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

ConditionAsthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

An established diagnosis of occupational asthma

chronic respiratory infection

bronchiectasis

pulmonary fibrosis

Trial design

Treatments tested in this trial

  • Brenipatide
  • Brenipatide
  • Placebo

Treatment groups

531 Participants
are divided into 3 treatment groups

Locations

122
Argentina
Centro de Investigaciones Metabólicas (CINME)C1056ABI, Buenos Aires Argentina
Consultorios Médicos, Organización del Buen Ayre S.R.L.1425, Buenos Aires Argentina
Fundación RespirarC1426ABP, Buenos Aires Argentina
IDIM - Instituto de Investigaciones MetabólicasC1012AAR, Ciudad de Buenos Aires Argentina

Sponsors and collaborators

Eli Lilly and Company

Lead sponsor