A Study of AZD6793 for Moderate to Very Severe COPD

This study is looking at a new oral medication called AZD6793 for people with moderate to very severe chronic obstructive pulmonary disease (COPD). It will compare two different doses of AZD6793 to a placebo (an inactive pill) to see how well they work and if they are safe. To join, you must be at least 40 years old and have a confirmed diagnosis of COPD for at least 12 months. The main goal is to see if AZD6793 can reduce the number of moderate or severe COPD flare-ups you experience over 24 weeks. The current status of this study is unclear, but it plans to enroll about 987 participants globally.

Study design
This is a Phase IIb, randomized, double-blind, placebo-controlled study involving approximately 970 participants who will be assigned to receive AZD6793 or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured from baseline up to 24 weeks.

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NCT07082738

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

Recruiting
PHASE2Ages 40+InterventionalTreatment
AstraZeneca
~987 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:AZD6793Placebo

At a glance

Recruiting sites
330 of 368 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualised rate of moderate or severe COPD exacerbations
Measured over From baseline up to 24 Weeks
Chronic Obstructive Pulmonary Disease (COPD)
368 sites across 56 states
Japan38
China30
Florida21
Germany20
Poland19
South Korea14
Texas12
Argentina11
  • Dave Singh, MD · PRINCIPAL_INVESTIGATOR · Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom
AstraZeneca Clinical Study Information Center
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Eligibility criteria

Inclusion

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).

Exclusion

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.
  • Annualised rate of moderate or severe COPD exacerbationsFrom baseline up to 24 Weeks

    The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo