Recruiting

Phase 2

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

Sponsor:

Eli Lilly and Company

Code:

NCT07219173

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Brenipatide

Placebo

Study Details

Brief 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.

Conditions

Asthma

Study ID

NCT07219173

Start date

Oct 22, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

531 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brenipatide Dose 1

Brenipatide administered subcutaneously (SC)

experimental: Brenipatide Dose 2

Brenipatide administered SC.

placebo comparator: Placebo

Placebo administered SC.

Interventions

Brenipatide

Administered SC

Brenipatide

Administered SC

Placebo

Administered SC

Primary outcome measure

Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment [ Time Frame: Baseline to Week 52 ]

Central Contacts and Locations

Central contacts

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

317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

AMR Clinical

Recruiting

Tempe, Arizona, United States, 85281

Contacts

602-910-3343

Principal Investigator:

William Reedy

NewportNativeMD, Inc.

Recruiting

Newport Beach, California, United States, 92663

Contacts

949-791-8599

Principal Investigator:

Ryan Klein

California Medical Research Associates

Recruiting

Northridge, California, United States, 91324

Principal Investigator:

Sanjay Vadgama

Peninsula Research Associates

Recruiting

Rolling Hills Estates, California, United States, 90274

Contacts

310-265-1623

Principal Investigator:

Lawrence Sher

Asthma & Allergy Associates - Colorado Springs

Recruiting

Colorado Springs, Colorado, United States, 80907

Principal Investigator:

Luke Webb

AMR Clinical

Recruiting

Doral, Florida, United States, 33172-2514

Principal Investigator:

Abid Chaudhry

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34470

Contacts

352-629-5800

Principal Investigator:

Raj Karunakara

Avanza Medical Research Center

Recruiting

Pensacola, Florida, United States, 32503

Contacts

850-477-7900

Principal Investigator:

Linda McCafferty

USF Health

Recruiting

Tampa, Florida, United States, 33613

Contacts

813-631-4024

Principal Investigator:

Thomas Casale

Axis Clinical Trials - Westchester

Recruiting

Westchester, Illinois, United States, 60154

Principal Investigator:

Mohammad Ghani

Allergy & Asthma Specialists, P.S.C.

Recruiting

Owensboro, Kentucky, United States, 42301

Contacts

270-684-6144

Principal Investigator:

Lee Clore

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Dinah Foer

AMR Clinical

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

702-597-9825

Principal Investigator:

Michael Jacobs

Equity Medical

Recruiting

New York, New York, United States, 10455

Contacts

908-303-9909

Principal Investigator:

Alissa McInerney

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

630-981-1261

Principal Investigator:

Marc Gauthier

Allergy and Clinical Immunology Associates

Recruiting

Pittsburgh, Pennsylvania, United States, 15241

Contacts

412-833-4051

Principal Investigator:

Michael Palumbo

Dynamic Drug Advancement

Recruiting

Ajax, Canada, L1S 2J5

Contacts

3658859086

Principal Investigator:

George Philteos

Kelowna Health and Memory Centre

Recruiting

Kelowna, Canada, V1Y 5A8

Principal Investigator:

Colleen Maytham

Richmond Clinical Trials

Recruiting

Richmond, Canada, V6V 2L1

Contacts

604-373-4954

Principal Investigator:

Alexandra Lucas

C.I.C. Saint-Laurent

Recruiting

Saint-Laurent, Canada, H4R 3C8

Principal Investigator:

Isabel Coman

Dr. Syed Anees Medicine Professional Corporation

Recruiting

Windsor, Canada, N8X 1T3

Contacts

(519) 252-4448

Principal Investigator:

Syed Anees

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

Incretin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-21.