Feasibility of Semaglutide in Advanced Lung Disease

NCT05746039 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 852967
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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:

1. 1.Are patients with advanced lung disease able to tolerate semaglutide therapy?
2. 2.Are we able to titrate semaglutide therapy to a target weight?

Conditions

Obesity; Interstitial Lung Disease; Chronic Obstructive Pulmonary Disease; Sarcoidosis, Pulmonary; Pulmonary Hypertension

Keywords

semaglutide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Body composition

  Baseline to 12 weeks

• Body composition

  Baseline to 12 weeks

• Body composition

  Baseline to 12 weeks

• Lung function

  Baseline to 12 weeks

• Lung function

  Baseline to 12 weeks

Study Arms (1)

Study Drug (semaglutide)

EXPERIMENTAL

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

Drug: Semaglutide Pen Injector

Interventions

Semaglutide Pen Injector DRUG

Once weekly subcutaneous injection

Also known as: Ozempic

Study Drug (semaglutide)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive; Sarcoidosis, Pulmonary; Hypertension, Pulmonary

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michaela R Anderson, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michaela R Anderson, MD

CONTACT

215-662-3202; michaela.anderson@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 27, 2023
• Study Start: January 29, 2024
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)