Effects of Liraglutide in Chronic Obstructive Pulmonary Disease

NCT03466021 | Completed Phase 4 DMC

• 1 other identifier: U1111-1188-8695
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The study is a 44 weeks, prospective, randomized, placebo-controlled, double-blinded, parallel group two-center trial. Forty patients are recruited among the outpatients of the chronic obstructive pulmonary disease (COPD) clinic, Hospital of South West Jutland and Lillebælt Hospital according to the inclusion and exclusion criteria. The patients are randomized to receive liraglutide 3 mg per day (initial dose 0.6 mg, increasing by 0.6 mg weekly until 3 mg is reached) or placebo. At baseline, after four weeks (assessment of the acute effect of liraglutide), 20 weeks, and 40 weeks (assessment of the combined effect of liraglutide and weight loss) and at week 44 (assessment of the weight-loss after discontinuation of liraglutide) the patients are assessed by physical examination, carbon monoxide (CO) diffusion test, pulmonary function test, biomarkers of inflammation (CRP, interleucine-6 (IL-6), monocyte chemitactic protein-1 (MCP-1)), Fluorodeoxyglucose (FDG)/PET-CT scan of the lungs, 6-minute walking test, respiratory polygraphy and validated questionnaires including basic dyspnea index, transition dyspnea index, COPD Assessment Test (CAT)-score, short-form-36 (SF-36) and Epworth Sleepiness Score.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

GLP-1 receptor agonist; Chronic obstructive pulmonary disease; FDG/PET-CT; inflammation; weightloss; quality of life

Outcome Measures

Primary Outcomes (1)

• Transition Dyspnea Index (TDI)

  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). A positive value indicates less dyspnea during specified activities

  40 weeks

Secondary Outcomes (19)

• 6 minutes walking test

  44 weeks

• Diffusion capacity of the lung for carbon monoxide (DLCO)

  44 weeks

• FEV1/FVC

  44 weeks

• Total lung capacity (TLC)

  44 weeks

• Residual volume (RV)

  44 weeks

Study Arms (2)

Liraglutide

ACTIVE COMPARATOR

Liraglutide injection 3.0 mg daily

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

Placebo, matching injection pen

Drug: Placebo

Interventions

Liraglutide DRUG

Initially 0.6 mg daily, increasing weekly with 0.6 mg, until 3.0 mg is reached.

Also known as: Saxenda, NN2211

Liraglutide

Placebo DRUG

Matching injection

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any trial-related activities
• COPD as defined by FEV1/FVC\<70% after maximal broncho-dilatation and in accordance with the Gold guidelines 2017 (25)
• Previous smoking of ≥ 20 pack-years
• Overweight defined as BMI \> 27 kg/m2
• Age 30 - 75 years
• Women of childbearing potential must use a safe anti-contraceptive method

You may not qualify if:

• Chronic treatment with systemic steroids (inhalation steroids allowed)
• Current smokers
• Diabetes mellitus type 1 and type 2 as defined by current or previous treatment with antidiabetic medications of any kind or HbA1c ≥ 48mmol/mol
• Severe hepatic disease (Alanine transferase \> 3 x UNL)
• Severe impaired renal function (eGFR \< 30ml/min)
• Congestive heart disease New York Heart Association (NYHA) class 3-4
• History of acute or chronic pancreatitis
• History of cholecystitis or cholecystolithiasis
• Pregnant or breastfeeding women
• Known bronchial asthma or interstitial lung disease
• Family history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma
• Large goiter or plasma-calcitonin \> 50ng/ml

Sponsors & Collaborators

• Claus Bogh Juhl: lead

Study Sites (2)

Hospital of South West Jutland

Esbjerg, 6700, Denmark

Location

Lillebaelt Hospital

Vejle, 7100, Denmark

Location

Related Publications (1)

• Dogan ADA, Christensen TQ, Jensen TT, Juhl CB, Hilberg O, Bladbjerg EM, Hess S. FDG-PET/CT-based respiration-gated lung segmentation and quantification of lung inflammation in COPD patients. BMC Res Notes. 2024 Jun 20;17(1):170. doi: 10.1186/s13104-024-06820-w.

  PMID: 38902794 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation; Weight Loss

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Claus B Juhl, MD PhD

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD. ph.d

Model Details: A prospective, randomized, placebo-controlled, double-blinded, parallel group and two-center trial.

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 15, 2018
• Study Start: January 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

DK (2)