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Type 2 Diabetes Mellitus (T2DM)Phase 3NCT07628985

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

A Phase 3 study testing Bofanglutide and Semaglutide in people with Type 2 Diabetes Mellitus (T2DM), run by Carnot Laboratories at 7 sites in Mexico.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Bofanglutide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
374 participants
Where
7 sitesMexico
Study dates
Sep 2026to Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • Known or suspected hypersensitivity to GLP-1 type drugs or any of their excipients; or presence of contraindications for this type of medication.
  • Participation in clinical trials of other drugs or devices and having received treatment within the 3 months prior to the screening period.
  • Conditions that may cause significant instability in body weight or glycemic control within the 3 months prior to screening, including, but not limited to:
  • Major surgery or surgical procedures with the potential to significantly alter body weight, intake, absorption, gastric emptying, mobility, or metabolic recovery.
  • Current use of non-antidiabetic medications that affect body weight.
  • Participation in weight loss programs that are not in the maintenance phase.
Show all 39Show fewer
  • Use, initiation, discontinuation, or relevant dose change of concomitant medications that, in the investigator's judgment, may significantly affect glycemic control or body weight, including, but not limited to, chronic systemic glucocorticoids, antipsychotics, antiepileptics, or other drugs with relevant metabolic effects, within the 12 weeks prior to the screening period, or plans to initiate or modify such treatments during the study.
  • History of alcohol or drug abuse, including, but not limited to, amphetamines, benzodiazepines, marijuana, cocaine, methadone, and morphine-like drugs, within the 6 months prior to screening, determined by medical history or positive substance abuse screening test results (urine).
  • Previous antidiabetic treatment with:
  • Insulin for more than 14 consecutive days within the year prior to screening (insulin treatment for gestational diabetes mellitus is not considered under this criterion).
  • GLP-1 receptor agonists within the 6 months prior to screening.
  • DPP-4 inhibitors ≤3 months prior to screening.
  • Use of medications such as growth hormone, or others that, in the investigator's judgment, may affect insulin levels, within the 3 months prior to screening.
  • History of diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma within the 6 months prior to screening.
  • T2DM complications such as proliferative retinopathy or maculopathy that is unstable or has required treatment; severe diabetic neuropathy, intermittent claudication, or diabetic foot within the 6 months prior to screening.
  • Severe hypoglycemia (Grade 3) within the 6 months prior to screening; or ≥3 episodes of hypoglycemia (blood glucose ≤70 mg/dL) within the month prior to screening; or recurrent symptoms related to hypoglycemia.
  • Severe trauma, serious infection, or major surgery that, in the investigator's judgment, may affect glycemic control, within the month prior to screening.
  • Serum calcitonin ≥50 pg/mL during screening.
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2A or 2B (MEN 2A/2B), or diagnosis of other malignant neoplasms within the last 5 years.
  • Uncontrolled hyperthyroidism or hypothyroidism. Subjects who have received stable thyroxine replacement treatment for ≥3 months prior to screening and whose TSH, FT3, and FT4 levels are within normal ranges are exempt from this criterion.
  • History of acute or chronic hepatitis, acute or chronic pancreatitis, symptomatic gallbladder disease (for example, multiple gallstones), pancreatic injury, or other high-risk factors that may predispose to the development of pancreatitis.
  • Uncontrolled arterial hypertension, defined as systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg at screening.
  • History of hospitalization for severe cardiovascular disease (including, among others, acute myocardial infarction, unstable angina, cerebrovascular disease, or peripheral vascular disease) or sequelae of cerebrovascular disease within the 6 months prior to screening; presence of a cardiac pacemaker, second/third-degree atrioventricular block, long QT syndrome, QTc ≥450 ms on 12-lead ECG without pacemaker; NYHA class III or IV heart failure; or any other clinically significant cardiac abnormality that, in the investigator's judgment, makes the subject unsuitable for the study.
  • Clinically significant hematologic disorders or any condition that may affect erythrocyte half-life or stability, and therefore interfere with interpretation of glycated hemoglobin (HbA1c), including, but not limited to, aplastic anemia, myelodysplastic syndrome, thalassemia, sickle cell anemia, hemolytic anemia, or any disease causing hemolysis or erythrocyte instability (including malaria or Henoch-Schönlein purpura). Likewise, blood donation or blood loss >400 mL or blood transfusion within the 3 months prior to screening.
  • Clinically significant gastric emptying abnormalities (for example, gastric outlet obstruction), severe chronic gastrointestinal disorders (for example, active ulcers within the last 6 months), prolonged use of drugs that directly affect gastrointestinal motility (including, but not limited to, domperidone, mosapride, cisapride), or gastrointestinal surgery within the 6 months prior to screening, which, in the investigator's judgment, make the subject unsuitable to participate in the study.
  • Clinically significant laboratory abnormalities, including:
  • ALT or AST ≥2.5 times the upper limit of normal (ULN).
  • Fasting triglycerides >500 mg/dL.
  • Amylase and/or lipase ≥1.5 times the ULN.
  • Fasting blood glucose >270 mg/dL.
  • Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m².
  • Evidence of clinically relevant active infection at screening, defined as:
  • Hepatitis B virus (HBV): positive surface antigen (HBsAg) accompanied by detectable viral load (HBV DNA above the laboratory lower limit of detection).
  • Hepatitis C virus (HCV): positive antibodies with detectable viral load (HCV RNA above the laboratory lower limit of detection). Subjects with resolved infection (documented negative RNA) may be included.
  • Human immunodeficiency virus (HIV): confirmed infection with clinical impact or unstable treatment that, in the investigator's judgment, may interfere with subject safety or study participation.
  • Treponema pallidum: positive serology confirmed as active infection by confirmatory tests.
  • History of organ transplantation, or acquired or congenital immune system disorders.
  • Previous history of psychiatric disorders such as schizophrenia, bipolar disorder, previous suicidal tendency, etc., or use of psychiatric medications that, in the investigator's judgment, may interfere with subject participation in the study or protocol compliance.
  • Any clinical condition or circumstance that, in the investigator's judgment, may compromise subject safety, protocol compliance, or the validity and interpretability of study data.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gisselle Vanessa González Hernández, MD contact

+52 5543705748

gvgonzalez@carnot.com

7 sites in 1 country

Mexico7 sites

  • Instituto Jalisciense de Investigación en Diabetes y Obesidad, S.C.

    Guadalajara, Jalisco, 44600

    Guillermo González Gálvez, Dr., 52 3311991124, doctorggg@gmail.com

  • Arechavaleta Granell Maria del Rosario Consultorio de Medicina Especializada

    Guadalajara, Jalisco, 44650

    María del Rosario Arechavaleta Granell, Dr., 52 3313067135, r_arechavaletag@yahoo.com.mx

  • Private Practice

    Mexico City, Cuauhtémoc, 06700

    José Héctor Sánchez Mijangos, Dr., 55 55 5513 7084, hsanchezmijangos@gmail.com

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

    Mexico City, 14080

    Roopa Pravin Mehta, Dr., 52 55 5487 0900 ext. 2405 and 2407, mehta.roopa@incmnsz.mx

  • Universidad Autónoma de Nuevo Leon. Facultad de Medicina

    Monterrey, Nuevo León, 64460

    Fernando Javier Lavalle González, Dr., 55, drfernandolavalle@hotmail.com

  • Oaxaca Site Management Organization, S.C.

    Oaxaca City, Oaxaca, 68000

    Gabriela Vicente Flores, Dr., 52 9515147056, gabriela_vicente@oax.redosmo.com

  • Asociación Mexicana para la Investigación Clínica A.C. AMIC

    Pachuca, Hidalgo, 42082

    Ramiro Alberto Balderas Sánchez, Dr., 52 7717137453, ramirobalderas15@gmail.com

Other trials in Mexico

About this study

Official title: BALANCE-DM2: A Multiregional, Randomized, Multicenter, Active-Controlled Confirmatory Phase III Study to Evaluate the Efficacy and Safety of Bofanglutide (GZR18) in Latin American Adults With Type 2 Diabetes Mellitus

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?

Read more

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.

Being tested
Bofanglutide, Semaglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BofanglutideBiological

    Also called GZR18

    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.

  • SemaglutideBiological

    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 groups in NCT07628985
Study groupRoleWhat they receive
Arm 1: Bofanglutide (GZR18)ExperimentalParticipants 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.
Receives: Biological: Bofanglutide
Arm 2: SemaglutideActive comparatorParticipants will receive Semaglutide administered as a weekly subcutaneous injection with dose escalation according to the study protocol, while continuing stable metformin monotherapy.
Receives: Biological: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hemoglobin A1c (HbA1c) From Baseline at Week 30

    Evaluation of the change in Hemoglobin A1c (HbA1c), expressed as percentage (%), from baseline to Week 30 during treatment

    Measured: Baseline to Week 30

Secondary outcomes (6)

  1. Proportion of Participants Achieving Glycemic Targets (HbA1c <7.0% and ≤6.5%) at Week 30

    To evaluate the proportion of participants achieving glycemic targets of HbA1c <7.0% and ≤6.5% at Week 30 following treatment with Bofanglutide (GZR18) or Semaglutide.

    Measured: Baseline to Week 30

  2. Change in Fasting Plasma Glucose From Baseline at Week 30

    Evaluation of the change in fasting plasma glucose concentration from baseline to Week 30 during treatment

    Measured: Baseline to Week 30

  3. Change in Hemoglobin A1c (HbA1c) From Baseline at Week 16

    Evaluation of the change in Hemoglobin A1c (HbA1c) from baseline to Week 16 during treatment

    Measured: Baseline to Week 16

  4. Change in Body Weight From Baseline at Week 30

    Evaluation of the change in body weight, expressed in kilograms (kg), from baseline to Week 30 during treatment.

    Measured: Baseline to Week 30

  5. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Total Score From Baseline at Week 33

    Evaluation of the change in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) total score from baseline to Week 30 during treatment

    Measured: Baseline to Week 30

  6. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Total Score From Baseline at Week 30

    Evaluation of the change in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) total score from baseline to Week 30 during treatment

    Measured: Baseline to Week 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
374 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07628985
Sponsor's protocol ID
PC-ECI-CM-101-2026
Status last verified
Jun 2026
First submitted
24 May 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data collected during the study will not be made available to other researchers.

Publications

  • 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.

    PubMed 35718129

  • 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.

    PubMed 40028667

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bofanglutide and Semaglutide in people with Type 2 Diabetes Mellitus (T2DM), run by Carnot Laboratories at 7 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gisselle Vanessa González Hernández, MD (+52 5543705748, gvgonzalez@carnot.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin A1c (HbA1c) From Baseline at Week 30 (time frame: Baseline to Week 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07628985, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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