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

RecruitingPhase 2Ages 18 Years - 75 YearsAllEli Lilly and Company
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ1.5 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.
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What it tests

  • Brenipatide
  • Brenipatide
  • Placebo
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Where

119 sites
AMR Clinical
Tempe, United States
NewportNativeMD, Inc.
Newport Beach, United States
California Medical Research Associates
Northridge, United States
Peninsula Research Associates
Rolling Hills Estates, United States
Asthma & Allergy Associates - Colorado Springs
Colorado Springs, United States
AMR Clinical
Doral, United States
Renstar Medical Research
Ocala, United States
Avanza Medical Research Center
Pensacola, United States

โ€ฆand 111 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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