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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Bofanglutida
  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.
• Препарат Semaglutide
  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.

Первичные конечные точки

• Percent Change in Body Weight From Baseline to Week 36 [Срок оценки: Baseline to Week 36]

Вторичные конечные точки (12)

• Proportion of Participants Achieving Clinically Relevant Weight Reduction [Срок оценки: Baseline to Week 36]
• Change in Body Mass Index (BMI) From Baseline at Week 36 [Срок оценки: Baseline to Week 36]
• Change in Hemoglobin A1c (HbA1c) From Baseline at Week 36 [Срок оценки: Baseline to Week 36]
• Change in Fasting Plasma Glucose From Baseline at Week 36 [Срок оценки: From Baseline at Week 36]
• Change in Systolic Blood Pressure From Baseline at Week 36 [Срок оценки: Baseline to Week 36]
• Change in Diastolic Blood Pressure From Baseline at Week 36 [Срок оценки: Baseline to Week 36]
• Change in Total Cholesterol From Baseline at Week 36 [Срок оценки: Baseline to Week 36]
• Change in Triglycerides From Baseline at Week 36 [Срок оценки: Baseline to Week 36]
• Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score From Baseline at Week 36 [Срок оценки: Baseline to Week 36]
• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: From first dose through safety follow-up (up to 40 weeks)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Мексика · 6 центров

• Centro de Investigación Clínica y Medicina Traslacional (CIMeT) — Guadalajara
• CICMEX Centro de Investigación Clínica de México S de RL de CV. — Morelia
• SMIQ, S. de R.L. de C.V. — Querétaro City
• Investigación Médica Sonora S.C. — Hermosillo
• Centro de Estudios de lnvestigación Metabólicos y Cardiovasculares, S.C. — Ciudad Madero
• Instituto Nacional de Cardiología "Ignacio Chávez" — Mexico City

Идентификаторы

NCT: NCT07622810 · PC-ECI-CM-102-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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