Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07219173

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

Led by Eli Lilly and Company · Updated on 2026-05-14

531

Participants Needed

122

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Physician-diagnosed asthma with at least 12 months of prescribed asthma controller medication prior to screening
  • Asthma control questionnaire-6 (ACQ-6) score of 1.5 or higher on at least 2 of 3 visits before randomization
  • At least 1 severe asthma exacerbation requiring systemic glucocorticoid treatment in the 12 months before screening
Not Eligible

You will not qualify if you...

  • Diagnosis of occupational asthma
  • Known significant lung conditions other than asthma, such as chronic respiratory infection, bronchiectasis, pulmonary fibrosis, allergic bronchopulmonary aspergillosis, emphysema, chronic bronchitis, eosinophilic granulomatosis with polyangiitis, chronic obstructive pulmonary disease, or vocal cord dysfunction
  • Current or recent acute active infection within 30 days before screening and up to randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 122 locations

1

AMR Clinical

Tempe, Arizona, United States, 85281

Actively Recruiting

2

NewportNativeMD, Inc.

Newport Beach, California, United States, 92663

Actively Recruiting

3

California Medical Research Associates

Northridge, California, United States, 91324

Actively Recruiting

4

Peninsula Research Associates

Rolling Hills Estates, California, United States, 90274

Actively Recruiting

5

Asthma & Allergy Associates - Colorado Springs

Colorado Springs, Colorado, United States, 80907

Actively Recruiting

6

AMR Clinical

Doral, Florida, United States, 33172-2514

Actively Recruiting

7

Renstar Medical Research

Ocala, Florida, United States, 34470

Actively Recruiting

8

Avanza Medical Research Center

Pensacola, Florida, United States, 32503

Actively Recruiting

9

USF Health

Tampa, Florida, United States, 33613

Actively Recruiting

10

Axis Clinical Trials - Westchester

Westchester, Illinois, United States, 60154

Actively Recruiting

11

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, United States, 42301

Actively Recruiting

12

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

13

AMR Clinical

Las Vegas, Nevada, United States, 89119

Actively Recruiting

14

Equity Medical

New York, New York, United States, 10455

Actively Recruiting

15

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Not Yet Recruiting

16

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States, 15241

Actively Recruiting

17

Vanderbilt Asthma, Sinus and Allergy Program

Nashville, Tennessee, United States, 37203

Not Yet Recruiting

18

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

Buenos Aires, Argentina, 1425

Not Yet Recruiting

19

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina, C1056ABI

Not Yet Recruiting

20

Fundación Respirar

Buenos Aires, Argentina, C1426ABP

Not Yet Recruiting

21

IDIM - Instituto de Investigaciones Metabólicas

Ciudad de Buenos Aires, Argentina, C1012AAR

Not Yet Recruiting

22

Instituto de Asma, Alergia y Enfermedades Respiratorias

Corrientes, Argentina, 3400

Not Yet Recruiting

23

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Argentina, 2152

Not Yet Recruiting

24

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Argentina, B7600FZO

Not Yet Recruiting

25

Instituto Médico Río Cuarto

Río Cuarto, Argentina, X5800AEV

Not Yet Recruiting

26

ABC Instituto de Diagnóstico

Rosario, Argentina, 2000

Not Yet Recruiting

27

Ibamedica

Santa Fe, Argentina, 3000

Not Yet Recruiting

28

NewData Clinical Research - Aracaju

Aracaju, Brazil, 49075-000

Not Yet Recruiting

29

Private Practice - Dr. Nelson Rosário

Curitiba, Brazil, 80810-100

Not Yet Recruiting

30

Clinica de Pneumologia

Goiânia, Brazil, 74110 030

Not Yet Recruiting

31

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, Brazil, 17504-072

Not Yet Recruiting

32

Hospital Universitário Onofre Lopes

Natal, Brazil, 59012-300

Not Yet Recruiting

33

Instituto Atena de Pesquisa Clinica

Natal, Brazil, 59020-500

Not Yet Recruiting

34

Instituto Méderi de Pesquisa e Saúde

Passo Fundo, Brazil, 99010-120

Actively Recruiting

35

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, Brazil, 14051-140

Not Yet Recruiting

36

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, Brazil, 20241-180

Not Yet Recruiting

37

Clinica de Alergia Martti Antila

Sorocaba, Brazil, 18040-425

Actively Recruiting

38

Dynamic Drug Advancement

Ajax, Canada, L1S 2J5

Actively Recruiting

39

Heritage Medical Research Clinic

Calgary, Canada, T2N 4Z6

Not Yet Recruiting

40

University Of Alberta Hospital

Edmonton, Canada, T6G 1W9

Suspended

41

St. Joseph's Healthcare Hamilton

Hamilton, Canada, L8N 4A6

Not Yet Recruiting

42

Kelowna Health and Memory Centre

Kelowna, Canada, V1Y 5A8

Actively Recruiting

43

McGill University Health Centre

Montreal, Canada, H4A 3J1

Not Yet Recruiting

44

IUCPQ

Québec, Canada, G1V 4G5

Not Yet Recruiting

45

Richmond Clinical Trials

Richmond, Canada, V6V 2L1

Actively Recruiting

46

C.I.C. Saint-Laurent

Saint-Laurent, Canada, H4R 3C8

Actively Recruiting

47

Inspiration Research

Toronto, Canada, M5T 3A9

Not Yet Recruiting

48

Dr. Syed Anees Medicine Professional Corporation

Windsor, Canada, N8X 1T3

Actively Recruiting

49

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

Baotou, China, 014010

Actively Recruiting

50

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China, 100020

Actively Recruiting

51

West China Hospital, Sichuan University

Chengdu, China, 610041

Actively Recruiting

52

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China, 400016

Actively Recruiting

53

Zhejiang Provincial People's Hospital

Hangzhou, China, 310014

Actively Recruiting

54

Jiangxi Provincial People's Hospital

Nanchang, China, 330006

Actively Recruiting

55

Nanjing Medical University - Nanjing Jiangning Hospital

Nanjing, China, 211103

Actively Recruiting

56

Shanghai General Hospital

Shanghai, China, 200080

Actively Recruiting

57

The University of Hong Kong-Shenzhen Hospital

Shenzhen, China, 518053

Actively Recruiting

58

The Second Afilliated Hospital of Hebei Medical University

Shijiazhuang, China, 050000

Actively Recruiting

59

Tianjin Medical University General Hospital

Tianjin, China, 300052

Actively Recruiting

60

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

Wenzhou, China, 315100

Actively Recruiting

61

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

Wuhan, China, 430030

Actively Recruiting

62

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

Aix-en-Provence, France, 13100

Actively Recruiting

63

CHRU de Brest

Brest, France, 29609

Actively Recruiting

64

Centre Hospitalier de Cholet

Cholet, France, 49325

Actively Recruiting

65

Centre Hospitalier de Versailles André Mignot

Le Chesnay, France, 78157

Not Yet Recruiting

66

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, France, 94270

Actively Recruiting

67

Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

Montfermeil, France, 93370

Not Yet Recruiting

68

Hôpital Bichat - Claude-Bernard

Paris, France, 75018

Actively Recruiting

69

CHU Bordeaux Haut-Leveque

Pessac, France, 33600

Not Yet Recruiting

70

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, France, 35033

Not Yet Recruiting

71

Hôpital Foch

Suresnes, France, 92150

Actively Recruiting

72

KPPK Studienzentrum

Bendorf, Germany, 56170

Actively Recruiting

73

Studienpraxis Berlin-Brandenburg Lennart Schaper

Berlin, Germany, 10119

Actively Recruiting

74

Ambulantes Lungenzentrum Essen

Essen, Germany, 45127

Not Yet Recruiting

75

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen

Essen, Germany, 45239

Actively Recruiting

76

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

Frankfurt, Germany, 60596

Actively Recruiting

77

ME Clinical Respiratory Research Hamburg

Hamburg, Germany, 22299

Actively Recruiting

78

POIS Sachsen

Leipzig, Germany, 04347

Actively Recruiting

79

IKF Pneumologie Mainz

Mainz, Germany, 55128

Actively Recruiting

80

Dedicated Research Site FutureMeds

Offenbach, Germany, 63065

Actively Recruiting

81

Galaxy Superspeciality Hospital

Aurangabad, India, 431001

Not Yet Recruiting

82

Mahatma Gandhi Mission Medical College

Aurangabad, India, 431003

Not Yet Recruiting

83

Medstar Speciality Hospital

Bangalore, India, 560092

Not Yet Recruiting

84

All India Institute of Medical Sciences

Bhubaneswar, India, 751019

Not Yet Recruiting

85

Aakash Healthcare Private Limited

Dwārka, India, 110075

Not Yet Recruiting

86

Atmaram Child Care

Kanpur, India, 208011

Not Yet Recruiting

87

All India Institute of Medical Sciences

New Delhi, India, 110029

Not Yet Recruiting

88

Lifepoint Multispeciality Hospital

Pune, India, 411057

Not Yet Recruiting

89

All India Institute of Medical Sciences

Raipur, India, 492099

Not Yet Recruiting

90

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

Rohtak, India, 124001

Not Yet Recruiting

91

Tokyo-Eki Center-building Clinic

Chūōku, Japan, 103-0027

Actively Recruiting

92

Osaka Habikino Medical Center

Habikino, Japan, 583-8588

Actively Recruiting

93

Aso Iizuka Hospital

Iizuka, Japan, 820-8505

Actively Recruiting

94

Kagoshima University Hospital

Kagoshima, Japan, 890-8520

Actively Recruiting

95

Ishikawa Prefectural Central Hospital

Kanazawa, Japan, 920-8530

Actively Recruiting

96

Kameari Internal Medicine and Respiratory Clinic

Katsushika-ku, Japan, 125-0061

Actively Recruiting

97

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, Japan, 457-8510

Actively Recruiting

98

International University of Health and Welfare Narita Hospital

Narita, Japan, 286-8520

Not Yet Recruiting

99

Okayama University Hospital

Okayama, Japan, 700-8558

Actively Recruiting

100

National Hospital Organization Okayama Medical Center

Okayama, Japan, 701-1192

Actively Recruiting

101

Osaka Metropolitan University Hospital

Osaka, Japan, 545-8586

Actively Recruiting

102

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Japan, 236-0051

Actively Recruiting

103

San Peregrino Unidad de Investigación

Aguascalientes, Mexico, 20230

Not Yet Recruiting

104

Scientia Investigacion Clinica S.C.

Chihuahua City, Mexico, 31207

Not Yet Recruiting

105

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, Mexico, 34000

Not Yet Recruiting

106

Instituto Jalisciense de Investigación Clínica Sa de Cv

Guadalajara, Mexico, 44100

Not Yet Recruiting

107

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Mexico, 44650

Not Yet Recruiting

108

Centro de Desarrollo Biomedico

Mérida, Mexico, 97000

Not Yet Recruiting

109

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

Mérida, Mexico, 97070

Not Yet Recruiting

110

Cicmex Centro de Investigación Clínica de México

Morelia, Mexico, 58020

Not Yet Recruiting

111

Centro de Investigacion Clinica Chapultepec

Querétaro, Mexico, 76088

Not Yet Recruiting

112

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

Veracruz, Mexico, 91900

Not Yet Recruiting

113

EB Medical Research

Almere Stad, Netherlands, 1311 RL

Not Yet Recruiting

114

Amphia Ziekenhuis, locatie Breda Molengracht

Breda, Netherlands, 4818 CK

Not Yet Recruiting

115

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Netherlands, 6532 SZ

Not Yet Recruiting

116

Franciscus Gasthuis & Vlietland, Locatie Gasthuis

Rotterdam, Netherlands, 3045 PM

Not Yet Recruiting

117

Gelre Ziekenhuizen

Zutphen, Netherlands, 7207 AE

Not Yet Recruiting

118

Isala, locatie Zwolle

Zwolle, Netherlands, 8025 AB

Not Yet Recruiting

119

Centrum Medyczne ,,All - Med'' Badania Kliniczne

Krakow, Poland, 30-033

Actively Recruiting

120

Diamond Clinic

Krakow, Poland, 31-559

Actively Recruiting

121

Alergologia Plus sp. z o.o.

Poznan, Poland, 60-693

Actively Recruiting

122

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

Poznan, Poland, 61-578

Actively Recruiting

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Research Team

T

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

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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