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

RecruitingPhase 2

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

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 531 · Started: Oct 22, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07219173

Locations in the U.S.

ArizonaAMR Clinical, Tempe
CaliforniaNewportNativeMD, Inc., Newport Beach
California Medical Research Associates, Northridge
Peninsula Research Associates, Rolling Hills Estates
ColoradoAsthma & Allergy Associates - Colorado Springs, Colorado Springs
FloridaAMR Clinical, Doral
Renstar Medical Research, Ocala
Avanza Medical Research Center, Pensacola
USF Health, Tampa
IllinoisAxis Clinical Trials - Westchester, Westchester
KentuckyAllergy & Asthma Specialists, P.S.C., Owensboro
MassachusettsBrigham and Women's Hospital, Boston
NevadaAMR Clinical, Las Vegas
New YorkEquity Medical, New York
PennsylvaniaAllergy and Clinical Immunology Associates, Pittsburgh
University of Pittsburgh Medical Center, Pittsburgh
TennesseeVanderbilt Asthma, Sinus and Allergy Program, Nashville (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.