← Human Trials & Peer-Reviewed Studies

Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)

Plain-language guide to NCT05254314: phase 2 randomized trial of Semaglutide, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05254314
Phase
phase 2
Status
active, not recruiting
Start
2022-10-11
Completion (planned or actual)
2026-09-28
Participants
100 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Asthma
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Semaglutide.

This is a randomized placebo-controlled trial of semaglutide, an FDA-approved therapy for the treatment of type 2 diabetes mellitus and obesity, in adults with symptomatic asthma despite the use of inhaled steroids and with excess body weight.

It had two arms (groups): Study Drug (Semaglutide) (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

This is a proof-of-principal randomized, double-blind, placebo-controlled, single-site clinical trial of semaglutide in adult (age 18 or older, n=100), obesity-related (BMI≥30), symptomatic asthma without type II diabetes.

This study will monitor clinical asthma symptom and quality of life questionnaires and airway function to determine the effect of semaglutide on asthma control.

Markers of respiratory tract and adipose tissue inflammation will be monitored to determine the effect of semaglutide on airway inflammation.

Study participants will be monitored for 4 weeks before assignment to treatment with the study drug for 24 weeks followed by a 2 week final monitoring period.

Who Took Part

100 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: . Subject must be able to understand and provide informed consent. Males and females age 18 or older. Obesity defined as body mass index (BMI) \>=30, or \>=27 in the setting of \>=1 weight-related comorbidity:. Clinically documented hypertension (\>130 mmHg systolic or \>85 mmHg diastolic or treatment) in the prior year or during run-in. Current obstructive sleep apnea treatment.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-10-11 with completion listed for 2026-09-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity (time frame: Baseline to week 4).

It also tracked 6 secondary outcomes, for example The impact of semaglutide on weight loss over time, Incidence of treatment-emergent adverse events from semaglutide in persistent asthma with obesity, The change in exhaled nitric oxide from semaglutide to week 12 and The change in serum periostin from semaglutide to week 12.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 100 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.