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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT07219173

Run by

Eli Lilly and Company

People needed

531

Starts

2025-10-22

Expected to finish

2028-06-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• AMR Clinical — Tempe, Arizona, United States (enrolling)
• California Medical Research Associates — Northridge, California, United States (enrolling)
• NewportNativeMD, Inc. — Newport Beach, California, United States (enrolling)
• Asthma & Allergy Associates - Colorado Springs — Colorado Springs, Colorado, United States (enrolling)
• AMR Clinical — Doral, Florida, United States (enrolling)
• Renstar Medical Research — Ocala, Florida, United States (enrolling)
• Peninsula Research Associates — Rolling Hills Estates, California, United States (enrolling)
• USF Health — Tampa, Florida, United States (enrolling)
• Axis Clinical Trials - Westchester — Westchester, Illinois, United States (enrolling)
• Allergy & Asthma Specialists, P.S.C. — Owensboro, Kentucky, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• AMR Clinical — Las Vegas, Nevada, United States (enrolling)
• Equity Medical — New York, New York, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States (enrolling)
• Avanza Medical Research Center — Pensacola, Florida, United States (enrolling)
• Consultorios Médicos, Organización del Buen Ayre S.R.L. — Buenos Aires, Argentina (enrolling)
• Centro de Investigaciones Metabólicas (CINME) — Buenos Aires, Argentina (enrolling)
• Fundación Respirar — Buenos Aires, Argentina (enrolling)
• IDIM - Instituto de Investigaciones Metabólicas — Ciudad de Buenos Aires, Argentina (enrolling)
• Instituto de Asma, Alergia y Enfermedades Respiratorias — Corrientes, Argentina (enrolling)
• Centro de Investigaciones Clínicas Baigorria — Granadero Baigorria, Argentina (enrolling)
• Instituto de Investigaciones Clínicas Mar del Plata — Mar del Plata, Argentina (enrolling)
• Instituto Médico Río Cuarto — Río Cuarto, Argentina (enrolling)
• ABC Instituto de Diagnóstico — Rosario, Argentina (enrolling)

Full record on ClinicalTrials.gov

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