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Phase 2 Study Evaluates Brenipatide for Moderate-to-Severe AsthmaCould a new drug help people with severe asthma breathe easier?

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Key Takeaway
Evaluate brenipatide's impact on asthma exacerbation rates over 52 weeks.

This Phase 2 study, sponsored by Eli Lilly and Company, is currently recruiting participants to evaluate the safety and efficacy of brenipatide in adults with uncontrolled moderate-to-severe asthma. The trial will compare different dose levels of brenipatide against a placebo. A total of 531 participants are estimated to enroll, with the study spanning approximately 65 weeks, including screening, treatment, and follow-up periods. The primary outcome measure is the annualized asthma exacerbation rate over 52 weeks of treatment. The study began on October 22, 2025, with a primary completion date set for April 2028. This trial aims to provide insights into the potential benefits of brenipatide for asthma management.

Living with moderate to severe asthma can be challenging, with frequent flare-ups making it hard to breathe and enjoy life. A new study is evaluating a drug called brenipatide to see if it can help adults with this condition. The study will last about 65 weeks and will compare different doses of brenipatide to a placebo, which is a treatment that doesn’t contain an active drug. The main goal is to measure how often asthma flare-ups occur over a year of treatment. With an estimated 531 participants, this research could provide valuable insights into a new option for those struggling to control their asthma. If brenipatide proves effective, it might lead to better control of symptoms and improved quality of life for many people.

What this means for you:
Brenipatide is being tested to see if it can reduce asthma flare-ups in adults with severe asthma.

Study Details

Study typePhase2
Sample sizen = 531
EvidenceLevel 3
Follow-up29.3 mo
PublishedMar 2026
View Original Abstract ↓
Status: RECRUITING | Phase: PHASE2 Condition(s): Asthma Intervention(s): Brenipatide (DRUG), Brenipatide (DRUG), Placebo (DRUG) 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. Primary Outcome(s): Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment Enrollment: 531 (ESTIMATED) Lead Sponsor: Eli Lilly and Company Start: 2025-10-22 | Primary Completion: 2028-04
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