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

1 giugno 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

352

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Messico
      • Mexico City, Messico, 14080
        • Instituto Nacional de Cardiología "Ignacio Chávez"
        • Contatto:
          • Diego Araiza Garaygordobil, Dr.
          • Numero di telefono: 27303 52 55 5573 2911
          • Email: dargaray@gmail.com
    • Jalisco
      • Guadalajara, Jalisco, Messico, 44340
        • Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)
        • Contatto:
    • Michoacán
      • Morelia, Michoacán, Messico, 58000
        • CICMEX Centro de Investigación Clínica de México S de RL de CV.
        • Contatto:
    • Querétaro
      • Querétaro City, Querétaro, Messico, 76070
        • SMIQ, S. de R.L. de C.V.
        • Contatto:
          • Juan Carlos Márquez Romero, Dr.
          • Numero di telefono: 55 442 224 7516
          • Email: jcmmdm@gmil.com
    • Sonora
      • Hermosillo, Sonora, Messico, 83280
        • Investigación Médica Sonora S.C.
        • Contatto:
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Messico, 89440
        • Centro de Estudios de lnvestigación Metabólicos y Cardiovasculares, S.C.
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group A: Bofanglutida (GZR18),
Droga: 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.
Altri nomi:
  • GZR18
Comparatore attivo: Group B: Semaglutide
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent Change in Body Weight From Baseline to Week 36
Lasso di tempo: 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.
Baseline to Week 36

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants Achieving Clinically Relevant Weight Reduction
Lasso di tempo: Baseline to Week 36
Evaluation of the proportion of participants achieving clinically relevant body weight reductions of ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from baseline to Week 36.
Baseline to Week 36
Change in Body Mass Index (BMI) From Baseline at Week 36
Lasso di tempo: Baseline to Week 36
Evaluation of the change in body mass index (BMI), expressed in kg/m², from baseline to Week 36 during treatment
Baseline to Week 36
Change in Hemoglobin A1c (HbA1c) From Baseline at Week 36
Lasso di tempo: Baseline to Week 36
Evaluation of the change in glycated hemoglobin (HbA1c), expressed as percentage (%), from baseline to Week 36 during treatment
Baseline to Week 36
Change in Fasting Plasma Glucose From Baseline at Week 36
Lasso di tempo: From Baseline at Week 36
Evaluation of the change in fasting plasma glucose concentration from baseline to Week 36 during treatment
From Baseline at Week 36
Change in Systolic Blood Pressure From Baseline at Week 36
Lasso di tempo: Baseline to Week 36
Evaluation of the change in systolic blood pressure from baseline to Week 36 during treatment
Baseline to Week 36
Change in Diastolic Blood Pressure From Baseline at Week 36
Lasso di tempo: Baseline to Week 36
Evaluation of the change in diastolic blood pressure from baseline to Week 36 during treatment
Baseline to Week 36
Change in Total Cholesterol From Baseline at Week 36
Lasso di tempo: Baseline to Week 36
Evaluation of the change in total cholesterol concentration from baseline to Week 36 during treatment
Baseline to Week 36
Change in Triglycerides From Baseline at Week 36
Lasso di tempo: Baseline to Week 36
Evaluation of the change in fasting triglyceride concentration from baseline to Week 36 during treatment
Baseline to Week 36
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score From Baseline at Week 36
Lasso di tempo: Baseline to Week 36
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.
Baseline to Week 36
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Lasso di tempo: From first dose through safety follow-up (up to 40 weeks)
Evaluation of safety and tolerability based on adverse events, serious adverse events, laboratory assessments, and treatment discontinuations during the study.
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
Lasso di tempo: From first dose through safety follow-up (up to 40 weeks)
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.
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)
Lasso di tempo: From first dose through safety follow-up (up to 40 weeks)
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).
From first dose through safety follow-up (up to 40 weeks)
Incidence of Anti-Drug Antibodies Against Bofanglutide
Lasso di tempo: From first dose through safety follow-up (up to 40 weeks)
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.
From first dose through safety follow-up (up to 40 weeks)
Early Assessment at Week 16
Lasso di tempo: Baseline to Week 16
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.
Baseline to Week 16

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Carnot Laboratories

Investigatori

  • Investigatore principale: Emma Adriana Chávez Manzanera, Dr., Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Clínica de Obesidad y Trastornos de la Conducta Alimentaria

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

24 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PC-ECI-CM-102-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

De-identified individual participant data collected during this study will not be made available to other researchers.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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