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Clinical Trials in India / NCT07219173
Recruiting Phase 2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173 · tracked via the Priya Life Science India tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2025-10-22
Last updated
2026-08-21

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

BrenipatideBrenipatidePlacebo

Brenipatide: Administered SC

Brenipatide: Administered SC

Placebo: Administered SC

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (121)

FacilityCityRegionStatus
AMR Clinical Tempe Arizona Recruiting
NewportNativeMD, Inc. Newport Beach California Recruiting
California Medical Research Associates Northridge California Recruiting
Peninsula Research Associates Rolling Hills Estates California Recruiting
Asthma & Allergy Associates - Colorado Springs Colorado Springs Colorado Recruiting
AMR Clinical Doral Florida Recruiting
Renstar Medical Research Ocala Florida Recruiting
Avanza Medical Research Center Pensacola Florida Recruiting
USF Health Tampa Florida Recruiting
Axis Clinical Trials - Westchester Westchester Illinois Recruiting
Allergy & Asthma Specialists, P.S.C. Owensboro Kentucky Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
AMR Clinical Las Vegas Nevada Recruiting
Equity Medical New York New York Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
Allergy and Clinical Immunology Associates Pittsburgh Pennsylvania Recruiting
Vanderbilt Asthma, Sinus and Allergy Program Nashville Tennessee Not Yet Recruiting
Consultorios Médicos, Organización del Buen Ayre S.R.L. Buenos Aires Argentina Recruiting
Centro de Investigaciones Metabólicas (CINME) Buenos Aires Argentina Recruiting
Fundación Respirar Buenos Aires Argentina Recruiting
IDIM - Instituto de Investigaciones Metabólicas Ciudad de Buenos Aires Argentina Recruiting
Instituto de Asma, Alergia y Enfermedades Respiratorias Corrientes Argentina Recruiting
Centro de Investigaciones Clínicas Baigorria Granadero Baigorria Argentina Recruiting
Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Argentina Recruiting
Instituto Médico Río Cuarto Río Cuarto Argentina Recruiting
ABC Instituto de Diagnóstico Rosario Argentina Recruiting
Ibamedica Santa Fe Argentina Recruiting
NewData Clinical Research - Aracaju Aracaju Brazil Recruiting
Private Practice - Dr. Nelson Rosário Curitiba Brazil Recruiting
Clinica de Pneumologia Goiânia Brazil Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM Marília Brazil Recruiting
Hospital Universitário Onofre Lopes Natal Brazil Recruiting
Instituto Atena de Pesquisa Clinica Natal Brazil Recruiting
Instituto Méderi de Pesquisa e Saúde Passo Fundo Brazil Recruiting
Hospital de Clínicas de Ribeirão Preto Ribeirão Preto Brazil Recruiting
IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro Brazil Recruiting
Clinica de Alergia Martti Antila Sorocaba Brazil Recruiting
Dynamic Drug Advancement Ajax Canada Recruiting
Heritage Medical Research Clinic Calgary Canada Not Yet Recruiting
St. Joseph's Healthcare Hamilton Hamilton Canada Not Yet Recruiting

+ 81 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07219173 on ClinicalTrials.gov ↗ ← All trials in India