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

Lilly

Status and phase: Not yet enrolling; Phase 2

Conditions: Asthma

Treatments: Drug: Brenipatide; Drug: Brenipatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07219173

2025-522640-41 (EudraCT Number)

27744

J2S-MC-GZMR (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 531 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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531 participants in 3 patient groups, including a placebo group

Brenipatide Dose 1

Experimental group

Description:

Brenipatide administered subcutaneously (SC)

Treatment:

Drug: Brenipatide

Drug: Brenipatide

Brenipatide Dose 2

Experimental group

Description:

Brenipatide administered SC.

Treatment:

Drug: Brenipatide

Drug: Brenipatide

Placebo

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo