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Feasibility of Semaglutide in Advanced Lung Disease

Primary Purpose

Obesity, Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Semaglutide Pen Injector
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring semaglutide

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Study Drug (semaglutide)

    Arm Description

    Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy

    Outcomes

    Primary Outcome Measures

    Tolerability
    The proportion of participants who either reach a target semaglutide dose of 1.0 mg/week or who achieve target weight.

    Secondary Outcome Measures

    Body composition
    Change in percent body fat
    Body composition
    Change in skeletal muscle index
    Body composition
    Change in weight
    Lung function
    Change in forced vital capacity
    Lung function
    Change in forced expiratory volume in 1 second
    Lung function
    Change in diffusion capacity
    Physical function
    Change in frailty as measured by the Short Physical Performance Battery
    Physical function
    Change in six-minute walk distance
    Markers of adiposity and insulin resistance
    Change in c-reactive protein
    Markers of adiposity and insulin resistance
    Change in glycosylated hemoglobin
    Markers of adiposity and insulin resistance
    Change in free fatty acids

    Full Information

    First Posted
    February 2, 2023
    Last Updated
    October 17, 2023
    Sponsor
    University of Pennsylvania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05746039
    Brief Title
    Feasibility of Semaglutide in Advanced Lung Disease
    Official Title
    Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 15, 2023 (Anticipated)
    Primary Completion Date
    June 28, 2024 (Anticipated)
    Study Completion Date
    June 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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: Are patients with advanced lung disease able to tolerate semaglutide therapy? 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.
    Detailed Description
    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. Study participants will be monitored for 12 weeks while receiving semaglutide therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Sarcoidosis, Pulmonary, Pulmonary Hypertension
    Keywords
    semaglutide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Drug (semaglutide)
    Arm Type
    Experimental
    Arm Description
    Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy
    Intervention Type
    Drug
    Intervention Name(s)
    Semaglutide Pen Injector
    Other Intervention Name(s)
    Wegovy
    Intervention Description
    Once weekly subcutaneous injection
    Primary Outcome Measure Information:
    Title
    Tolerability
    Description
    The proportion of participants who either reach a target semaglutide dose of 1.0 mg/week or who achieve target weight.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Body composition
    Description
    Change in percent body fat
    Time Frame
    Baseline to 12 weeks
    Title
    Body composition
    Description
    Change in skeletal muscle index
    Time Frame
    Baseline to 12 weeks
    Title
    Body composition
    Description
    Change in weight
    Time Frame
    Baseline to 12 weeks
    Title
    Lung function
    Description
    Change in forced vital capacity
    Time Frame
    Baseline to 12 weeks
    Title
    Lung function
    Description
    Change in forced expiratory volume in 1 second
    Time Frame
    Baseline to 12 weeks
    Title
    Lung function
    Description
    Change in diffusion capacity
    Time Frame
    Baseline to 12 weeks
    Title
    Physical function
    Description
    Change in frailty as measured by the Short Physical Performance Battery
    Time Frame
    Baseline to 12 weeks
    Title
    Physical function
    Description
    Change in six-minute walk distance
    Time Frame
    Baseline to 12 weeks
    Title
    Markers of adiposity and insulin resistance
    Description
    Change in c-reactive protein
    Time Frame
    Baseline to 12 weeks
    Title
    Markers of adiposity and insulin resistance
    Description
    Change in glycosylated hemoglobin
    Time Frame
    Baseline to 12 weeks
    Title
    Markers of adiposity and insulin resistance
    Description
    Change in free fatty acids
    Time Frame
    Baseline to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michaela R Anderson, MD
    Phone
    215-662-3202
    Email
    michaela.anderson@pennmedicine.upenn.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michaela R Anderson, MD
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Feasibility of Semaglutide in Advanced Lung Disease

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