RecruitingPhase 3ACTRN12624001278527

Effect of tirzepatide on asthma control in obese asthmatics aged between 18 and 80: An interventional cohort study


Sponsor

Mater Hospital

Enrollment

20 participants

Start Date

Oct 28, 2025

Study Type

Interventional

Conditions

Summary

This study is investigating if Tirzepatide (trade name Mounjaro) will improve asthma symptoms in obese patients with asthma and uncontrolled symptoms. This drugs causes weight loss using glucagon like peptide (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP); to make people feel fuller for longer. Patients will be enrolled in a prospective observational cohort trial stratified for metabolic syndrome. Although improvement in asthma control is the primary outcome, secondary outcome measures include changes in serum inflammatory markers. This is because its thought that obesity causes asthma by increasing background systemic inflammation. Inflammatory markers will be measured before during and after treatment with Tirzepatide looking to see how inflammation changes with therapy. The hypothesis is that obesity associated inflammation is correlated with poor asthma control and asthma control will improve with therapy alongside a reduction in serum systemic inflammatory markers.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

Asthma and obesity often occur together, and many people with both conditions find their asthma is harder to control. Researchers believe obesity causes ongoing low-level inflammation throughout the body, which may be a key driver of worsening asthma symptoms. This study is investigating whether tirzepatide — a weight-loss medication sold as Mounjaro — can improve asthma control in people with obesity by reducing both weight and inflammation. Participants in this observational cohort trial will receive tirzepatide and be monitored over time for changes in their asthma symptoms, lung function, and blood markers of inflammation. The study will also explore how the medication interacts with existing asthma treatments, including biologics. You may be eligible if you are aged 18 to 80, have a doctor-confirmed diagnosis of asthma with uncontrolled symptoms (even if you are on treatment), and have a BMI over 30. People who are already using a GLP-1 medication, have type 1 diabetes, take insulin, have had pancreatitis, or are pregnant are not eligible. Willingness to attend clinic visits and have blood tests is required.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Tirzepatide 2.5mg administered subcutaneously weekly First dose administered under supervision, all subsequent doses to be self-administered Assessment for tolerability at 4 weeks If no grade 2 or

Tirzepatide 2.5mg administered subcutaneously weekly First dose administered under supervision, all subsequent doses to be self-administered Assessment for tolerability at 4 weeks If no grade 2 or 3 side effects, then dose escalation by 2.5mg to; 5mg administered subcutaneously weekly Assessment at 4 weeks as above Dose escalation will occur in a similar fashion, every 4 weeks until a maximum dose of 10mg is achieved Assessment of compliance completed monthly with either phone or face-to-face assessment. Trial participants will be asked directly regarding medical compliance. Any noncompliance will be recorded by the clinical trial officer. Total duration of treatment will be 48 weeks


Locations(1)

Mater Hospital Brisbane - South Brisbane

QLD, Australia

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ACTRN12624001278527


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