms of clinic visits, monitoring, or restrictions over those 30 weeks, and is that realistic given my schedule and support situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Hemoglobin A1c (HbA1c) From Baseline at Week 30