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

Purpose

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.

Condition

  • Asthma

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brenipatide Dose 1 		Brenipatide administered subcutaneously (SC)
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
Experimental
Brenipatide Dose 2 		Brenipatide administered SC.
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
Placebo Comparator
Placebo 		Placebo administered SC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
317-615-4559
LillyTrials@Lilly.com