Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations

NCT07275359 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: Pro001164161K76AG095138-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety and tolerability of Metformin and how it changes blood markers associated with aging in persons who have chronic obstructive pulmonary disease (COPD) who do not have diabetes.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD Exacerbation; COPD

Outcome Measures

Primary Outcomes (4)

• Determine feasibility of metformin administration in older persons with COPD without diabetes

  Enroll and retain ≥ 30 (66%) participants through 6 months study period

  6 months

• Determine acceptability of metformin administration in older persons with COPD without diabetes

  ≥70% completion of daily symptom diaries \& weekly adherence logs

  6 months

• Determine safety of metformin administration in older persons with COPD without diabetes

  ≥90% of the blood glucose levels, renal and hepatic function will be within normal limits\*; All lactate levels will be normal

  6 months

• Determine tolerability of metformin administration in older persons with COPD without diabetes

  Adverse events and Serious adverse events

  6 months

Study Arms (1)

Metformin

EXPERIMENTAL

Metformin in COPD patients without diabetes

Drug: Metformin

Interventions

Metformin DRUG

All enrolled participants will receive open-label Metformin for a treatment period of 6 months.

Metformin

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 and older
• History of COPD defined by spirometry demonstrating FEV1/FVC \< 70%
• or more tobacco pack year history
• History of frequent exacerbations defined as: 1 severe (i.e., COPD hospitalization) or 2 moderate (i.e., outpatient treated exacerbations) in the previous 12 months

You may not qualify if:

• Diabetes or actively being treated with metformin
• Metformin allergy
• History of lactic acidosis not explained by acute, severe illness
• History of low vitamin B12 levels and unwilling to begin standard of care treatment for low vitamin B12 levels
• Hepatic impairment defined as history of cirrhosis or abnormal liver function tests (e.g., alanine transaminase (ALT): 7-55 units per liter (U/L), aspartate transaminase (AST): 8-48 U/L, alkaline phosphatase (ALP): 40-129 U/L, or bilirubin: 0.1-1.2 milligrams per deciliter (mg/dL))
• Renal impairment defined as eGFR \< 60 mL/min/1.73m2
• Cognitive impairment
• Dementia
• Heart failure with reduced ejection fraction \< 50%
• Alcohol use disorder
• Disability preventing in-person visits
• Persons with an unstable medical condition (including but not limited to unstable angina, acute heart failure exacerbation, acute neurological symptoms) or COPD exacerbation within 30 days prior to enrollment will be excluded
• Active treatment with Carbonic Anhydrase Inhibitors including but not limited to topiramate, zonisamide, acetazolamide, diclofenamide

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke Asthma, Allergy, and Airway Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Christopher Mosher, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Mosher, MD

CONTACT

(919) 684-8111; christopher.mosher@duke.edu

Jessica Shier

CONTACT

(919) 684-9139; jessica.shier@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive open-label Metformin

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 2, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)