A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07219173Tipo: INTERVENTIONALInicio: 22 de oct de 2025Fin estimado: 1 de jun de 2028

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma. Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.
Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.
History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.

Criterios de exclusión

Participants are excluded from the study if any of the following criteria apply:
An established diagnosis of occupational asthma
Known pre-existing, clinically important lung condition other than asthma, including but not limited to:
chronic respiratory infection
bronchiectasis
pulmonary fibrosis
allergic bronchopulmonary aspergillosis
emphysema
chronic bronchitis
eosinophilic granulomatosis with polyangiitis
chronic obstructive pulmonary disease, and
other mimics of asthma, that is, vocal cord dysfunction.
Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.

Intervenciones

drug

Brenipatide

Administered SC

drug

Brenipatide

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Consultorios Médicos, Organización del Buen Ayre S.R.L.

Buenos Aires, Argentina

NOT_YET_RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

NOT_YET_RECRUITING

Fundación Respirar

Buenos Aires, Argentina

NOT_YET_RECRUITING

IDIM - Instituto de Investigaciones Metabólicas

Ciudad de Buenos Aires, Argentina

NOT_YET_RECRUITING

Instituto de Asma, Alergia y Enfermedades Respiratorias

Corrientes, Argentina

NOT_YET_RECRUITING

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Argentina

NOT_YET_RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Argentina

NOT_YET_RECRUITING

Instituto Médico Río Cuarto

Río Cuarto, Argentina

NOT_YET_RECRUITING

ABC Instituto de Diagnóstico

Rosario, Argentina

NOT_YET_RECRUITING

Ibamedica

Santa Fe, Argentina

NOT_YET_RECRUITING

Patrocinadores

PrincipalEli Lilly and Company

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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