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Phase IIb Study of AZD8965 versus Placebo in Adults with Idiopathic Pulmonary Fibrosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline 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.

  2. Step 2

    Randomization 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.

  3. Step 3

    Ongoing 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.

  4. Step 4

    Final 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.

  5. Step 5

    Study 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 trial?

5 criteria

  • 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 trial?

7 criteria

  • 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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Investigated drugs

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.

What is already known about the treatment

AZD8965 - AZD8965 is taken by mouth as a film‑coated tablet. It is currently an investigational drug being studied in a Phase IIb trial for idiopathic pulmonary fibrosis, a rare lung disease that causes scarring. The medication works by blocking endothelin receptors, which helps to lower the signals that lead to tissue stiffening and fibrosis. It belongs to the class of oral endothelin receptor antagonists.

Investigated diseases

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.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-525016-41-00Protocol codeD6960C00005 ARGiNAUTEstimated enrolment360 patientsSponsorAstraZeneca AB

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