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.

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.

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement. URL: https://vivli.org/