Recruiting

Brenipatide for Uncontrolled Moderate to Severe Asthma

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What is being tested

Brenipatide

+ Placebo

Drug
Who is being recruted

Asthma+6

+ Bronchial Diseases

+ Hypersensitivity

From 18 to 75 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 22, 2025

Actual date on which the first participant was enrolled.

This study is exploring how effective and safe a medicine called brenipatide is for adults who have moderate to severe asthma that isn't well-controlled. Asthma can make it difficult to breathe and can greatly impact daily life. By testing different doses of brenipatide against a placebo (a substance with no active medicine), researchers aim to find out if this new treatment can help manage asthma symptoms better. This is important because finding new treatments could improve the quality of life for those struggling with asthma that current medications do not adequately control. Participants in the study will be involved for about 65 weeks, which includes different stages like screening to see if they qualify, a period where they receive the treatment, and a follow-up phase to monitor their progress. Brenipatide will be given to participants, but some will receive a placebo to compare the results effectively. The study evaluates how well brenipatide works and checks for any side effects, ensuring the treatment is safe and beneficial. This approach helps determine the right dosage and assesses the overall impact on asthma symptoms.

Official TitleA 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 
NCT07219173
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

531 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract Diseases

Criteria

3 inclusion criteria required to participate
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.
3 exclusion criteria prevent from participating
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.
An established diagnosis of occupational asthma
Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Brenipatide administered subcutaneously (SC)

Group II

Experimental
Brenipatide administered SC.

Group III

Placebo
Placebo administered SC.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 120 locations

Recruiting

AMR Clinical

Tempe, United StatesSee the location
Recruiting

NewportNativeMD, Inc.

Newport Beach, United States
Recruiting

California Medical Research Associates

Northridge, United States
Recruiting

Peninsula Research Associates

Rolling Hills Estates, United States
Recruiting
120 Study Centers