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

Not Applicable

Recruiting

• Conditions: Asthma
• Interventions: Drug: Brenipatide; Drug: Placebo

• Registration Number: NCT07219173
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-10-20
• Study First Submitted QC: 2025-10-20
• Study First Posted: 2025-10-21
• Study Start: 2025-10-22
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-03
• Last Update Posted: 2025-11-04
• Primary Completion: 2028-04
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 531

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brenipatide Dose 1	Brenipatide	Brenipatide administered subcutaneously (SC)
Brenipatide Dose 2	Brenipatide	Brenipatide administered SC.
Placebo	Placebo	Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment	Baseline to Week 52	To assess the asthma exacerbation rate.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)	Baseline, Week 52
Change from Baseline in Patient Reported Health Outcomes	Baseline, Week 52
Time to First Exacerbation	Baseline to Week 52
Change from Baseline in Weekly Mean Rescue Medication Use	Baseline, Week 52
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide	Baseline up to Week 52
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)	Baseline to Week 52

Trial Locations

Locations (113)

Osaka Metropolitan University Hospital; 🇯🇵 Osaka, Japan

Kanagawa Cardiovascular and Respiratory Center; 🇯🇵 Yokohama, Japan

AMR Clinical; 🇺🇸 Las Vegas, Nevada, United States

NewportNativeMD, Inc.; 🇺🇸 Newport Beach, California, United States

California Medical Research Associates; 🇺🇸 Northridge, California, United States

Peninsula Research Associates; 🇺🇸 Rolling Hills Estates, California, United States

Asthma & Allergy Associates - Colorado Springs; 🇺🇸 Colorado Springs, Colorado, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Avanza Medical Research Center; 🇺🇸 Pensacola, Florida, United States

USF Health; 🇺🇸 Tampa, Florida, United States

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