GLIMR COPD

Not yet recruitingPhase 2

GLP-1 Agonists for Lung Function Improvement and Muscle Restoration in COPD

GLIMR COPD: GLP-1 Agonists for Lung Function Improvement and Muscle Restoration in COPD

Lead sponsor

The Cleveland Clinic

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Pulmonary Disease, Chronic Obstructive, Sarcopenia / muscle

Eligibility highlights

•BMI ≥27

Primary endpoint

•FEV1

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07747805

Org study IDIRB 25-1092

Secondary IDMandel MAG0024Cleveland Clinic Foundation

Timeline

Milestones

Study first posted2026-08-05actual

Last update posted2026-08-05actual

Study start2026-08-28estimated

Primary completion2028-08-15estimated

Study completion2029-08-15estimated

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweightPulmonary Disease, Chronic ObstructiveSarcopenia / muscle

Who can enroll

Minimum age40 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 40-80 years

•Diagnosis of chronic obstructive pulmonary disease (COPD) with post-bronchodilator FEV₁/FVC < 0.70

•GOLD stage 1-3 COPD (FEV₁ >30% predicted)

•Former smoker with a smoking history of at least 10 pack-years

•Body mass index (BMI) ≥27 kg/m² with at least one weight-related comorbidity (e.g., prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) or BMI 30-40 kg/m²

•Able and willing to provide written informed consent

•Able to comply with study procedures and follow-up visits

Exclusion criteria

•Type 2 diabetes mellitus (HbA1c > 6.5%)

•Pregnancy or breastfeeding

•Coagulopathy, defined as INR > 1.4 or platelet count <80,000/μL

•Active malignancy, including lung cancer

•Use of medications known to significantly alter muscle protein metabolism within 6 weeks of enrollment (e.g., oral corticosteroids, tamoxifen, high-dose estrogen, testosterone)

•Personal or family history of medullary thyroid carcinoma

•Multiple endocrine neoplasia syndrome type 2 (MEN2)

•Known hypersensitivity or contraindication to tirzepatide or its components

•History of pancreatitis

•Severe gastrointestinal disease that, in the opinion of the investigator, would increase risk from study participation

•Significant diabetic retinopathy

•Clinically significant renal impairment

•Clinically significant gallbladder disease

•Current treatment with a DPP-4 inhibitor

•COPD exacerbation within 60 days prior to enrollment

•Participation in pulmonary rehabilitation within 2 weeks prior to enrollment

•Any medical, psychiatric, or social condition that, in the opinion of the investigators, may interfere with study participation, adherence to study procedures, or participant safety

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

7 endpoints

Primary/protocol endpoint/low confidence

Change in FEV1

Time frame:12 months