> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-brenipatide-compared-with-placebo-in-f8e92582-8a43-48c0-a76a-aa9731fc7cda > Record changed: 2026-11-04 # A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma NCT07219173 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) Participants 531 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) Start date 2025-10-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) Number of sites 119 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Acronym** RENEW-Asthma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Short title** A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Dates **Completion date** 2028-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **First posted** 2025-10-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Registry last updated** 2026-10-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Primary completion date** 2028-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Start date** 2025-10-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Size and sites **Participants** 531 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Planned participants** 531 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Number of sites** 119 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Identifiers **Registry ID** NCT07219173 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **ClinicalTrials.gov ID** NCT07219173 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Care providers Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Outcomes ### Primary outcomes 1. Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment Timeframe: Baseline to Week 52 To assess the asthma exacerbation rate. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## References ### Other registry identifiers (3) - 2025 - 2025-522640-41 - J2S-MC-GZMR Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07219173) ## Related records ### Drugs (1) - [Brenipatide](https://trialight.com/data/asset/brenipatide-4758d77a-80b3-5d20-93d3-fc5bfaf5857c.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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