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NCT07747805Not 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

Source: ClinicalTrials.gov · Last updated 5 Aug 2026

Brief summary (registry, in English)

Chronic obstructive pulmonary disease (COPD) is associated with systemic inflammation, obesity-related metabolic dysfunction, skeletal muscle impairment, and progressive decline in lung function. While obesity has historically been viewed as protective in COPD, emerging evidence suggests that excess adiposity and adipokine dysregulation, particularly elevated leptin levels, contribute to chronic inflammation, impaired muscle function, and worse clinical outcomes. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have demonstrated anti-inflammatory, metabolic, and potential muscle-preserving effects beyond weight loss, making them promising therapeutic candidates for COPD. The GLIMR COPD study is a prospective, randomized, controlled pilot trial designed to evaluate the effects of tirzepatide on lung function, skeletal muscle health, inflammation, and body composition in overweight and obese adults with COPD. Thirty participants will be enrolled at the Cleveland Clinic COPD Center, including 20 participants receiving tirzepatide and 10 age- and sex-matched control participants. Study participants will be followed for 12 months with assessments performed at screening, baseline, 6 months, and 12 months. Tirzepatide-treated participants will undergo standard dose escalation to a maintenance dose of 2.4 mg weekly. The primary objective is to determine the effect of GLP-1 receptor agonist therapy on skeletal muscle function and physiology over 12 months. Secondary objectives include evaluating changes in body composition, systemic inflammation, adipokine signaling, immune function, pulmonary physiology, physical performance, and treatment tolerability. The study is built around three mechanistic aims. First, we will characterize the effects of GLP-1 therapy on systemic inflammation and immune dysregulation using longitudinal blood-based proteomic analyses and adipokine measurements, including leptin and adiponectin. Second, we will investigate the impact of GLP-1 therapy on skeletal muscle mitochondrial function and fatty acid oxidation using muscle biopsies obtained at baseline and 12 months, combined with high-resolution respirometry, transcriptomics, metabolomics, and proteomics. Third, we will assess changes in clinical outcomes including lung function, body composition, muscle strength, and physical performance. Participants will undergo comprehensive phenotyping that includes spirometry, respiratory muscle strength testing, six-minute walk testing, handgrip strength, sit-to-stand testing, body composition assessment, diaphragm ultrasound, and non-contrast CT imaging of the lungs and thighs. Blood samples will be collected for biomarker, proteomic, metabolomic, genomic, and immunologic analyses. Vastus lateralis muscle biopsies will be performed at baseline and study completion to evaluate mitochondrial bioenergetics and molecular pathways associated with muscle remodeling. Eligible participants will be adults aged 40-80 years with COPD, a smoking history of at least 10 pack-years, and overweight or obesity. Individuals with diabetes, active malignancy, recent COPD exacerbations, contraindications to tirzepatide, or conditions that could interfere with study participation will be excluded. This pilot study is designed to generate critical mechanistic and clinical data regarding the role of GLP-1 receptor agonists in COPD. Findings will help define the relationships among obesity, adipokine signaling, systemic inflammation, skeletal muscle dysfunction, and lung disease progression, while providing preliminary efficacy estimates to support the design of a future multicenter randomized clinical trial evaluating GLP-1 therapy as a novel treatment strategy for COPD.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
31 Jul 2026
Start date
28 Aug 2026
Primary completion date
15 Aug 2028
Lead sponsor
The Cleveland Clinic
Diseases
Obesity, COPD
NCT number
NCT07747805

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From 28 Aug 2026 to the primary completion date, 15 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Active malignancy, including lung cancer
  • 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
  • Clinically significant renal impairment
  • Clinically significant gallbladder disease
  • 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

Lab values

  • Type 2 diabetes mellitus (HbA1c \> 6.5%)
  • Coagulopathy, defined as INR \> 1.4 or platelet count \<80,000/μL

Other

  • Pregnancy or breastfeeding
  • Significant diabetic retinopathy

Who the study is looking for

  • 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

Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.