Exploring the anti-aging effects of Metformin in COPD

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Instituto De Investigacion Sanitaria De Navarra

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

8 Apr 2026 → ongoing

Decision date (initial)

2025-11-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-520972-24-00

ClinicalTrials.gov

NCT06999343

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To compare the change in FEV1 at 3 years of follow-up in patients receiving metformin vs. placebo.

Secondary objectives 6

1. To determine whether treatment with metformin versus placebo reduces the natural progression of emphysema measured as a percentage of lung volume affected with emphysema.
2. To determine changes in the COPD assessment test, the COPD Assessment Test (CAT), a questionnaire that assesses respiratory symptoms associated with quality of life, number of annual exacerbations, physician visits, hospitalizations, and body mass index (B), obstruction (O), dyspnea (D) and exercise capacity (E) or BODE index, at 3 years of follow-up over time in patients receiving metformin vs. placebo.
3. To investigate changes in 6-minute walking distance and dominant hand grip strength at 3-year follow-up over time in patients receiving metformin vs. placebo.
4. To determine the incidence of lung cancer and other solid tumors at 3 years of follow-up over time in patients receiving metformin vs. placebo.
5. To determine the incidence of myocardial infarction, new angina, stroke, renal function impairment (microalbuminuria) at 3 years of follow-up in patients receiving metformin vs placebo.
6. Identify biological changes associated with decreased lung function that respond to metformin treatment.

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Sign the informed consent prior to any study-specific procedure.
2. Male or female, 40 to 75 years of age, inclusive, at the time of selection.
3. Have a clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2022 with a post-bronchodilator FEV1/FVC <0.7 at screening (Visit 1).
4. Have a post-bronchodilator FEV1> 40% ≤70% of the predicted value at screening (Visit 1).
5. Having a smoking history of more than 10 pack-years ([number of cigarettes smoked per day x number of years smoked]/20).
6. Must have been able to understand and meet the requirements of the study, in the judgment of the Investigator.
7. Emphysema (centrolobulillar) reported by an expert radiologist.
8. Have a certified drop in lung function in the last 3 years >40ml/ml per year of FEV1.
9. Women of childbearing age with negative pregnancy test.

Exclusion criteria 14

1. Participation in another clinical trial with any marketed or investigational biologic drug within 4 months prior to screening.
2. Patients taking oral corticosteroids chronically.
3. History of respiratory tract infection (including upper respiratory tract) and/or pulmonary exacerbation within 6 weeks prior to screening.
4. Lung resection or lung volume reduction surgery within 12 months prior to screening (Visit 1), or history of lung transplantation or, in the opinion of the investigator, the patient may have required thoracotomy or other lung surgery during the study.
5. Known active tuberculosis.
6. History of interstitial lung or massive pulmonary thromboembolic disease.
7. History of bronchiectasis secondary to respiratory diseases other than COPD (e.g., cystic fibrosis, Kartagener's syndrome, etc.).
8. Any clinically significant disease or disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal (GFR < 30 ml/min) neurologic, musculoskeletal, endocrine, metabolic, psychiatric, and major physical impairment) that, in the opinion of the investigator, could have placed the patient at risk for study participation, could have influenced the study results, or could have affected the patient's ability to participate in the study.
9. Recent history (within 12 months prior to screening [Visit 1]) of myocardial infarction, recent history of heart failure (New York Heart Association [NYHA] classes III and IV), pulmonary edema, and/or cardiac arrhythmia.
10. History of cancer (within 5 years prior to Visit 1), except non-metastatic skin cancer and non-melanoma.
11. Patients who cannot perform spirometry maneuvers or tolerate plethysmography.
12. Contraindications for the use of metformin: allergy to the drug or excipients of the same or placebo, advanced renal insufficiency (CKD stage 3 and higher), patient on dialysis, chronic metabolic or respiratory acidosis or liver cirrhosis.
13. Patients with type 2 Diabetes Mellitus with or without previous use of metformin.
14. Pregnant women, nursing mothers or women of childbearing age who are not going to use contraceptive methods.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in FEV1 at baseline and 3-year follow-up.

Secondary endpoints 17

1. Age
2. Sex at birth
3. Height
4. Baseline weight and annually until the end of follow-up.
5. Baseline smoking status.
6. Blood tests at baseline and annually until the end of follow-up.
7. Urinalysis with baseline renal function and annually until the end of follow-up.
8. Baseline and 3-year microbiota analysis.
9. Percentage of lung volume affected with emphysema at baseline and 3-year follow-up.
10. COPD assessment test (CAT), baseline and every 6 months until the end of follow-up.
11. mMRC scale at baseline and annually until the end of follow-up.
12. Number of annual exacerbations, doctor visits, hospitalisations.
13. BODE index at baseline and annually until the end of follow-up.
14. 6 minutes walking test (6MWD) at baseline and annually until the end of follow-up.
15. Hand grip strength of the dominant hand baseline and annually until the end of follow-up.
16. Incidence of lung cancer and other solid tumours throughout follow-up.
17. Incidence of myocardial infarction, new angina, stroke, renal failure throughout follow-up.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Instituto De Investigacion Sanitaria De Navarra

Sponsor organisation

Fundacion Instituto De Investigacion Sanitaria De Navarra

Address

Irunlarrea Kalea 3

City

Pamplona

Postcode

31008

Country

Spain

Scientific contact point

Organisation

Fundacion Instituto De Investigacion Sanitaria De Navarra

Contact name

Alberto Labiano Tabar

Public contact point

Organisation

Fundacion Instituto De Investigacion Sanitaria De Navarra

Contact name

Alberto Labiano Tabar

Locations

1 EU/EEA country · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications