A Phase 2 interventional study of Brenipatide and Brenipatide in Asthma, sponsored by Eli Lilly and Company. Recruiting at 120 sites in 12 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 531 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Known pre-existing, lung condition other than asthma, including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brenipatide administered subcutaneously (SC)
Drug: Brenipatide
Brenipatide administered SC.
Drug: Brenipatide
Placebo administered SC.
Drug: Placebo
Administered SC
Also known as: LY3537031
Administered SC
Also known as: LY3537031
Administered SC
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
To assess the asthma exacerbation rate.
Time frame: Baseline to Week 52
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline, Week 52
Change from Baseline in Patient Reported Health Outcomes
Time frame: Baseline, Week 52
Time to First Exacerbation
Time frame: Baseline to Week 52
Change from Baseline in Weekly Mean Rescue Medication Use
Time frame: Baseline, Week 52
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Baseline up to Week 52
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)
Time frame: Baseline to Week 52
Showing the first 100 of 120 sites across 12 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement. URL: https://vivli.org/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Apr 2028, 30 months after the start.
Of 137 industry-sponsored phase 2 interventional studies under Asthma, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's planned 30 months is above that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Brenipatide