Feasibility of Semaglutide in Advanced Lung Disease

Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension; Interstitial Lung Disease; Sarcoidosis, Pulmonary
• Intervention / Treatment: Drug: Semaglutide Pen Injector

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.

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Michaela R Anderson, MD; Phone Number: 215-662-3202; Email: michaela.anderson@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Perelman School of Medicine
      • Contact: Apurva Raje; Email: apurva.raje@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Drug (semaglutide); Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy	Drug: Semaglutide Pen Injector; Once weekly subcutaneous injection; Other Names: Ozempic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability	The proportion of participants who either reach a target semaglutide dose of 1.0 mg/week or who achieve target weight.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Change in percent body fat	Baseline to 12 weeks
Body composition	Change in skeletal muscle index	Baseline to 12 weeks
Body composition	Change in weight	Baseline to 12 weeks
Lung function	Change in forced vital capacity	Baseline to 12 weeks
Lung function	Change in forced expiratory volume in 1 second	Baseline to 12 weeks
Lung function	Change in diffusion capacity	Baseline to 12 weeks
Physical function	Change in frailty as measured by the Short Physical Performance Battery	Baseline to 12 weeks
Physical function	Change in six-minute walk distance	Baseline to 12 weeks
Markers of adiposity and insulin resistance	Change in c-reactive protein	Baseline to 12 weeks
Markers of adiposity and insulin resistance	Change in glycosylated hemoglobin	Baseline to 12 weeks
Markers of adiposity and insulin resistance	Change in free fatty acids	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Michaela R Anderson, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): June 28, 2024
• Study Completion (Estimated): June 28, 2024

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: semaglutide
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Disease Attributes; Hypersensitivity; Hypertension; Hypersensitivity, Delayed; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Lung Diseases, Interstitial; Sarcoidosis, Pulmonary; Sarcoidosis
• Other Study ID Numbers: 852967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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