Recruiting

Brenipatide for Uncontrolled Moderate to Severe Asthma

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What is being tested

Brenipatide

+ Brenipatide
+ Placebo
Drug
Who is being recruted

Asthma

From 18 to 75 Years
+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 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) or
Last updated: November 4, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 22, 2025Actual 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 
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Last updated: November 4, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Asthma
Criteria
3 inclusion criteria required to participate
Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.
Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.
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
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.

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

To assess the asthma exacerbation rate.
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 117 locations
Recruiting
NewportNativeMD, Inc.Newport Beach, United StatesSee the location
Recruiting
California Medical Research AssociatesNorthridge, United States
Recruiting
Allergy & Asthma Specialists, P.S.C.Owensboro, United States
Recruiting soon
AMR ClinicalTempe, United States
Recruiting
117 Study Centers