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

1. juni 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

352

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A: Bofanglutida (GZR18),
Medicin: 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.
Andre navne:
  • GZR18
Aktiv komparator: Group B: Semaglutide
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change in Body Weight From Baseline to Week 36
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants Achieving Clinically Relevant Weight Reduction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Carnot Laboratories

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

24. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PC-ECI-CM-102-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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