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A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07219173•Eli Lilly and Company

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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

Key Dates

Start Date

October 22, 2025

Primary Completion Date

April 1, 2028

Completion Date

June 1, 2028

Last Updated

March 20, 2026

Enrollment

531

ESTIMATED participants

Conditions

Asthma

Interventions

Brenipatide

DRUG

Brenipatide

DRUG

Placebo

DRUG

Contacts

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

CONTACT

317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

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Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)