Last updated 8 days ago
BALANCE-OBS: Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity
352 patients around the world
Available in Mexico
Carnot Laboratories
3Research sites
352Patients around the world
This study is for people with
Obesity
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.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.
Sites
Instituto Nacional de Cardiologia Ignacio Chavez
Centro de Investigación Clínica y Medicina Traslacional CIMeT
Centro de Estudios de Investigación Metabólica y Cardiovascular SC
SponsorCarnot Laboratories
Study typeInterventional
Conditions
Obesity
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07622810
