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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Biopsies, Ultrasound, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study participants will be followed for 12 months with assessments performed at screening, baseline, 6 months, and 12 months."
  • "The primary objective is to determine the effect of GLP-1 receptor agonist therapy on skeletal muscle function and physiology over 12 months."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 12-month study tests whether tirzepatide can improve muscle health and lung function in adults with COPD, a long-term lung disease that makes breathing hard. It is for adults ages 40–80 who are overweight or obese. The study also looks at body fat, inflammation, physical ability, and side effects.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 40–80 years old.
  • You have COPD confirmed by a breathing test after using medicine that opens your airways (FEV₁/FVC below 0.70).
  • Your COPD is GOLD stage 1–3, with a breathing test result called FEV₁ above 30% of the expected value.
  • You used to smoke and have smoked at least 10 pack-years, such as 1 pack a day for 10 years.
  • Your BMI, a weight measure based on height, is 30–40; or it is at least 27 with a weight-related health problem, such as high blood pressure or prediabetes.
  • You can and agree to sign a form giving permission to join.
  • You can follow study steps and attend follow-up visits.

Who can't join

  • You have type 2 diabetes with HbA1c, a blood sugar measure, above 6.5%; serious diabetes-related eye damage; or you take a diabetes drug called a DPP-4 inhibitor.
  • You are pregnant or breastfeeding.
  • You have a blood-clotting problem, with INR above 1.4 or a platelet count below 80,000/μL.
  • You have active cancer; a personal or family history of medullary thyroid cancer; or MEN2, a condition that can cause tumors in hormone-making glands.
  • Within 6 weeks of joining, you used medicines that strongly affect muscle protein, such as oral steroids, tamoxifen, high-dose estrogen, or testosterone.
  • You are allergic to tirzepatide or its ingredients, or cannot safely take it; have had pancreatitis (swelling of the pancreas); or have serious digestive, kidney, or gallbladder disease.
  • You had a COPD flare-up within 60 days before joining, or took part in a lung rehabilitation program within 2 weeks before joining.
  • The study team believes a medical, mental health, or social issue could make joining unsafe or keep you from following study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

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