Obesity & OverweightPhase 3NCT07622810
BALANCE-OBS: Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity
A Phase 3 study testing Bofanglutida and Semaglutide in people with Obesity & Overweight, run by Carnot Laboratories at 6 sites in Mexico.
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 overweight or obesity. It will also evaluate the effects of treatment on metabolic parameters, cardiovascular risk factors, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Bofanglutida and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 6 sitesMexico
- Study dates
- Sep 2026to Dec 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
- Male or female participants aged ≥18 years.
- Body mass index (BMI): ≥30.0 kg/m² (obesity), or ≥27.0 kg/m² and <30.0 kg/m² (overweight) with at least one weight-related comorbidity, including impaired glucose metabolism, hypertension, dyslipidemia, metabolic dysfunction-associated steatotic liver disease (MASLD), osteoarthritis attributable to excess weight, or obstructive sleep apnea.
- Body weight managed through diet and exercise alone for at least 12 weeks prior to screening, with <5% change in body weight during the previous 12 weeks.
- Willingness and ability to maintain a stable diet and physical activity regimen throughout the study.
- Female participants of reproductive potential must not be pregnant or breastfeeding, must have a negative pregnancy test at screening and prior to randomization, and must agree to use a highly effective method of contraception during the study and for at least 8 weeks after the last dose of study drug.
- Male participants must agree to use effective contraception and refrain from sperm donation during the study and for at least 8 weeks after the last dose of study drug.
- Ability to understand the study requirements and provide written informed consent prior to any study-specific procedures.
Who cannot join
- Known or suspected hypersensitivity to GLP-1 receptor agonists, GLP-1/GIP receptor agonists, or any component of the investigational product.
- History of substance abuse or alcoholism within 6 months prior to screening.
- Presence of conditions that may interfere with accurate anthropometric assessments.
- History of bariatric surgery or planned bariatric surgery during the study.
- Obesity secondary to an underlying disease or medication.
- Previous diagnosis of diabetes mellitus (except gestational diabetes).
Show all 18Show fewer
- History of severe hypoglycemia within 6 months prior to screening.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2).
- History of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer or carcinoma in situ.
- Clinically significant thyroid disease, pancreatitis, gallbladder disease, gastrointestinal disease, cardiovascular disease, cerebrovascular disease, hepatic disease, renal disease, or hematologic disease that, in the Investigator's judgment, may interfere with study participation.
- Uncontrolled hypertension or clinically significant electrocardiogram abnormalities.
- Moderate or severe psychiatric disorders, clinically significant eating disorders, suicidal ideation or behavior, or a PHQ-9 score ≥15 at screening.
- Clinically significant laboratory abnormalities at screening, including abnormalities in liver function, renal function, pancreatic enzymes, calcitonin, hematology, glycemic parameters, or positive testing for HIV, active hepatitis B, hepatitis C, or syphilis.
- Prior use of GLP-1 receptor agonists, dual/triple incretin agonists, weight-loss medications, hypoglycemic agents, or other medications that may affect body weight within 3 months prior to screening.
- Acute infection requiring systemic treatment at screening or prior to randomization.
- Participation in another interventional clinical trial within 90 days or 5 half-lives of the investigational product (whichever is longer) prior to randomization.
- History of organ transplantation, major surgery, or severe trauma within 6 months prior to screening.
- Any condition that, in the Investigator's judgment, may compromise participant safety, protocol compliance, or the validity of study results.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Mexico6 sites
Centro de Estudios de lnvestigación Metabólicos y Cardiovasculares, S.C.
Ciudad Madero, Tamaulipas, 89440
Rafael Margarito Violante Ortiz, Dr., 52 833 126 00 55, dr.violante.cei@hotmail.com
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Guadalajara, Jalisco, 44340
Luis Miguel Román Pintos, Dr., 52 33 986 9435, luis.roman@academicos.udg.mx
Investigación Médica Sonora S.C.
Hermosillo, Sonora, 83280
Diego Espinoza Peralta, Dr., 55 662 212 5596, dr.espinoza.peralta@gmail.com
Instituto Nacional de Cardiología "Ignacio Chávez"
Mexico City, 14080
Diego Araiza Garaygordobil, Dr., 52 55 5573 2911 ext. 27303, dargaray@gmail.com
CICMEX Centro de Investigación Clínica de México S de RL de CV.
Morelia, Michoacán, 58000
Armando Benítez Cabrera, Dr., 52 443 298 9405, drarmandobenitezcabrera@gmail.com
SMIQ, S. de R.L. de C.V.
Querétaro City, Querétaro, 76070
Juan Carlos Márquez Romero, Dr., 55 442 224 7516, jcmmdm@gmil.com
About this study
Official title: BALANCE-OBS: A Multiregional, Randomized, Multicenter, Active-Controlled Confirmatory Phase III Study to Evaluate the Efficacy and Safety of Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity
The goal of this clinical trial is to evaluate the efficacy and safety of Bofanglutide (GZR18) compared with Semaglutide in Latin American adults with overweight or obesity. It will also evaluate the effects of treatment on metabolic parameters, cardiovascular risk factors, and quality of life.
The main questions it aims to answer are:
Read more
Does Bofanglutide (GZR18) reduce body weight after 36 weeks of treatment compared with Semaglutide? What effects does Bofanglutide (GZR18) have on metabolic parameters, cardiovascular risk factors, and quality of life? How safe and well tolerated is treatment with Bofanglutide (GZR18)?
Researchers will compare Bofanglutide (GZR18) with Semaglutide, an active comparator, to evaluate efficacy and safety in adults with overweight or obesity.
Participants will:
Receive Bofanglutide (GZR18) every 2 weeks or Semaglutide once weekly by subcutaneous injection Follow standardized recommendations for diet and physical activity throughout the study Attend scheduled clinic visits for efficacy and safety assessments Participate in treatment and follow-up for up to 40 weeks, including screening, treatment, and safety follow-up periods
- Conditions
- Obesity & Overweight
- Being tested
- Bofanglutida, Semaglutide
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BofanglutidaDrug
Also called GZR18
Bofanglutide (GZR18) is a long-acting GLP-1 receptor agonist administered by subcutaneous injection every 2 weeks. Participants will receive progressive dose titration starting at 3 mg up to a target dose of 48 mg according to the study protocol during the 36-week treatment period.
SemaglutideDrug
Semaglutide is a GLP-1 receptor agonist administered by weekly subcutaneous injection with progressive dose titration from 0.25 mg to 1 mg according to the study protocol during the 36-week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Bofanglutida (GZR18), | Experimental | Not described Receives: Drug: Bofanglutida |
| Group B: Semaglutide | Active comparator | Not described Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight From Baseline to Week 36
Evaluation of the percent change in body weight from baseline to Week 36 in participants receiving Bofanglutide (GZR18) compared with Semaglutide.
Measured: Baseline to Week 36
Secondary outcomes (14)
Proportion of Participants Achieving Clinically Relevant Weight Reduction
Evaluation of the proportion of participants achieving clinically relevant body weight reductions of ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from baseline to Week 36.
Measured: Baseline to Week 36
Change in Body Mass Index (BMI) From Baseline at Week 36
Evaluation of the change in body mass index (BMI), expressed in kg/m², from baseline to Week 36 during treatment
Measured: Baseline to Week 36
Change in Hemoglobin A1c (HbA1c) From Baseline at Week 36
Evaluation of the change in glycated hemoglobin (HbA1c), expressed as percentage (%), from baseline to Week 36 during treatment
Measured: Baseline to Week 36
Change in Fasting Plasma Glucose From Baseline at Week 36
Evaluation of the change in fasting plasma glucose concentration from baseline to Week 36 during treatment
Measured: From Baseline at Week 36
Change in Systolic Blood Pressure From Baseline at Week 36
Evaluation of the change in systolic blood pressure from baseline to Week 36 during treatment
Measured: Baseline to Week 36
Change in Diastolic Blood Pressure From Baseline at Week 36
Evaluation of the change in diastolic blood pressure from baseline to Week 36 during treatment
Measured: Baseline to Week 36
Change in Total Cholesterol From Baseline at Week 36
Evaluation of the change in total cholesterol concentration from baseline to Week 36 during treatment
Measured: Baseline to Week 36
Change in Triglycerides From Baseline at Week 36
Evaluation of the change in fasting triglyceride concentration from baseline to Week 36 during treatment
Measured: Baseline to Week 36
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score From Baseline at Week 36
Evaluation of the change in the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score from baseline to Week 36 during treatment. Scores range from 0 to 100, with higher scores indicating better weight-related quality of life.
Measured: Baseline to Week 36
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Evaluation of safety and tolerability based on adverse events, serious adverse events, laboratory assessments, and treatment discontinuations during the study.
Measured: From first dose through safety follow-up (up to 40 weeks)
Change in Patient Health Questionnaire-9 (PHQ-9) Total Score From Baseline at Week 40
Evaluation of the change in the Patient Health Questionnaire-9 (PHQ-9) total score from baseline to Week 40. The PHQ-9 is a self-administered questionnaire used to assess depressive symptoms. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: From first dose through safety follow-up (up to 40 weeks)
Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Evaluation of the occurrence of suicidal ideation or suicidal behavior during treatment with Bofanglutide (GZR18) compared with Semaglutide, assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Measured: From first dose through safety follow-up (up to 40 weeks)
Incidence of Anti-Drug Antibodies Against Bofanglutide
Evaluation of the incidence of anti-drug antibodies (ADAs) against Bofanglutide during the study, including assessment of neutralizing antibodies (NAbs) and cross-reactivity with endogenous glucagon-like peptide-1 (GLP-1), as applicable.
Measured: From first dose through safety follow-up (up to 40 weeks)
Early Assessment at Week 16
Evaluation of the percent change in body weight from baseline and the proportion of participants achieving body weight reductions of ≥5% and ≥10% at Week 16.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carnot Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emma Adriana Chávez Manzanera, Dr., Principal investigator, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Clínica de Obesidad y Trastornos de la Conducta Alimentaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622810
- Sponsor's protocol ID
- PC-ECI-CM-102-2026
- Status last verified
- Jun 2026
- First submitted
- 24 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data collected during this study will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BALANCE-OBS: A Multiregional, Randomized, Multicenter, Active-Controlled Confirmatory Phase III Study to Evaluate the Efficacy and Safety of Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07622810
- Acronym / sponsor ID
- PC-ECI-CM-102-2026
- Conditions
- Obesity & Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Carnot LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy and safety of Bofanglutide (GZR18) compared with Semaglutide in Latin American adults with overweight or obesity. It will also evaluate the effects of treatment on metabolic parameters, cardiovascular risk factors, and quality of life.
The main questions it aims to answer are:
Does Bofanglutide (GZR18) reduce body weight after 36 weeks of treatment compared with Semaglutide? What effects does Bofanglutide (GZR18) have on metabolic parameters, cardiovascular risk factors, and quality of life? How safe and well tolerated is treatment with Bofanglutide (GZR18)?
Researchers will compare Bofanglutide (GZR18) with Semaglutide, an active comparator, to evaluate efficacy and safety in adults with overweight or obesity.
Participants will:
Receive Bofanglutide (GZR18) every 2 weeks or Semaglutide once weekly by subcutaneous injection Follow standardized recommendations for diet and physical activity throughout the study Attend scheduled clinic visits for efficacy and safety assessments Participate in treatment and follow-up for up to 40 weeks, including screening, treatment, and safety follow-up periods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Bofanglutida (GZR18), | Experimental | Drug: Bofanglutida |
| Group B: Semaglutide | Active comparator | Drug: Semaglutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participants aged ≥18 years.
- Body mass index (BMI): ≥30.0 kg/m² (obesity), or ≥27.0 kg/m² and <30.0 kg/m² (overweight) with at least one weight-related comorbidity, including impaired glucose metabolism, hypertension, dyslipidemia, metabolic dysfunction-associated steatotic liver disease (MASLD), osteoarthritis attributable to excess weight, or obstructive sleep apnea.
- Body weight managed through diet and exercise alone for at least 12 weeks prior to screening, with <5% change in body weight during the previous 12 weeks.
- Willingness and ability to maintain a stable diet and physical activity regimen throughout the study.
- Female participants of reproductive potential must not be pregnant or breastfeeding, must have a negative pregnancy test at screening and prior to randomization, and must agree to use a highly effective method of contraception during the study and for at least 8 weeks after the last dose of study drug.
Key exclusion criteria (18 listed)
- Known or suspected hypersensitivity to GLP-1 receptor agonists, GLP-1/GIP receptor agonists, or any component of the investigational product.
- History of substance abuse or alcoholism within 6 months prior to screening.
- Presence of conditions that may interfere with accurate anthropometric assessments.
- History of bariatric surgery or planned bariatric surgery during the study.
- Obesity secondary to an underlying disease or medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BofanglutidaAlso: GZR18Bofanglutide (GZR18) is a long-acting GLP-1 receptor agonist administered by subcutaneous injection every 2 weeks. Participants will receive progressive dose titration starting at 3 mg up to a target dose of 48 mg according to the study protocol during the 36-week treatment period. | Drug | Group A: Bofanglutida (GZR18), |
| SemaglutideSemaglutide is a GLP-1 receptor agonist administered by weekly subcutaneous injection with progressive dose titration from 0.25 mg to 1 mg according to the study protocol during the 36-week treatment period. | Drug | Group B: Semaglutide |
Primary outcome
Percent Change in Body Weight From Baseline to Week 36
Time frame: Baseline to Week 36
Evaluation of the percent change in body weight from baseline to Week 36 in participants receiving Bofanglutide (GZR18) compared with Semaglutide.
14 secondary outcomes
Proportion of Participants Achieving Clinically Relevant Weight Reduction
Time frame: Baseline to Week 36
Change in Body Mass Index (BMI) From Baseline at Week 36
Time frame: Baseline to Week 36
Change in Hemoglobin A1c (HbA1c) From Baseline at Week 36
Time frame: Baseline to Week 36
Change in Fasting Plasma Glucose From Baseline at Week 36
Time frame: From Baseline at Week 36
Change in Systolic Blood Pressure From Baseline at Week 36
Time frame: Baseline to Week 36
Change in Diastolic Blood Pressure From Baseline at Week 36
Time frame: Baseline to Week 36
Change in Total Cholesterol From Baseline at Week 36
Time frame: Baseline to Week 36
Change in Triglycerides From Baseline at Week 36
Time frame: Baseline to Week 36
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score From Baseline at Week 36
Time frame: Baseline to Week 36
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: From first dose through safety follow-up (up to 40 weeks)
Change in Patient Health Questionnaire-9 (PHQ-9) Total Score From Baseline at Week 40
Time frame: From first dose through safety follow-up (up to 40 weeks)
Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From first dose through safety follow-up (up to 40 weeks)
Incidence of Anti-Drug Antibodies Against Bofanglutide
Time frame: From first dose through safety follow-up (up to 40 weeks)
Early Assessment at Week 16
Time frame: Baseline to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data collected during this study will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma Adriana Chávez Manzanera, Dr. principal investigator
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Clínica de Obesidad y Trastornos de la Conducta Alimentaria
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bofanglutida and Semaglutide in people with Obesity & Overweight, run by Carnot Laboratories at 6 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 7 inclusion and 18 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 3 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 6 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, Dr. (52, gvgonzalez@carnot.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight From Baseline to Week 36 (time frame: Baseline to Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.