BALANCE-OBS: Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity

NCT07622810 | Not Yet Recruiting Phase 3

• 1 other identifier: PC-ECI-CM-102-2026
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 6

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 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

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 36

Secondary Outcomes (14)

• Proportion of Participants Achieving Clinically Relevant Weight Reduction

  Baseline to Week 36

• Change in Body Mass Index (BMI) From Baseline at Week 36

  Baseline to Week 36

• Change in Hemoglobin A1c (HbA1c) From Baseline at Week 36

  Baseline to Week 36

• Change in Fasting Plasma Glucose From Baseline at Week 36

  From Baseline at Week 36

• Change in Systolic Blood Pressure From Baseline at Week 36

  Baseline to Week 36

Study Arms (2)

Group A: Bofanglutida (GZR18),

EXPERIMENTAL

Drug: Bofanglutida

Group B: Semaglutide

ACTIVE COMPARATOR

Drug: Semaglutide

Interventions

Bofanglutida DRUG

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.

Also known as: GZR18

Group A: Bofanglutida (GZR18),

Semaglutide DRUG

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.

Group B: Semaglutide

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Carnot Laboratories: lead

Study Sites (6)

Centro de Investigación Clínica y Medicina Traslacional (CIMeT)

Guadalajara, Jalisco, 44340, Mexico

Location

CICMEX Centro de Investigación Clínica de México S de RL de CV.

Morelia, Michoacán, 58000, Mexico

Location

SMIQ, S. de R.L. de C.V.

Querétaro City, Querétaro, 76070, Mexico

Location

Investigación Médica Sonora S.C.

Hermosillo, Sonora, 83280, Mexico

Location

Centro de Estudios de lnvestigación Metabólicos y Cardiovasculares, S.C.

Ciudad Madero, Tamaulipas, 89440, Mexico

Location

Instituto Nacional de Cardiología "Ignacio Chávez"

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emma Adriana Chávez Manzanera, Dr.

  Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Clínica de Obesidad y Trastornos de la Conducta Alimentaria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gisselle Vanessa González Hernández, Dr.

CONTACT

52; 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 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (6)