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Glucagon-like peptide-1 receptor agonist

Semaglutide for Lung Disease

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
Must not have
Hospitalized at time of evaluation
Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (type 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently in the hospital.
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I or my family have a history of medullary thyroid cancer or MEN type 2.
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I have a history of pancreatitis.
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I have a history of delayed stomach emptying.
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I have not taken weight loss medication in the last 90 days.
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I have not had thoughts of suicide in the last 90 days.
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I have a history of scleroderma.
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My thyroid condition is not under control.

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

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

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220
26%
Nasopharyngitis
9%
Constipation
7%
Influenza
5%
Diabetic retinopathy
5%
Nausea
4%
Gastrooesophageal reflux disease
3%
Back pain
3%
Upper respiratory tract inflammation
2%
Abdominal discomfort
2%
Vomiting
2%
Diarrhoea
1%
Cardiac ablation
1%
Herpes zoster
1%
Ischaemic cerebral infarction
1%
Acute myocardial infarction
1%
Appendicitis
1%
Large intestine polyp
1%
Peritonitis
1%
Sudden hearing loss
1%
Rectal adenocarcinoma
1%
Spinal operation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg
Dulaglutide 0.75 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,079 Previous Clinical Trials
42,721,391 Total Patients Enrolled
Michaela R Anderson, MDPrincipal InvestigatorUniversity of Pennsylvania
~1 spots leftby Dec 2024
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