Semaglutide Pen Injector 2.4mg weekly for Asthma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Vanderbilt University Medical Center, Nashville, TNAsthmaSemaglutide Pen Injector 2.4mg weekly - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether semaglutide, an FDA-approved diabetes and obesity drug, can improve asthma control in adults who are overweight and not well-controlled with inhaled steroids.

Eligible Conditions
  • Asthma

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Baseline to week 4 and week 12

Baseline to week 12
Asthma
The efficacy of semaglutide once weekly on asthma control questionnaire-6 score in subjects with symptomatic, persistent asthma and obesity
Baseline to week 24
The impact of semaglutide on weight loss over time.
The maximal dose of semaglutide tolerated in persistent asthma with obesity.
Baseline to week 26
Asthma
Baseline to week 4
The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity.
Week 12
The change in exhaled nitric oxide from semaglutide to week 12.
The change in serum periostin from semaglutide to week 12.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Study Drug (Semaglutide)
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide Pen Injector 2.4mg weekly · Has Placebo Group · Phase 2

Study Drug (Semaglutide)
Drug
Experimental Group · 1 Intervention: Semaglutide Pen Injector 2.4mg weekly · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 4 and week 12

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
784 Previous Clinical Trials
599,140 Total Patients Enrolled
12 Trials studying Asthma
4,595 Patients Enrolled for Asthma
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,172 Previous Clinical Trials
4,939,836 Total Patients Enrolled
56 Trials studying Asthma
11,094 Patients Enrolled for Asthma
Katherine Cahill, MDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
1 Trials studying Asthma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a body mass index (BMI) of 30 or higher, which is considered as obesity.
You have been diagnosed with asthma by a doctor in the past.
You have been using the same asthma medication for the past 8 weeks.

Frequently Asked Questions

Does this trial still accept participants?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively recruiting participants; the study was first posted on September 7th 2022 and recently updated on the 9th of that same month. The research seeks approximately 100 subjects from a single site." - Anonymous Online Contributor

Unverified Answer

Is the 2.4mg weekly dosage of Semaglutide Pen Injector officially sanctioned by the FDA?

"Although the efficacy of Semaglutide Pen Injector 2.4mg weekly is yet to be verified, there has been enough evidence gathered on its safety for it to receive a score of 2 out of 3." - Anonymous Online Contributor

Unverified Answer

What is the key aim of this trial?

"This clinical trial will examine the impacts of semaglutide administered weekly over a Baseline to week 12 time frame on serum periostin in subjects with symptomatic, persistent asthma and obesity. Secondary objectives include evaluating weight loss from baseline at week 24, establishing changes in exhaled nitric oxide levels between weeks 4 and 12, and measuring efficacy as indicated by ACQ-6 scores (0-6; lower is better) after twelve weeks." - Anonymous Online Contributor

Unverified Answer

How many participants are being tracked in this research study?

"Affirmative. Records on clinicaltrials.gov demonstrate that, as of 9/9/2022, this clinical research is actively seeking participants to participate at one site with a goal of 100 enrollees. The trial was initially posted the 7th September 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.