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

NCT07628985 | Not Yet Recruiting Phase 3

• 1 other identifier: PC-ECI-CM-101-2026
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (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

  Baseline to Week 30

Secondary Outcomes (6)

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

  Baseline to Week 30

• Change in Fasting Plasma Glucose From Baseline at Week 30

  Baseline to Week 30

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

  Baseline to Week 16

• Change in Body Weight From Baseline at Week 30

  Baseline to Week 30

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

  Baseline to Week 30

Study Arms (2)

Arm 1: Bofanglutide (GZR18)

EXPERIMENTAL

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.

Biological: Bofanglutide

Arm 2: Semaglutide

ACTIVE COMPARATOR

Participants will receive Semaglutide administered as a weekly subcutaneous injection with dose escalation according to the study protocol, while continuing stable metformin monotherapy.

Biological: Semaglutide

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.

Also known as: GZR18

Arm 1: Bofanglutide (GZR18)

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.

Arm 2: Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Carnot Laboratories: lead

Study Sites (7)

Private Practice

Mexico City, Cuauhtémoc, 06700, Mexico

Location

Asociación Mexicana para la Investigación Clínica A.C. AMIC

Pachuca, Hidalgo, 42082, Mexico

Location

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

Guadalajara, Jalisco, 44600, Mexico

Location

Arechavaleta Granell Maria del Rosario Consultorio de Medicina Especializada

Guadalajara, Jalisco, 44650, Mexico

Location

Universidad Autónoma de Nuevo Leon. Facultad de Medicina

Monterrey, Nuevo León, 64460, Mexico

Location

Oaxaca Site Management Organization, S.C.

Oaxaca City, Oaxaca, 68000, Mexico

Location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

Mexico City, 14080, Mexico

Location

Related Publications (2)

• 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.

  PMID: 35718129 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.

  PMID: 40028667 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sergio César Hernández Jiménez, Dr.

  Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Centro de Atención Integral del Paciente con Diabetes (CAIPaDi)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gisselle Vanessa González Hernández, MD

CONTACT

+52 5543705748; gvgonzalez@carnot.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (7)