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COPDPhase 3AMICONCT06999343

Exploring the Anti-ageing Effects of Metformin in COPD

A Phase 3 study testing Metformin 850Mg Tab in people with COPD, run by Fundación Instituto de Investigación Sanitaria de Navarra.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Prospective, multicentre, double-blind, placebo-controlled, randomised, prospective clinical trial comparing the effect of metformin 850 mg twice daily with placebo in COPD patients with evidence of emphysema (by CT scan or reduced DLCO) who are known to have a rapid decrease in FEV1. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
COPD
What is being tested?
Metformin 850Mg Tab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
212 participants
Where
No sites listed yet
Study dates
1 Sep 2025to 1 Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign the informed consent form prior to any study-specific procedure.
  • Male or female, aged 40 to 75 years, inclusive, at the time of Screening.
  • Have a COPD clinic diagnostic according to Global Initiative for 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)
  • 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 comply with the requirements of the study, as judged by the investigator.
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  • Have some kind of emphysema (centrolobulillar or paraseptal) reported by an expert radiologist.
  • Have a certified decrease of the Lung Function in the last 3 years >40 ml/ml per year of FEV1.
  • Women in childbearing age with negative pregnancy test.

Who cannot join

  • Participating in another clinic trial with any commercially or investigational biological medicinal product within 4 months prior to Screening.
  • Patients who take oral corticosteroids chronically.
  • Respiratory track infection history (superior respiratory tract included) and pulmonary exarcerbation within 6 weeks prior to Screening.
  • Lung resection or lung volume reduction surgery within 12 months prior to Screening (Visit 1), or lung trasplant history, or, as judged by the investigator, patient may have required a thoracotomy or other lung surgery during the study.
  • Known active tuberculosis.
  • History of intersticial lung or massive pulmonary thromboembolic disease.
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  • History of bronchiectasis secondary to respiratory diseasesother 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), neurological, musculoskeletal, endocrine, metabolic, psychiatric, and major physical impairment) that, in the opinion of the investigator, could have placed the patient at risk for participation in the study, 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 oedema and/or cardiac arrhythmia.
  • History of cancer (within 5 years prior to Visit 1), except non-metastatic skin cancer and non-melanoma.
  • Patients who cannot perform spirometry manoeuvres or tolerate plethysmography.
  • Contraindications to the use of metformin: allergy to the drug, advanced renal failure (CKD stage 3 and above), patients 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Alberto Labiano Tabar contact

+34 848 42 32 36

alberto.labiano.tabar@navarra.es

About this study

Prospective, multicentre, double-blind, placebo-controlled, randomised, prospective clinical trial comparing the effect of metformin 850 mg twice daily with placebo in COPD patients with evidence of emphysema (by CT scan or reduced DLCO) who are known to have a rapid decrease in FEV1.

Main objective:

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

Participants will take metformin (850mg) or placebo twice daily for 3 years.

Conditions
COPD
Being tested
Metformin 850Mg Tab, Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin 850Mg TabDrug

    Tolerance phase dose: 850mg/24h for 2 weeks. Treatment dose: 1700 mg twice daily.

  • PlaceboOther

    Tolerance phase dose: One tablet/24h for 2 weeks. Treatment dose: Two tablets twice daily.

Study groups in NCT06999343
Study groupRoleWhat they receive
Experimental treatmentExperimentalExperimental treatment: Metformin Tolerance phase dose: 850mg/24h for 2 weeks. Treatment dose: 1700mg twice daily. Pharmaceutical form: 850 mg oral tablet. Duration of treatment: Treatment will last for 3 years.
Receives: Drug: Metformin 850Mg Tab
Control treatmentPlacebo comparatorControl treatment: Placebo Tolerance phase dose: One tablet/24h for 2 weeks. Treatment dose: Two tablets twice a day. Pharmaceutical form: Tablets with the same appearance as metformin tablets. Duration of treatment: Treatment will last for 3 years.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forced expiratory volume in the first second (FEV1)

    The amount of air expelled during the first second of a maximal expiration, performed after a maximal inspiration.

    Measured: At inclusion and at 3-years follow-up

  2. Carbon monoxide diffusion test (DLCO)

    Pulmonary function test, in which the diffusion of gases through the pulmonary alveoli into the blood is studied.

    Measured: At inclusion and at 3-years follow-up

Secondary outcomes (19)

  1. Age

    Years

    Measured: Baseline

  2. Sex at birth

    Male/Female

    Measured: Baseline

  3. Height

    Centimetres

    Measured: Baseline

  4. Weight

    Kg

    Measured: Baseline and at 1 year, 2 years and 3 years

  5. Smoking

    Cigarette packs/year

    Measured: Baseline

  6. The percentage of lung volume with emphysema measured on a chest CT scan.

    Measured: At inclusion and at 3-years follow-up

  7. 6-minute walk distance (6MWT)

    Metres in 6 minutes

    Measured: Baseline and at 1 year, 2 years and 3 years

  8. Grip strength with dynamometer

    Kg

    Measured: Baseline and at 1 year, 2 years and 3 years

  9. BODE Index

    The BODE index will result in a score of zero to ten dependent upon FEV1, body-mass index, the distance walked in six minutes, and the modified MRC dyspnea scale where 0 is the best state of health and 10 is the worst.

    Measured: Baseline and month 6, 12, 18, 24, 30 and 36

  10. Dyspnoea

    1, 2, 3, 4 or 5 grades where dyspnoea grade 1 is the best state of health and grade 5 is the worst state of health

    Measured: Baseline and at 1 year, 2 years and 3 years

  11. Major cardiovascular events

    Select from a list (Myocardial infarction/new angina/stroke) if any of these events happen.

    Measured: Month 6, 12, 18, 24, 30 and 36

  12. Cancer events

    Solid cancers Yes/No

    Measured: Month 6, 12, 18, 24, 30 and 36

  13. Renal dysfunction (microalbuminuria)

    mg/g

    Measured: Month 6, 12, 18, 24, 30 and 36

  14. Concomitant treatment

    EPOC concomitant treatment

    Measured: Month 6, 12, 18, 24, 30 and 36

  15. Exacerbations

    YES/NO

    Measured: Month 6, 12, 18, 24, 30 and 36

  16. Emergency room visits

    YES/NO

    Measured: Month 6, 12, 18, 24, 30 and 36

  17. Hospitalisations

    YES/NO

    Measured: Month 6, 12, 18, 24, 30 and 36

  18. Intubation

    YES/NO

    Measured: Month 6, 12, 18, 24, 30 and 36

  19. Obstruction

    YES/NO

    Measured: Month 6, 12, 18, 24, 30 and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 May 2029 (estimated)
  4. Study completion1 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06999343
Sponsor's protocol ID
AMICO
Acronym
AMICO
Status last verified
May 2025
First submitted
15 May 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin 850Mg Tab in people with COPD, run by Fundación Instituto de Investigación Sanitaria de Navarra.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alberto Labiano Tabar (+34 848 42 32 36, alberto.labiano.tabar@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced expiratory volume in the first second (FEV1) (time frame: At inclusion and at 3-years follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06999343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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