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Glucagon-like peptide-1 receptor agonist

Study Drug (semaglutide) for Obesity

Phase 1 & 2
Recruiting
Led By Michaela R Anderson, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requires supplemental oxygen on exertion
Diagnosis of one of the following lung diseases: interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is studying whether semaglutide, a treatment for diabetes and obesity, is safe and well-tolerated in patients with advanced lung disease. The trial will measure lung function, physical function

Who is the study for?
This trial is for adults over 18 with a BMI above 30 who have advanced lung diseases like interstitial lung disease, sarcoidosis, COPD, or pulmonary hypertension. They should need extra oxygen when active and have been on stable treatment for the last 90 days.Check my eligibility
What is being tested?
The study tests if semaglutide, usually used for diabetes and obesity, is safe and manageable for patients with severe lung conditions. It checks their ability to tolerate the drug and reach target weight loss over a period of 12 weeks.See study design
What are the potential side effects?
Possible side effects include digestive issues such as nausea or diarrhea, changes in appetite, risk of low blood sugar levels (hypoglycemia), fatigue, headache, and potential injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need extra oxygen when I move around.
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I have been diagnosed with a specific lung condition.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tolerability
Secondary outcome measures
Body composition
Lung function
Markers of adiposity and insulin resistance
+1 more

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220
29%
Nasopharyngitis
9%
Constipation
9%
Nausea
8%
Upper respiratory tract inflammation
6%
Back pain
6%
Diarrhoea
5%
Decreased appetite
3%
Influenza
3%
Diabetic retinopathy
2%
Atrioventricular block second degree
2%
Abdominal discomfort
2%
Vomiting
2%
Angina pectoris
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dulaglutide 0.75 mg
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study Drug (semaglutide)Experimental Treatment1 Intervention
Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,279 Total Patients Enrolled
87 Trials studying Obesity
72,459 Patients Enrolled for Obesity
Michaela R Anderson, MDPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study open to individuals below the age of 70?

"To be eligible for this trial, individuals must fall within the age range of 18 to 80. Specifically, there are a total of 225 trials available for participants under the age of 18 and an additional 1159 trials targeting individuals over the age of 65."

Answered by AI

Are there any current openings for participants in this ongoing clinical trial?

"According to the information available on clinicaltrials.gov, this ongoing clinical trial is currently actively seeking eligible participants. The initial posting date for the trial was January 29, 2024, and it has been most recently updated or edited on the same day as well."

Answered by AI

What is the current number of individuals involved in this clinical trial as participants?

"Indeed, the information provided on clinicaltrials.gov confirms that this clinical trial is currently actively seeking participants. The initial posting date was January 29th, 2024, and the most recent update also occurred on January 29th, 2024. The trial aims to recruit a total of eight individuals from one specific location."

Answered by AI

Which individuals meet the criteria to be considered as potential candidates for enrollment in this clinical trial?

"To be eligible for this research, potential participants must have a diagnosis of interstitial lung disease and fall within the age range of 18 to 80. The study has limited capacity and will only enroll a maximum of 8 individuals."

Answered by AI

Who else is applying?

What site did they apply to?
University of Pennsylvania Perelman School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have never tried any Weight Loss drugs, but I have gained a significant amount of weight due to menopause and an operation.
PatientReceived no prior treatments
~2 spots leftby Jun 2024