BALANCE-OBS: Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity
1. června 2026 aktualizováno: Carnot Laboratories
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
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
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
352
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Gisselle Vanessa González Hernández, Dr.
- Telefonní číslo: 52
- E-mail: gvgonzalez@carnot.com
Studijní místa
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Mexico City, Mexiko, 14080
- Instituto Nacional de Cardiología "Ignacio Chávez"
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Kontakt:
- Diego Araiza Garaygordobil, Dr.
- Telefonní číslo: 27303 52 55 5573 2911
- E-mail: dargaray@gmail.com
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Jalisco
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Guadalajara, Jalisco, Mexiko, 44340
- Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)
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Kontakt:
- Luis Miguel Román Pintos, Dr.
- Telefonní číslo: 52 33 986 9435
- E-mail: luis.roman@academicos.udg.mx
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Michoacán
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Morelia, Michoacán, Mexiko, 58000
- CICMEX Centro de Investigación Clínica de México S de RL de CV.
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Kontakt:
- Armando Benítez Cabrera, Dr.
- Telefonní číslo: 52 443 298 9405
- E-mail: drarmandobenitezcabrera@gmail.com
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Querétaro
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Querétaro City, Querétaro, Mexiko, 76070
- SMIQ, S. de R.L. de C.V.
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Kontakt:
- Juan Carlos Márquez Romero, Dr.
- Telefonní číslo: 55 442 224 7516
- E-mail: jcmmdm@gmil.com
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Sonora
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Hermosillo, Sonora, Mexiko, 83280
- Investigación Médica Sonora S.C.
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Kontakt:
- Diego Espinoza Peralta, Dr.
- Telefonní číslo: 55 662 212 5596
- E-mail: dr.espinoza.peralta@gmail.com
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Tamaulipas
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Ciudad Madero, Tamaulipas, Mexiko, 89440
- Centro de Estudios de lnvestigación Metabólicos y Cardiovasculares, S.C.
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Kontakt:
- Rafael Margarito Violante Ortiz, Dr.
- Telefonní číslo: 52 833 126 00 55
- E-mail: dr.violante.cei@hotmail.com
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Group A: Bofanglutida (GZR18),
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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.
Ostatní jména:
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Aktivní komparátor: Group B: Semaglutide
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percent Change in Body Weight From Baseline to Week 36
Časové okno: Baseline to Week 36
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Evaluation of the percent change in body weight from baseline to Week 36 in participants receiving Bofanglutide (GZR18) compared with Semaglutide.
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Baseline to Week 36
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportion of Participants Achieving Clinically Relevant Weight Reduction
Časové okno: Baseline to Week 36
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Evaluation of the proportion of participants achieving clinically relevant body weight reductions of ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from baseline to Week 36.
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Baseline to Week 36
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Change in Body Mass Index (BMI) From Baseline at Week 36
Časové okno: Baseline to Week 36
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Evaluation of the change in body mass index (BMI), expressed in kg/m², from baseline to Week 36 during treatment
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Baseline to Week 36
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Change in Hemoglobin A1c (HbA1c) From Baseline at Week 36
Časové okno: Baseline to Week 36
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Evaluation of the change in glycated hemoglobin (HbA1c), expressed as percentage (%), from baseline to Week 36 during treatment
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Baseline to Week 36
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Change in Fasting Plasma Glucose From Baseline at Week 36
Časové okno: From Baseline at Week 36
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Evaluation of the change in fasting plasma glucose concentration from baseline to Week 36 during treatment
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From Baseline at Week 36
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Change in Systolic Blood Pressure From Baseline at Week 36
Časové okno: Baseline to Week 36
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Evaluation of the change in systolic blood pressure from baseline to Week 36 during treatment
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Baseline to Week 36
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Change in Diastolic Blood Pressure From Baseline at Week 36
Časové okno: Baseline to Week 36
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Evaluation of the change in diastolic blood pressure from baseline to Week 36 during treatment
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Baseline to Week 36
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Change in Total Cholesterol From Baseline at Week 36
Časové okno: Baseline to Week 36
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Evaluation of the change in total cholesterol concentration from baseline to Week 36 during treatment
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Baseline to Week 36
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Change in Triglycerides From Baseline at Week 36
Časové okno: Baseline to Week 36
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Evaluation of the change in fasting triglyceride concentration from baseline to Week 36 during treatment
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Baseline to Week 36
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Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score From Baseline at Week 36
Časové okno: Baseline to Week 36
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Evaluation of the change in the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score from baseline to Week 36 during treatment.
Scores range from 0 to 100, with higher scores indicating better weight-related quality of life.
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Baseline to Week 36
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Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Časové okno: From first dose through safety follow-up (up to 40 weeks)
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Evaluation of safety and tolerability based on adverse events, serious adverse events, laboratory assessments, and treatment discontinuations during the study.
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From first dose through safety follow-up (up to 40 weeks)
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Change in Patient Health Questionnaire-9 (PHQ-9) Total Score From Baseline at Week 40
Časové okno: From first dose through safety follow-up (up to 40 weeks)
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Evaluation of the change in the Patient Health Questionnaire-9 (PHQ-9) total score from baseline to Week 40.
The PHQ-9 is a self-administered questionnaire used to assess depressive symptoms.
Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
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From first dose through safety follow-up (up to 40 weeks)
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Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Časové okno: From first dose through safety follow-up (up to 40 weeks)
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Evaluation of the occurrence of suicidal ideation or suicidal behavior during treatment with Bofanglutide (GZR18) compared with Semaglutide, assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS).
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From first dose through safety follow-up (up to 40 weeks)
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Incidence of Anti-Drug Antibodies Against Bofanglutide
Časové okno: From first dose through safety follow-up (up to 40 weeks)
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Evaluation of the incidence of anti-drug antibodies (ADAs) against Bofanglutide during the study, including assessment of neutralizing antibodies (NAbs) and cross-reactivity with endogenous glucagon-like peptide-1 (GLP-1), as applicable.
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From first dose through safety follow-up (up to 40 weeks)
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Early Assessment at Week 16
Časové okno: Baseline to Week 16
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Evaluation of the percent change in body weight from baseline and the proportion of participants achieving body weight reductions of ≥5% and ≥10% at Week 16.
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Baseline to Week 16
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Emma Adriana Chávez Manzanera, Dr., Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Clínica de Obesidad y Trastornos de la Conducta Alimentaria
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. září 2026
Primární dokončení (Odhadovaný)
1. prosince 2027
Dokončení studie (Odhadovaný)
1. prosince 2027
Termíny zápisu do studia
První předloženo
24. května 2026
První předloženo, které splnilo kritéria kontroly kvality
1. června 2026
První zveřejněno (Aktuální)
3. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
3. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PC-ECI-CM-102-2026
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
De-identified individual participant data collected during this study will not be made available to other researchers.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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