Clinical trial
Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study
Name
852967
Description
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. Are we able to titrate semaglutide therapy to a target weight?
Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.
Trial arms
Trial start
2024-01-29
Estimated PCD
2024-06-28
Trial end
2024-06-28
Status
Recruiting
Phase
Early phase I
Treatment
Semaglutide Pen Injector
Once weekly subcutaneous injection
Arms:
Study Drug (semaglutide)
Other names:
Ozempic
Size
8
Primary endpoint
Tolerability
12 weeks
Eligibility criteria
Inclusion Criteria:
* 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
* Use of disease-modifying therapy
Exclusion Criteria:
* Diabetes
* Pregnant or Breastfeeding
* Recent weight loss
* Recent or chronic GI complaints
* History of gastroparesis
* History of scleroderma
* Hospitalized at time of evaluation
* Use of weight loss medication in last 90 days
* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (type 2)
* Uncontrolled thyroid disease
* History of acute/chronic pancreatitis
* Prior suicide attempt
* Suicidal ideation in last 90 days
* Presence of a pacemaker or defibrillator
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ESTIMATED'}}
Updated at
2024-01-31
1 organization
1 product
6 indications
Organization
University of PennsylvaniaProduct
SemaglutideIndication
ObesityIndication
Interstitial Lung DiseaseIndication
Chronic Obstructive Pulmonary DiseaseIndication
SarcoidosisIndication
PulmonaryIndication
Pulmonary Hypertension