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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• AMR Clinical, Tempe, Arizona, United States
• NewportNativeMD, Inc., Newport Beach, California, United States
• California Medical Research Associates, Northridge, California, United States
• Peninsula Research Associates, Rolling Hills Estates, California, United States
• Asthma & Allergy Associates - Colorado Springs, Colorado Springs, Colorado, United States
• AMR Clinical, Doral, Florida, United States
• Renstar Medical Research, Ocala, Florida, United States
• Avanza Medical Research Center, Pensacola, Florida, United States
• USF Health, Tampa, Florida, United States
• Axis Clinical Trials - Westchester, Westchester, Illinois, United States
• Allergy & Asthma Specialists, P.S.C., Owensboro, Kentucky, United States
• Brigham and Women's Hospital, Boston, Massachusetts, United States

+ 109 more sites.

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 317-615-4559 · LillyTrials@Lilly.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07219173.