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

A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma

Phase 2 Interventional Eli Lilly and Company · NCT07219173

This trial tests whether different doses of brenipatide can safely improve asthma control and reduce severe attacks in adults with uncontrolled moderate-to-severe asthma.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment531 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations121 sites (Tempe, Arizona and 120 other locations)
Trial IDNCT07219173 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with physician-diagnosed asthma who have used a prescribed asthma controller for at least 12 months, have an ACQ-6 score ≥1.5 on two of three visits, and had at least one severe exacerbation requiring systemic steroids in the past year.

Not a fit: Patients with occupational asthma, other significant chronic lung diseases (for example COPD, bronchiectasis, pulmonary fibrosis), or those whose asthma is well controlled are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, brenipatide could improve symptom control and reduce the frequency or severity of exacerbations for adults with uncontrolled moderate-to-severe asthma.

How similar studies have performed: Early preclinical work and small clinical observations of incretin-related therapies hint at potential anti-inflammatory effects in airways, but large randomized data in asthma are limited.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Tempe, Arizona and 120 other locations

+71 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaIncretin
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.