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Feasibility of Semaglutide in Advanced Lung Disease

Plain-language guide to NCT05746039: phase 1, phase 2 interventional trial of Semaglutide, 8 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05746039
Phase
phase 1, phase 2
Status
recruiting participants
Start
2024-01-29
Completion (planned or actual)
2027-12-28
Participants
8 (estimated)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Obesity; Interstitial Lung Disease; Chronic Obstructive Pulmonary Disease; Sarcoidosis, Pulmonary; Pulmonary Hypertension
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1, phase 2) is built around Semaglutide.

The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease.

The main question\[s\] it aims to answer are: 1.

Are patients with advanced lung disease able to tolerate semaglutide therapy? 2.

It had 1 arm (groups): Study Drug (semaglutide) (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a small open-label pilot clinical trial of semaglutide in adults (age 18 or older, n=8) with obesity (BMI≥30 kg/m2), and chronic advanced lung disease (interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension requiring supplemental oxygen on exertion).

This study will evaluate medication adherence and side effects to determine semaglutide tolerability.

Markers of physical function and pulmonary function will be evaluated before therapy and after 12 weeks of therapy to determine the effect of semaglutide on function.

Measures of fat and muscle, will be performed before therapy and after 12 weeks of therapy to evaluate how semaglutide alters body composition in this population.

Who Took Part

Enrollment: 8 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Diagnosis of one of the following lung diseases: interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension. Age \> 18. BMI \> 30 kg/m2. Requires supplemental oxygen on exertion. Stable treatment regimen X 90 days.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: pregnant or breastfeeding; recent weight loss; recent or chronic gi complaints.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-01-29 with completion listed for 2027-12-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Tolerability (time frame: 12 weeks).

It also tracked 11 secondary outcomes, for example Body composition, Body composition, Body composition, Lung function, Lung function and Lung function.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Semaglutide in 8 people.

Its size is small, so on its own it can only give an early look.

It is still 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.