RightFit
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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe brenipatide is and how well different doses work compared with a placebo, a treatment with no active study drug. It is for adults with moderate to severe asthma that is not well controlled. Taking part lasts about 65 weeks, including screening, treatment, and follow-up.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have asthma diagnosed by a doctor and have received prescribed medicine to control it for at least 12 months before screening.
  • Have a score of 1.5 or higher on the ACQ-6 asthma control survey at 2 of 3 visits before being assigned to a study group.
  • Have had at least 1 severe asthma flare-up in the 12 months before screening that needed steroid medicine acting throughout the body.

Who can't join

  • Have asthma caused by something at work.
  • Have another important lung condition, such as a long-lasting lung infection, damaged or widened airways, or lung scarring.
  • Have a lung allergy to Aspergillus fungus.
  • Have emphysema, chronic bronchitis, or chronic obstructive pulmonary disease (COPD), which can damage the lungs or make breathing hard.
  • Have eosinophilic granulomatosis with polyangiitis, a disease that causes swelling in blood vessels.
  • Have another condition that acts like asthma, such as vocal cords that do not work properly.
  • Have a current or recent active infection during the 30 days before screening or between screening and assignment to a study group.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (17)

AZ

CA

CO

FL

IL

KY

MA

  • Brigham and Women's Hospital · Boston, MA 02115Dinah Foer · Principal investigatorMore trials in Boston

NV

NY

PA

TN

  • Vanderbilt Asthma, Sinus and Allergy Program · Nashville, TN 37203Ashley Wu · Principal investigatorMore trials in Nashville