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

Phase 3Not Yet RecruitingNCT07622810

Carnot Laboratories352 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

352

Conditions

Obesity & Overweight

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.