The study focuses on people with Idiopathic Pulmonary Fibrosis, a rare condition in which scar tissue forms in the lungs and makes breathing progressively harder. The investigational medication being examined is AZD8965, an oral tablet taken by mouth, while another group will receive a placebo that looks the same but does not contain the active drug.
The purpose of the trial is to determine whether AZD8965 can reduce the loss of lung function compared with placebo, using the change in FVC (forced vital capacity, the amount of air exhaled forcefully after a deep breath) as the main measure over about 24 weeks. Participants will be screened, then randomly assigned to receive either the study drug or placebo for a six‑month period, with regular clinic visits for safety checks, blood samples, and simple breathing tests. Throughout the study, any side effects and overall health will be closely monitored.
1baseline visit and assessments
you attend the first study visit after joining the trial. during this visit, staff confirm that you meet the study criteria and collect baseline information.
baseline measurements include a lung function test called forced vital capacity (fvc), vital signs, blood and urine laboratory tests, and an electrocardiogram (ecg) to record heart activity.
2randomization and start of study medication
after the baseline visit, you are randomly assigned to receive either azd8965 or a placebo. both are provided as a film coated tablet for oral use.
the tablet contains 00 mg of the study drug (or no active substance for the placebo) and is taken as directed by study staff, typically once each day.
the treatment period is planned to continue for 24 weeks.
3ongoing treatment and periodic safety checks
you continue to take the assigned tablet daily for the duration of the study.
throughout the 24‑week period, you attend regular study visits where staff check your vital signs, repeat laboratory tests, and monitor for any side effects.
lung function (fvc) may be measured at several visits to track changes over time.
4final assessment at week 24
at the end of week 24, you undergo a final set of evaluations.
these include a repeat forced vital capacity (fvc) measurement, blood sampling to determine azd8965 plasma concentrations (if you received the active drug), and a full safety assessment covering vital signs, laboratory results, and any reported adverse events.
5study completion
after the final assessment, the study medication is stopped and you are no longer required to attend further study visits unless a follow‑up is arranged by the study team.
Who Can Join the Study?
Age 40 years or older.
A diagnosis of idiopathic pulmonary fibrosis (a rare lung condition that causes scarring of the lung tissue).
Either taking approved antifibrotic therapies (medicines that slow lung scarring) at a stable dose, or not taking those standard medicines.
A lung function measurement called forced vital capacity (FVC) must be at least 45% of the value expected for a healthy person of the same age, sex, and size.
A test of how well the lungs transfer oxygen, called diffusing capacity of the lung for carbon monoxide (DLCO), adjusted for hemoglobin, must be at least 25% of the normal predicted value.
Who Cannot Join the Study?
Having any interstitial lung disease (ILD) that is not idiopathic pulmonary fibrosis (IPF). ILD means a group of lung disorders that cause scarring, while IPF is a specific type of scarring lung disease.
Having more emphysema (damage that destroys the tiny air sacs in the lungs) than fibrotic changes (scar tissue) on a detailed chest scan called a high‑resolution CT (HRCT). This means the lung damage from emphysema is greater than the scar tissue.
Experiencing a sudden worsening, called an acute exacerbation, of IPF. This is a rapid decline in lung function and symptoms.
Having a lower respiratory tract infection (an infection in the lungs or airways) that requires treatment.
Having recent serious heart problems such as acute coronary syndrome, which includes a heart attack (acute myocardial infarction) or unstable chest pain (unstable angina), or having needed procedures like a balloon opening of arteries (Percutaneous Coronary Intervention) or heart‑bypass surgery (Coronary Artery Bypass Grafting).
Having heart failure, meaning the heart cannot pump blood effectively.
Having a history of any organ transplant or being likely to need a lung transplantation in the future.
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Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Bulgaria
Not yet recruiting
15.06.2026
Denmark
Not yet recruiting
15.06.2026
France
Not yet recruiting
15.06.2026
Germany
Not yet recruiting
15.06.2026
Greece
Not yet recruiting
15.06.2026
Hungary
Not yet recruiting
15.06.2026
Italy
Not yet recruiting
15.06.2026
Poland
Not yet recruiting
15.06.2026
Spain
Not yet recruiting
15.06.2026
The Netherlands
Not yet recruiting
15.06.2026
Trial locations
AZD8965 is an experimental oral medication taken as a film‑coated tablet. In this study it is being tested to see if it can help people with idiopathic pulmonary fibrosis (IPF) breathe better by improving the amount of air their lungs can hold. The drug is given to participants for several weeks, and researchers will compare changes in lung capacity with those who receive a placebo to determine if AZD8965 is safe and works well for this condition.
Idiopathic Pulmonary Fibrosis – A chronic lung condition in which scar tissue gradually replaces normal lung tissue, making the lungs stiff. The scarring reduces the ability of the lungs to expand and contract during breathing. Over time, this leads to a steady decline in lung capacity and increasingly shortness of breath. The disease typically progresses slowly but continuously, affecting daily activities.
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Bulgaria 
Denmark 
France 
Germany 
Greece 
Hungary 
Italy 
Poland 
Spain 
The Netherlands 