RENEW-Asthma

RecruitingPhase 2

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

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

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

120

Recruiting sites

112

Estimated enrollment

531

Study population

Asthma

Eligibility highlights

Primary endpoint

•Annualized Asthma Exacerbation Rate

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07219173

Org study ID27744

Secondary ID2025

Secondary ID2025-522640-41

Secondary IDJ2S-MC-GZMREli Lilly and Company

Timeline

Milestones

Study first posted2025-10-21actual

Study start2025-10-22actual

Last update posted2026-11-05actual

Primary completion2028-04estimated (month precision)

Study completion2028-06estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

Asthma

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline up to Week 52

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Baseline to Week 52

threshold achievement, event

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment

Time frame:Baseline to Week 52

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Patient Reported Health Outcomes

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Time to First Exacerbation

Time frame:Baseline to Week 52

time to event, event

Secondary/protocol endpoint/low confidence

Change from Baseline in Weekly Mean Rescue Medication Use

Time frame:Baseline, Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.