A weekly injection of tirzepatide could improve asthma control in 138 people with both asthma and obesity, if a placebo-controlled trial confirms its effectiveness. Obesity worsens asthma through mechanical pressure on the lungs and inflammation driven by fat-cell chemicals. Tirzepatide, already used for weight loss and diabetes, reduces those inflammatory signals. But no one has tested it specifically for asthma. This trial will measure whether the drug improves scores on the Asthma Control Questionnaire, lung function, body fat, and blood markers of inflammation over 32 weeks of treatment, with follow-up to 52 weeks. If tirzepatide works, it would offer a new treatment option for a large group of patients who often respond poorly to standard inhalers. The results would also clarify whether weight loss alone drives the improvement, or whether the drug has direct anti-inflammatory effects. That distinction matters for designing future phase III trials and for understanding the biological link between obesity and asthma. The team will publish the protocol and share findings through Asthma UK and press channels.
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Research question Can tirzepatide improve asthma control in people with concurrent asthma and obesity? Background Asthma and obesity are two major health crises with increasing incidence, morbidity and mortality, and significant social and healthcare costs. Obesity causes bronchoconstriction due to mechanical effects and inflammation by adipokine production. Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (Ra), reduces adipokines results in clinically meaningful weight reduction. Observational studies suggest that GLP-1 Ra improves asthma control however the efficacy of tirzepatide in asthma and obesity is unknown. Aims and Objectives To determine whether tirzepatide in people with asthma and obesity can improve asthma control (primary outcome) as measured by the 7-item Asthma Control Questionnaire (ACQ), health related quality of life, exhaled nitric oxide, body mass index, body fat and serum adipokines and cytokines. To determine whether baseline or changes in anthropometric measurements or adipokines predicts change in asthma control. Methods This is a placebo-controlled randomised parallel study of weekly tirzepatide in 138 people with poorly controlled asthma and obesity. Patients with evidence of bronchial reversibility, obesity, an ACQ > 1.5 and on stable treatment will be recruited but not those with other significant disease, diabetes treatment, history of pancreatitis or thyroid carcinoma, use of weight reduction medication or a significant smoking or alcohol history. The intervention will be once weekly subcutaneous tirzepatide 15 mg for 32 weeks as an adjunct to behavioural support following a dose up-titration from 2.5 mg weekly every four weeks over a 20-week duration. The control will be a matched placebo injection plus behavioural support. Measurements will be made at baseline, 24 weeks and 52 weeks for ACQ (primary endpoint), forced expiratory volume in 1 second, forced expiratory flow between 25% and 75% of forced vital capacity, fraction of exhaled nitric oxide, static lung volumes, laboratory weight, body fat (by bioimpedance) and waist circumference. The following will be measured at baseline, 8, 20, 28, 36, 44 and 52 weeks: ACQ-6, peak expiratory flow, asthma Quality of Life Questionnaire, 5-Level Euroqol-5-dimension questionnaire (EQ-5D-5L), waist to hip ratio and weight. Food frequency and reflux questionnaires, and serum biomarkers be measured baseline and 52 weeks. Safety bloods will be measured at baseline, 8, 20, 28, 36, 44 and 52 weeks and adverse events and concomitant medication will be captured at all visits. Timelines for delivery We will require 6 months set up, 12 months recruitment, 12 months follow-up and 6 months for analysis and dissemination. Anticipated impact and dissemination This may open a novel treatment opportunity for individuals with asthma and obesity, clarify how it may be working and explain the association between these conditions. It will provide evidence for or against a phase III trial and knowledge to design it. We will register the trial and publish the protocol. We will discuss the findings with our Public and Patient Involvement and Engagement group and disseminate the results via scientific and non-medical routes with the support of Asthma UK and our press liaison teams, using their combined outreach infrastructure.
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