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

NCT07219173

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Asthma

Interventions: Brenipatide, Brenipatide, Placebo

Countries: United States, Argentina, Brazil, Canada, China, France, Germany, India

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (121)
  • Tempe, Arizona, United States
  • Newport Beach, California, United States
  • Northridge, California, United States
  • Rolling Hills Estates, California, United States
  • Colorado Springs, Colorado, United States
  • Doral, Florida, United States
  • Ocala, Florida, United States
  • Pensacola, Florida, United States
  • Tampa, Florida, United States
  • Westchester, Illinois, United States
  • Owensboro, Kentucky, United States
  • Boston, Massachusetts, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • Pittsburgh, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Corrientes, Argentina
  • Granadero Baigorria, Argentina
  • Mar del Plata, Argentina
  • Río Cuarto, Argentina
  • Rosario, Argentina
  • Santa Fe, Argentina
  • Aracaju, Brazil
  • Curitiba, Brazil
  • Goiânia, Brazil
  • + 91 more on CT.gov