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

Korábbi kezelés

• 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.
• Previous diagnosis of diabetes mellitus (except gestational diabetes).
• History of severe hypoglycemia within 6 months prior to screening.
• 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.

Más betegség

• 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.
• 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.
• Any condition that, in the Investigator's judgment, may compromise participant safety, protocol compliance, or the validity of study results.

Laborértékek

• 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.

• 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.