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

NCT07219173
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
531
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Lead sponsor
Eli Lilly and Company
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Start date
2025-10-22
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Number of sites
119
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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.
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Acronym
RENEW-Asthma
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Short title
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
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Official title
A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-06-01
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First posted
2025-10-21
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Registry last updated
2026-10-22
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Primary completion date
2028-04-01
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Start date
2025-10-22
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Participants
531
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Participant count basis
Estimated
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Planned participants
531
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Protocol amendments
1
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Number of sites
119
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07219173
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ClinicalTrials.gov ID
NCT07219173
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Care providers
Sources for study design
clinicaltrials.gov

  1. Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment

    Timeframe: Baseline to Week 52

    To assess the asthma exacerbation rate.

  1. Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)

    Timeframe: Baseline, Week 52

  2. Change from Baseline in Patient Reported Health Outcomes

    Timeframe: Baseline, Week 52

  3. Time to First Exacerbation

    Timeframe: Baseline to Week 52

  4. Change from Baseline in Weekly Mean Rescue Medication Use

    Timeframe: Baseline, Week 52

  5. Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

    Timeframe: Baseline up to Week 52

  6. Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)

    Timeframe: Baseline to Week 52

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.

  • 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.

Sources for eligibility
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  • AMR ClinicalTempe, United StatesRecruiting
  • NewportNativeMD, Inc.Newport Beach, United StatesRecruiting
  • California Medical Research AssociatesNorthridge, United StatesRecruiting
  • Peninsula Research AssociatesRolling Hills Estates, United StatesRecruiting
  • Asthma & Allergy Associates - Colorado SpringsColorado Springs, United StatesRecruiting
  • AMR ClinicalDoral, United StatesRecruiting
  • Renstar Medical ResearchOcala, United StatesRecruiting
  • Avanza Medical Research CenterPensacola, United StatesRecruiting
  • USF HealthTampa, United StatesRecruiting
  • Axis Clinical Trials - WestchesterWestchester, United StatesRecruiting
  • Allergy & Asthma Specialists, P.S.C.Owensboro, United StatesRecruiting
  • Brigham and Women's HospitalBoston, United StatesRecruiting
  • AMR ClinicalLas Vegas, United StatesRecruiting
  • Equity MedicalNew York, United StatesRecruiting
  • University of Pittsburgh Medical CenterPittsburgh, United StatesRecruiting
  • Allergy and Clinical Immunology AssociatesPittsburgh, United StatesRecruiting
  • Vanderbilt Asthma, Sinus and Allergy ProgramNashville, United StatesNot yet recruiting
  • Consultorios Médicos, Organización del Buen Ayre S.R.L.Buenos Aires, ArgentinaRecruiting
  • Centro de Investigaciones Metabólicas (CINME)Buenos Aires, ArgentinaRecruiting
  • Fundación RespirarBuenos Aires, ArgentinaRecruiting
  • IDIM - Instituto de Investigaciones MetabólicasCiudad de Buenos Aires, ArgentinaRecruiting
  • Instituto de Asma, Alergia y Enfermedades RespiratoriasCorrientes, ArgentinaRecruiting
  • Centro de Investigaciones Clínicas BaigorriaGranadero Baigorria, ArgentinaRecruiting
  • Instituto de Investigaciones Clínicas Mar del PlataMar del Plata, ArgentinaRecruiting
  • Instituto Médico Río CuartoRío Cuarto, ArgentinaRecruiting

And 94 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-522640-41
  • J2S-MC-GZMR
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)