RecruitingPhase 2NCT07219173

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

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

Sponsor

Eli Lilly and Company

Enrollment

531 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Asthma

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called brenipatide compared to a placebo (inactive treatment) in adults with moderate to severe asthma that is not well-controlled despite using standard controller medications. The goal is to find out whether brenipatide can better manage asthma symptoms and reduce flare-ups. **You may be eligible if...** - You have been diagnosed with asthma by a doctor and have been on prescribed controller medication for at least 12 months - Your asthma is still not well-controlled (high symptom scores on questionnaires at multiple visits) - You have had at least one severe asthma attack requiring systemic steroids in the past year **You may NOT be eligible if...** - You have occupational asthma (caused specifically by workplace exposures) - You have another lung disease such as COPD, pulmonary fibrosis, chronic bronchitis, or bronchiectasis - You have an active infection within 30 days before starting the study - Your asthma may actually be another condition (like vocal cord dysfunction) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrenipatide

Administered SC

DRUGBrenipatide

Administered SC

DRUGPlacebo

Administered SC

Locations(121)

AMR Clinical

Tempe, Arizona, United States

NewportNativeMD, Inc.

Newport Beach, California, United States

California Medical Research Associates

Northridge, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Asthma & Allergy Associates - Colorado Springs

Colorado Springs, Colorado, United States

AMR Clinical

Doral, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Avanza Medical Research Center

Pensacola, Florida, United States

USF Health

Tampa, Florida, United States

Axis Clinical Trials - Westchester

Westchester, Illinois, United States

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

AMR Clinical

Las Vegas, Nevada, United States

Equity Medical

New York, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

Vanderbilt Asthma, Sinus and Allergy Program

Nashville, Tennessee, United States

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

Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

IDIM - Instituto de Investigaciones Metabólicas

Ciudad de Buenos Aires, Argentina

Instituto de Asma, Alergia y Enfermedades Respiratorias

Corrientes, Argentina

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Argentina

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Argentina

ABC Instituto de Diagnóstico

Rosario, Argentina

Ibamedica

Santa Fe, Argentina

NewData Clinical Research - Aracaju

Aracaju, Brazil

Private Practice - Dr. Nelson Rosário

Curitiba, Brazil

Clinica de Pneumologia

Goiânia, Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, Brazil

Hospital Universitário Onofre Lopes

Natal, Brazil

Instituto Atena de Pesquisa Clinica

Natal, Brazil

Instituto Méderi de Pesquisa e Saúde

Passo Fundo, Brazil

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, Brazil

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, Brazil

Clinica de Alergia Martti Antila

Sorocaba, Brazil

Dynamic Drug Advancement

Ajax, Canada

Heritage Medical Research Clinic

Calgary, Canada

University Of Alberta Hospital

Edmonton, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Canada

Kelowna Health and Memory Centre

Kelowna, Canada

McGill University Health Centre

Montreal, Canada

IUCPQ

Québec, Canada

Richmond Clinical Trials

Richmond, Canada

C.I.C. Saint-Laurent

Saint-Laurent, Canada

Inspiration Research

Toronto, Canada

Dr. Syed Anees Medicine Professional Corporation

Windsor, Canada

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T

Baotou, China

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

West China Hospital, Sichuan University

Chengdu, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Zhejiang Provincial People's Hospital

Hangzhou, China

Jiangxi Provincial People's Hospital

Nanchang, China

Nanjing Medical University - Nanjing Jiangning Hospital

Nanjing, China

Shanghai General Hospital

Shanghai, China

The University of Hong Kong-Shenzhen Hospital

Shenzhen, China

The Second Afilliated Hospital of Hebei Medical University

Shijiazhuang, China

Tianjin Medical University General Hospital

Tianjin, China

The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, China

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence

Aix-en-Provence, France

CHRU de Brest

Brest, France

Centre Hospitalier de Cholet

Cholet, France

Centre Hospitalier de Versailles André Mignot

Le Chesnay, France

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

Montfermeil, France

Hôpital Bichat - Claude-Bernard

Paris, France

CHU Bordeaux Haut-Leveque

Pessac, France

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, France

Hôpital Foch

Suresnes, France

KPPK Studienzentrum

Bendorf, Germany

Studienpraxis Berlin-Brandenburg Lennart Schaper

Berlin, Germany

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen

Essen, Germany

IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T

Frankfurt, Germany

ME Clinical Respiratory Research Hamburg

Hamburg, Germany

POIS Sachsen

Leipzig, Germany

IKF Pneumologie Mainz

Mainz, Germany

Dedicated Research Site FutureMeds

Offenbach, Germany

Galaxy Superspeciality Hospital

Aurangabad, India

Mahatma Gandhi Mission Medical College

Aurangabad, India

Medstar Speciality Hospital

Bangalore, India

All India Institute of Medical Sciences

Bhubaneswar, India

Aakash Healthcare Private Limited

Dwārka, India

Atmaram Child Care

Kanpur, India

All India Institute of Medical Sciences

New Delhi, India

Lifepoint Multispeciality Hospital

Pune, India

All India Institute of Medical Sciences

Raipur, India

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

Rohtak, India

Tokyo-Eki Center-building Clinic

Chūōku, Japan

Osaka Habikino Medical Center

Habikino, Japan

Aso Iizuka Hospital

Iizuka, Japan

Kagoshima University Hospital

Kagoshima, Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Japan

Kameari Internal Medicine and Respiratory Clinic

Katsushika-ku, Japan

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, Japan

International University of Health and Welfare Narita Hospital

Narita, Japan

Okayama University Hospital

Okayama, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Japan

San Peregrino Unidad de Investigación

Aguascalientes, Mexico

Scientia Investigacion Clinica S.C.

Chihuahua City, Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, Mexico

Instituto Jalisciense de Investigación Clínica Sa de Cv

Guadalajara, Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Mexico

Centro de Desarrollo Biomedico

Mérida, Mexico

Kohler & Milstein Research S.A. De C.V.

Mérida, Mexico

Cicmex Centro de Investigación Clínica de México

Morelia, Mexico

Centro de Investigacion Clinica Chapultepec

Querétaro, Mexico

FAICIC S. de R.L. de C.V.

Veracruz, Mexico

EB Medical Research

Almere Stad, Netherlands

Amphia Ziekenhuis, locatie Breda Molengracht

Breda, Netherlands

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Franciscus Gasthuis & Vlietland, Locatie Gasthuis

Rotterdam, Netherlands

Gelre Ziekenhuizen

Zutphen, Netherlands

Isala, locatie Zwolle

Zwolle, Netherlands

Centrum Medyczne ,,All - Med'' Badania Kliniczne

Krakow, Poland

Diamond Clinic

Krakow, Poland

Alergologia Plus sp. z o.o.

Poznan, Poland

Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o

Poznan, Poland

View Full Details on ClinicalTrials.gov

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NCT07219173

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