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Compares treatment options for Asthma
Official title A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
ClinicalTrials.gov ID: NCT07219173
What this study is testing
What is Brenipatide?
Brenipatide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for asthma.
Also referred to as LY3537031.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tempe, Arizona, United States
- Newport Beach, California, United States
- Northridge, California, United States
- Rolling Hills Estates, California, United States
- Colorado Springs, Colorado, United States
- Doral, Florida, United States
- Ocala, Florida, United States
- Pensacola, Florida, United States
- Tampa, Florida, United States
- Westchester, Illinois, United States
- Owensboro, Kentucky, United States
- Boston, Massachusetts, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Buenos Aires, Argentina
- Ciudad de Buenos Aires, Argentina
- Corrientes, Argentina
- Granadero Baigorria, Argentina
+ 90 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tempe, Arizona, United States; Newport Beach, California, United States; Northridge, California, United States; Rolling Hills Estates, California, United States; Colorado Springs, Colorado, United States; Doral, Florida, United States and 104 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.