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El ensayo clínico NCT07493057 para Apnea Obstructiva del Sueño (AOS) está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Not Treated With Positive Airway Pressure (PAP) Therapy Fase III 140 Aleatorizado Doble ciego Controlado con placebo

Aún no recluta
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El ensayo clínico NCT07493057 está diseñado para estudiar el tratamiento de Apnea Obstructiva del Sueño (AOS). Este es un estudio intervencionista de Fase III. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 27 de abril de 2026 hasta completar 140 participantes. Dirigido por Gan & Lee Pharmaceuticals., se espera que finalice el 14 de noviembre de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea who are unable or unwilling to undergo positive airway pressure (PAP) therapy.
Título oficial

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea（OSA） Not Treated With Positive Airway Pressure（PAP）

Condiciones médicas
Apnea Obstructiva del Sueño (AOS)
Otros ID del estudio
  • GZR18-OSA-301
Número del NCT
NCT07493057
Inicio del estudio (real)
2026-04-27
Última actualización
2026-03-27
Fecha de finalización (estimada)
2027-11-14
Inscripción (prevista)
140
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Aún no recluta
Palabras clave
obesity
obstructive sleep apnea
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Doble ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalGZR18 injection
GZR18 injection
subcutaneous administration
Comparador placeboPlacebo
PLACEBO
subcutaneous administration
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Change from baseline in Apnea-Hypopnea Index (AHI) after 52 weeks of treatment
52 weeks
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Percentage change in AHI from baseline
52weeks
Proportion of participants with ≥50% reduction in AHI from baseline
52 weeks
Proportion of participants achieving the following criteria：AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10
52 weeks
Percentage change in body weight from baseline
52 weeks
Proportion of subjects whose body weight decreased by ≥ 5%, ≥ 10%, ≥ 15%, or ≥ 20% relative to baseline
52 weeks
Change in body weight (kg) and body mass index (kg/㎡) relative to baseline
52 weeks
Change in neck circumference and waist circumference relative to the baseline
52 weeks
Change in high-sensitivity C-reactive protein (hsCRP) relative to baseline
52 weeks
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos

  1. Subject is aged ≥18 years at the time of signing the informed consent form.

  2. Body mass index (BMI) is ≥28 kg/m² at both screening and randomization.

  3. Subject has a documented history of at least one unsuccessful attempt at weight loss through dietary control prior to screening, and has had <5% change in body weight during the 12 weeks prior to screening.

  4. Subject has been diagnosed with obstructive sleep apnea (OSA) , and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events/hour on polysomnography (PSG) at screening.

  5. Unable or unwilling to receive PAP therapy before screening, and not planning to initiate PAP therapy during the study period.

    -

  1. Known or suspected hypersensitivity to glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or any of their excipients, or presence of a contraindication to GLP-1 RA use.
  2. History of any type of diabetes mellitus (history of gestational diabetes is permitted).
  3. Has undergone or plans to undergo during the study period surgical or device-based obesity treatment (exceptions: acupuncture, liposuction, or abdominal fat removal performed >1 year prior to screening; prior device-based obesity treatment is acceptable if the device was removed >1 year before screening).
  4. Secondary obesity due to disease, medication, or other causes (e.g., Cushing's syndrome, Prader-Willi syndrome, monogenic obesity, or obesity secondary to hypothalamic/pituitary injury).
  5. Clinically significant gastric emptying disorders at screening (e.g., gastroparesis or gastric outlet obstruction); or long-term use (≥4 consecutive weeks) of medications affecting gastrointestinal motility within 6 months prior to screening.
  6. History of acute or chronic pancreatitis or pancreatic injury prior to screening.
  7. History of symptomatic gallbladder disease at screening (post-cholecystectomy status is permitted); or presence at screening of cholelithiasis conferring high risk for acute biliary pancreatitis.
  8. Clinical or subclinical thyrotoxicosis at screening, regardless of treatment status.
  9. Inadequately controlled blood pressure at screening or randomization: systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg (concurrent antihypertensive therapy is permitted).
  10. History within 6 months prior to screening of: decompensated heart failure (NYHA Class III-IV), unstable angina, myocardial infarction, ischemic or hemorrhagic stroke (lacunar infarcts excluded), transient ischemic attack; or invasive cardiovascular procedures/therapies (e.g., valve replacement, CABG, PCI). (Diagnostic coronary angiography without intervention is permitted.)
  11. Positive response on the Columbia-Suicide Severity Rating Scale (C-SSRS) Screening Version to Question 4 or 5 of the "Suicidal Ideation" section, or any question in the "Suicidal Behavior" section, with the event occurring within 4 weeks prior to screening; or investigator assessment of significant suicide risk during the study.
  12. History of moderate-to-severe depression; or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening.
  13. Any uncontrolled acute or chronic hepatitis other than metabolic dysfunction-associated fatty liver disease (MAFLD).
  14. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) type 2A or 2B.
  15. History of malignancy within 5 years prior to screening (exceptions: definitively cured in situ carcinomas, e.g., basal/squamous cell skin cancer, cervical in situ carcinoma, or prostate in situ carcinoma).
Gan & Lee Pharmaceuticals. logoGan & Lee Pharmaceuticals.
Contactos centrales del estudio
Contacto: na ou, 15288850128, [email protected]
1 Centros del estudio en 1 países
Gan & Lee Pharmaceuticals, Beijing, China
na ou, Contacto, 15288850128, [email protected]