Brenipatide versus placebo for adults with uncontrolled moderate-to-severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, placebo-controlled interventional trial comparing multiple dose levels of brenipatide with placebo over a treatment period within an overall participation time of about 65 weeks including screening and follow-up. Adult participants who have been on controller medication for at least 12 months, have an ACQ-6 score ≥1.5 on 2 of 3 pre-randomization visits, and a history of at least one severe exacerbation in the prior year are eligible. Participants will be assigned to receive brenipatide at specified dose levels or matching placebo and monitored for safety, changes in asthma control (e.g., ACQ-6), and exacerbation frequency. Key exclusions include occupational asthma and other clinically important chronic lung diseases that could mimic or complicate asthma.

Why it matters

Who can join: the full rules

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.

Where it's running

• AMR Clinical
  Tempe, Arizona, United States Recruiting
• NewportNativeMD, Inc.
  Newport Beach, California, United States Recruiting
• California Medical Research Associates
  Northridge, California, United States Recruiting
• Peninsula Research Associates
  Rolling Hills Estates, California, United States Recruiting
• Asthma & Allergy Associates - Colorado Springs
  Colorado Springs, Colorado, United States Recruiting
• AMR Clinical
  Doral, Florida, United States Recruiting

+70 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.