A study to investigate the effect of AZD6793 in participants with moderate to very severe chronic obstructive pulmonary disease - PRESTO

Study identifier:D7860C00006

ClinicalTrials.gov identifier:NCT07082738

EudraCT identifier:N/A

CTIS identifier:2025-520473-40-00

Recruiting

Official Title

A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2

Healthy volunteers

Study drug

AZD6793

Sex

All

Estimated Enrollment

1160

Study type

Interventional

Age

40 Years - n/a

Date

Study Start Date: 27 Jun 2025

Estimated Primary Completion Date: 05 Nov 2027

Estimated Study Completion Date: 05 Nov 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

* Participant must be ≥40 years of age at the time of signing the informed consent.
* Documented primary diagnosis of moderate to very severe 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 remain exacerbation free at Visit 3 (randomisation).
* Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).

Exclusion Criteria

* 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.

Sort by status

No locations available

Arms	Assigned Interventions
Experimental: Dose 1 of AZD6793 Approximately 290 participants will be randomized to receive Dose 1 of AZD6793	Drug: AZD6793 Oral dosage Other Name: N/A
Experimental: Dose 2 of AZD6793 Approximately 290 participants will be randomized to receive Dose 2 of AZD6793	Drug: AZD6793 Oral dosage Other Name: N/A
Experimental: Dose 3 of AZD6793 Approximately 290 participants will be randomized to receive Dose 3 of AZD6793	Drug: AZD6793 Oral dosage Other Name: N/A
Placebo Comparator: Matching Placebo Approximately 290 participants will be randomized to receive Matching Placebo	Other: Placebo Oral dosage Other Name: N/A

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Dave Singh

Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom