A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

This Phase IIb dose-ranging study will evaluate the efficacy and safety of 2 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.

Key facts

Study ID

NCT07082738

Run by

AstraZeneca

People needed

987

Starts

2025-06-27

Expected to finish

2027-11-05

Last updated by the study team

2026-07-14

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be ≥40 years of age at the time of signing the informed consent.
• Documented primary diagnosis of COPD for at least 12 months prior to enrolment.
• Pre-BD FEV1/FVC < 0.7 at Visit 1 and pre- and post-BD FEV1/FVC < 0.7, and post-BD FEV1 ≥ 25% to < 80% of predicted normal at Visit 2.
• Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening.
• Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
• CAT score ≥ 10 at Visit 1.
• Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
• Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and are also exacerbation free for at least 4 weeks (28 days) prior to Visit 3 (randomisation).
• Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).

You may not qualify if…

• Clinically important pulmonary disease other than COPD (eg, asthma [current diagnosis per GINA or other accepted guidelines], active pulmonary infection, clinically significant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliary dyskinesia).
• Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
• Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment.
• Significant left heart failure.
• Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload.
• Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
• History of another underlying condition that predisposes the participant to infections.
• History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
• Abnormal laboratory findings.
• Participants with evidence of active liver disease and/or evidence of chronic liver disease.
• Participants with history of HIV infection or who test positive for HIV.
• History of lung volume reduction surgery.
• Current or history of malignancy within 5 years before the screening visit.

Where it is running

• Research Site — Ocala, Florida, United States (enrolling)
• Research Site — Sarasota, Florida, United States (enrolling)
• Research Site — Birmingham, Alabama, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — Ormond Beach, Florida, United States (enrolling)
• Research Site — Plantation, Florida, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — Newport Beach, California, United States (enrolling)
• Research Site — Norco, California, United States (enrolling)
• Research Site — Tustin, California, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — Brandon, Florida, United States (enrolling)
• Research Site — Cape Coral, Florida, United States (enrolling)
• Research Site — Clearwater, Florida, United States (enrolling)
• Research Site — Clearwater, Florida, United States (enrolling)
• Research Site — Los Angeles, California, United States (enrolling)
• Research Site — Lake City, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Miami Lakes, Florida, United States (enrolling)
• Research Site — Naples, Florida, United States (enrolling)
• Research Site — Tamarac, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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