Feasibility of Semaglutide in Advanced Lung Disease

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diabetes

Pregnant or Breastfeeding

Recent weight loss

Recent or chronic GI complaints

Trial design

Design model

Single group

Treatments tested in this trial

  • Semaglutide Pen Injector

    Drug

    Once weekly subcutaneous injection

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: Study Drug (semaglutide)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

1

Body composition

Change in percent body fat

Time frame
Baseline to 12 weeks
2

Body composition

Change in skeletal muscle index

Time frame
Baseline to 12 weeks
3

Body composition

Change in weight

Time frame
Baseline to 12 weeks
4

Lung function

Change in forced vital capacity

Time frame
Baseline to 12 weeks

Other outcomes

Sponsors and contacts

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