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NCT07219173PHASE2Recruiting

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

Eli Lilly and Company

Start Date

10/22/2025

Completion Date

6/1/2028

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 Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Brenipatide

DRUG

Brenipatide

DRUG

Placebo

Interested in This Trial?

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Conditions

Asthma

Locations

AMR Clinical

Tempe, Arizona 85281

United States

NewportNativeMD, Inc.

Newport Beach, California 92663

United States

California Medical Research Associates

Northridge, California 91324

United States

Peninsula Research Associates

Rolling Hills Estates, California 90274

United States

Asthma & Allergy Associates - Colorado Springs

Colorado Springs, Colorado 80907

United States

AMR Clinical

Doral, Florida 33172-2514

United States

Renstar Medical Research

Ocala, Florida 34470

United States

Avanza Medical Research Center

Pensacola, Florida 32503

United States

USF Health

Tampa, Florida 33613

United States

Axis Clinical Trials - Westchester

Westchester, Illinois 60154

United States

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky 42301

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

AMR Clinical

Las Vegas, Nevada 89119

United States

Equity Medical

New York, New York 10455

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania 15241

United States

Vanderbilt Asthma, Sinus and Allergy Program

Nashville, Tennessee 37203

United States

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

Buenos Aires, 1425

Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI

Argentina

Fundación Respirar

Buenos Aires, C1426ABP

Argentina

IDIM - Instituto de Investigaciones Metabólicas

Ciudad de Buenos Aires, C1012AAR

Argentina

Instituto de Asma, Alergia y Enfermedades Respiratorias

Corrientes, 3400

Argentina

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, 2152

Argentina

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, B7600FZO

Argentina

Instituto Médico Río Cuarto

Río Cuarto, X5800AEV

Argentina

ABC Instituto de Diagnóstico

Rosario, 2000

Argentina

Ibamedica

Santa Fe, 3000

Argentina

NewData Clinical Research - Aracaju

Aracaju, 49075-000

Brazil

Private Practice - Dr. Nelson Rosário

Curitiba, 80810-100

Brazil

Clinica de Pneumologia

Goiânia, 74110 030

Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, 17504-072

Brazil

Hospital Universitário Onofre Lopes

Natal, 59012-300

Brazil

Instituto Atena de Pesquisa Clinica

Natal, 59020-500

Brazil

Instituto Méderi de Pesquisa e Saúde

Passo Fundo, 99010-120

Brazil

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, 14051-140

Brazil

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, 20241-180

Brazil

Clinica de Alergia Martti Antila

Sorocaba, 18040-425

Brazil

Dynamic Drug Advancement

Ajax, L1S 2J5

Canada

Heritage Medical Research Clinic

Calgary, T2N 4Z6

Canada

St. Joseph's Healthcare Hamilton

Hamilton, L8N 4A6

Canada

Kelowna Health and Memory Centre

Kelowna, V1Y 5A8

Canada

McGill University Health Centre

Montreal, H4A 3J1

Canada

IUCPQ

Québec, G1V 4G5

Canada

Richmond Clinical Trials

Richmond, V6V 2L1

Canada

C.I.C. Saint-Laurent

Saint-Laurent, H4R 3C8

Canada

Inspiration Research

Toronto, M5T 3A9

Canada

Dr. Syed Anees Medicine Professional Corporation

Windsor, N8X 1T3

Canada

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

Baotou, 014010

China

Beijing Chaoyang Hospital, Capital Medical University

Beijing, 100020

China

West China Hospital, Sichuan University

Chengdu, 610041

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016

China

Zhejiang Provincial People's Hospital

Hangzhou, 310014

China

Jiangxi Provincial People's Hospital

Nanchang, 330006

China

Nanjing Medical University - Nanjing Jiangning Hospital

Nanjing, 211103

China

Shanghai General Hospital

Shanghai, 200080

China

The University of Hong Kong-Shenzhen Hospital

Shenzhen, 518053

China

The Second Afilliated Hospital of Hebei Medical University

Shijiazhuang, 050000

China

Tianjin Medical University General Hospital

Tianjin, 300052

China

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

Wenzhou, 315100

China

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

Wuhan, 430030

China

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

Aix-en-Provence, 13100

France

CHRU de Brest

Brest, 29609

France

Centre Hospitalier de Cholet

Cholet, 49325

France

Centre Hospitalier de Versailles André Mignot

Le Chesnay, 78157

France

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270

France

Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

Montfermeil, 93370

France

Hôpital Bichat - Claude-Bernard

Paris, 75018

France

CHU Bordeaux Haut-Leveque

Pessac, 33600

France

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, 35033

France

Hôpital Foch

Suresnes, 92150

France

KPPK Studienzentrum

Bendorf, 56170

Germany

Studienpraxis Berlin-Brandenburg Lennart Schaper

Berlin, 10119

Germany

Ambulantes Lungenzentrum Essen

Essen, 45127

Germany

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen

Essen, 45239

Germany

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

Frankfurt, 60596

Germany

ME Clinical Respiratory Research Hamburg

Hamburg, 22299

Germany

POIS Sachsen

Leipzig, 04347

Germany

IKF Pneumologie Mainz

Mainz, 55128

Germany

Dedicated Research Site FutureMeds

Offenbach, 63065

Germany

Galaxy Superspeciality Hospital

Aurangabad, 431001

India

Mahatma Gandhi Mission Medical College

Aurangabad, 431003

India

Medstar Speciality Hospital

Bangalore, 560092

India

All India Institute of Medical Sciences

Bhubaneswar, 751019

India

Aakash Healthcare Private Limited

Dwārka, 110075

India

Atmaram Child Care

Kanpur, 208011

India

All India Institute of Medical Sciences

New Delhi, 110029

India

Lifepoint Multispeciality Hospital

Pune, 411057

India

All India Institute of Medical Sciences

Raipur, 492099

India

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

Rohtak, 124001

India

Tokyo-Eki Center-building Clinic

Chūōku, 103-0027

Japan

Osaka Habikino Medical Center

Habikino, 583-8588

Japan

Aso Iizuka Hospital

Iizuka, 820-8505

Japan

Kagoshima University Hospital

Kagoshima, 890-8520

Japan

Ishikawa Prefectural Central Hospital

Kanazawa, 920-8530

Japan

Kameari Internal Medicine and Respiratory Clinic

Katsushika-ku, 125-0061

Japan

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, 457-8510

Japan

International University of Health and Welfare Narita Hospital

Narita, 286-8520

Japan

Okayama University Hospital

Okayama, 700-8558

Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192

Japan

Osaka Metropolitan University Hospital

Osaka, 545-8586

Japan

Kanagawa Cardiovascular and Respiratory Center

Yokohama, 236-0051

Japan

San Peregrino Unidad de Investigación

Aguascalientes, 20230

Mexico

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207

Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, 34000

Mexico

Instituto Jalisciense de Investigación Clínica Sa de Cv

Guadalajara, 44100

Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, 44650

Mexico

Centro de Desarrollo Biomedico

Mérida, 97000

Mexico

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

Mérida, 97070

Mexico

Cicmex Centro de Investigación Clínica de México

Morelia, 58020

Mexico

Centro de Investigacion Clinica Chapultepec

Querétaro, 76088

Mexico

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

Veracruz, 91900

Mexico

EB Medical Research

Almere Stad, 1311 RL

Netherlands

Amphia Ziekenhuis, locatie Breda Molengracht

Breda, 4818 CK

Netherlands

Canisius-Wilhelmina Ziekenhuis

Nijmegen, 6532 SZ

Netherlands

Franciscus Gasthuis & Vlietland, Locatie Gasthuis

Rotterdam, 3045 PM

Netherlands

Gelre Ziekenhuizen

Zutphen, 7207 AE

Netherlands

Isala, locatie Zwolle

Zwolle, 8025 AB

Netherlands

Centrum Medyczne ,,All - Med'' Badania Kliniczne

Krakow, 30-033

Poland

Diamond Clinic

Krakow, 31-559

Poland

Alergologia Plus sp. z o.o.

Poznan, 60-693

Poland

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

Poznan, 61-578

Poland