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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

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

AMR Clinical
Tempe, Arizona 85281
Contact:
602-910-3343

NewportNativeMD, Inc.
Newport Beach, California 92663
Contact:
949-791-8599

California Medical Research Associates
Northridge, California 91324

Peninsula Research Associates
Rolling Hills Estates, California 90274
Contact:
310-265-1623

Asthma & Allergy Associates - Colorado Springs
Colorado Springs, Colorado 80907

AMR Clinical
Doral, Florida 33172-2514

Renstar Medical Research
Ocala, Florida 34470
Contact:
352-629-5800

Avanza Medical Research Center
Pensacola, Florida 32503
Contact:
850-477-7900

USF Health
Tampa, Florida 33613
Contact:
813-631-4024

Axis Clinical Trials - Westchester
Westchester, Illinois 60154

Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky 42301
Contact:
270-684-6144

Brigham and Women's Hospital
Boston, Massachusetts 02115

AMR Clinical
Las Vegas, Nevada 89119
Contact:
702-597-9825

Equity Medical
New York, New York 10455

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Contact:
630-981-1261

Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania 15241
Contact:
412-833-4051

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.