Effects of Saxenda (R) on respiratory function in obese patients with chronic obstructive lung disease

Effects of GLP-1 receptor agonist treatment on pulmonary function and quality of life in obese patients with chronic obstructive pulmonary disease - A prospective, randomized, placebo-controlled, double-blinded, parallel group, two-center trial for the evaluation of the effect of Liraglutide 3 mg daily on chronic obstructive pulmonary disease. - Liraglutide in COPD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003551-32-DK

Enrollment

Registered

2017-11-22

Start date

2017-11-01

Completion date

Unknown

Last updated

2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease in obese subjects MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Saxenda Product Name: Saxenda Pharmaceutical Form: Injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent obtained before any trial-related activities 2. COPD as defined by FEV1/FVC 27 kg/m2 5. Age 30 – 75 years 6. Women of childbearing potential must use a safe anti-contraceptive method Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Chronic treatment with systemic steroids (inhalation steroids allowed) 2. Current smokers 3. Diabetes mellitus type 1 and type 2 as defined by current or previous treatment with antidiabetic medications of any kind or HbA1c = 48mmol/mol 4. Severe hepatic disease (Alanine transferase > 3 x UNL) 5. Severe impaired renal function (eGFR 50ng/ml

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to evaluated the effect of Liraglutide 3mg on patient reported outcomes and objective measures of COPD;Secondary Objective: NA;Primary end point(s): The primary objective is to evaluate the effect of Liraglutide 3mg on Transition Dyspnea Index (TDI) after 40 weeks of treatment in subjects with COPD and overweight (BMI>27 kg/m2).;Timepoint(s) of evaluation of this end point: 0, 4, 20, 40 and 44 weeks	—

Measure

Time frame

Main Objective: The objective of the study is to evaluated the effect of Liraglutide 3mg on patient reported outcomes and objective measures of COPD;Secondary Objective: NA;Primary end point(s): The primary objective is to evaluate the effect of Liraglutide 3mg on Transition Dyspnea Index (TDI) after 40 weeks of treatment in subjects with COPD and overweight (BMI>27 kg/m2).;Timepoint(s) of evaluation of this end point: 0, 4, 20, 40 and 44 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1. walking distance during a 6-minutes walking test 2. pulmonary diffusion capacity as measured by carbon monoxid (CO) diffusion test providing a measure of pulmonary CO diffusion capacity and CO diffusion capacity divided by alveolar volume (DLCO/VA) 3. forced expiratory volume in first second (FEV1)/forced vital capacity (FVC) as measured by spirometry total lung capacity (TLC), residual volume (RV) and DLCO/VA 4. COPD Assessment Test (CAT)-score 5. SF-36 quality of life questionnaire score 6. markers of inflammation: CRP, IL-6 and MCP-1 7. pulmonary inflammation as assessed by PET/CT using semiquantitative and quantitative measures of radioactive distribution: SUVmax, SUVmean, TLG 8. body weight 9. Number of COPD exacerbations as defined by: Mild-moderate exacerbations: Treatment with antibiotics or/and oral prednisolone and Moderate-severe exacerbations: Hospitalization due to pulmonary symptoms. 10. Changes in use of bronchodilator drugs and anti-inflammatory drugs as defined by an increase in beta2agonists of more than 20 % per week and a change of more than 20 % of dose of anti-inflammatory drugs respectively. 11. Apnea/hypopnea index 12. Oxygen desaturation index (ODI) 13. Epworth score;Timepoint(s) of evaluation of this end point: 0, 4, 20, 40 and 44 weeks	—

Measure

Time frame

Secondary end point(s): 1. walking distance during a 6-minutes walking test 2. pulmonary diffusion capacity as measured by carbon monoxid (CO) diffusion test providing a measure of pulmonary CO diffusion capacity and CO diffusion capacity divided by alveolar volume (DLCO/VA) 3. forced expiratory volume in first second (FEV1)/forced vital capacity (FVC) as measured by spirometry total lung capacity (TLC), residual volume (RV) and DLCO/VA 4. COPD Assessment Test (CAT)-score 5. SF-36 quality of life questionnaire score 6. markers of inflammation: CRP, IL-6 and MCP-1 7. pulmonary inflammation as assessed by PET/CT using semiquantitative and quantitative measures of radioactive distribution: SUVmax, SUVmean, TLG 8. body weight 9. Number of COPD exacerbations as defined by: Mild-moderate exacerbations: Treatment with antibiotics or/and oral prednisolone and Moderate-severe exacerbations: Hospitalization due to pulmonary symptoms. 10. Changes in use of bronchodilator drugs and anti-inflammatory drugs as defined by an increase in beta2agonists of more than 20 % per week and a change of more than 20 % of dose of anti-inflammatory drugs respectively. 11. Apnea/hypopnea index 12. Oxygen desaturation index (ODI) 13. Epworth score;Timepoint(s) of evaluation of this end point: 0, 4, 20, 40 and 44 weeks

—

Countries

Denmark

Contacts

Public ContactMedical Department

Hospital of South West Jutland

claus.bogh.juhl@rsyd.dk4560867172

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026