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A Study of Brenipatide for Moderate to Severe Asthma

This study is testing a new medication called brenipatide for adults with moderate to severe asthma that is not well-controlled. Researchers want to see if brenipatide is safe and effective compared to a placebo (an inactive substance). You might be able to join if you are between 18 and 75 years old, have been diagnosed with asthma by a doctor, and have been taking asthma controller medication for at least 12 months. The main goal is to see how brenipatide affects the number of asthma attacks (exacerbations) over 52 weeks. The study is currently recruiting about 531 participants, but its exact status is unclear.

Study design
This is an interventional study comparing brenipatide to a placebo. It plans to enroll 531 adult participants.
What's involved
Your participation in the study will last about 65 weeks, including screening, treatment, and follow-up periods.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 52 weeks of treatment to measure the rate of asthma exacerbations.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07219173

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Eli Lilly and Company
~531 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BrenipatidePlacebo

At a glance

Recruiting sites
104 of 121 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
Measured over Baseline to Week 52

Conditions

Asthma

Explore related trials

Asthma

Where it's being run

121 sites across 22 states
China13
Japan12
Argentina10
Brazil10
Canada10
France10
India10
Mexico10

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-45 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Annualized Asthma Exacerbation Rate Over 52 Weeks of TreatmentBaseline to Week 52

    To assess the asthma exacerbation rate.