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Exploring the anti-aging effects of Metformin in COPD
EU CTIS ID: 2025-520972-24-00
What this study is testing
To compare the change in FEV1 at 3 years of follow-up in patients receiving metformin vs. placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Sign the informed consent prior to any study-specific procedure.
- Male or female, 40 to 75 years of age, inclusive, at the time of selection.
- 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).
- Have a post-bronchodilator FEV1> 40% ≤70% of the predicted value at screening (Visit 1).
- Having a smoking history of more than 10 pack-years ([number of cigarettes smoked per day x number of years smoked]/20).
- Must have been able to understand and meet the requirements of the study, in the judgment of the Investigator.
You likely can't join if
- Participation in another clinical trial with any marketed or investigational biologic drug within 4 months prior to screening.
- History of cancer (within 5 years prior to Visit 1), except non-metastatic skin cancer and non-melanoma.
- Patients who cannot perform spirometry maneuvers or tolerate plethysmography.
- 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.
- Patients with type 2 Diabetes Mellitus with or without previous use of metformin.
- Pregnant women, nursing mothers or women of childbearing age who are not going to use contraceptive methods.
See the full eligibility criteria
Who can join
- Sign the informed consent prior to any study-specific procedure.
- Male or female, 40 to 75 years of age, inclusive, at the time of selection.
- 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).
- Have a post-bronchodilator FEV1> 40% ≤70% of the predicted value at screening (Visit 1).
- Having a smoking history of more than 10 pack-years ([number of cigarettes smoked per day x number of years smoked]/20).
- Must have been able to understand and meet the requirements of the study, in the judgment of the Investigator.
- Emphysema (centrolobulillar) reported by an expert radiologist.
- Have a certified drop in lung function in the last 3 years >40ml/ml per year of FEV1.
- Women of childbearing age with negative pregnancy test.
What rules you out
- Participation in another clinical trial with any marketed or investigational biologic drug within 4 months prior to screening.
- History of cancer (within 5 years prior to Visit 1), except non-metastatic skin cancer and non-melanoma.
- Patients who cannot perform spirometry maneuvers or tolerate plethysmography.
- 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.
- Patients with type 2 Diabetes Mellitus with or without previous use of metformin.
- Pregnant women, nursing mothers or women of childbearing age who are not going to use contraceptive methods.
- Patients taking oral corticosteroids chronically.
- History of respiratory tract infection (including upper respiratory tract) and/or pulmonary exacerbation within 6 weeks prior to screening.
- 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.
- Known active tuberculosis.
- History of interstitial lung or massive pulmonary thromboembolic disease.
- History of bronchiectasis secondary to respiratory diseases other than COPD (e.g., cystic fibrosis, Kartagener's syndrome, etc.).
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.