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

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What is this study about?

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.

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 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 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 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 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 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Children’s Health Medical Center EOOD Sofia Bulgaria
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Koranyi National Institute For Pulmonology Budapest Hungary
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Lungenpraxis – Praxisgemeinschaft Witten Witten Germany

Other Sites

Site Name City Country Status
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR Marburg Germany
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Semmelweis University Budapest Hungary
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Uufyrrwqll Malxjbhbfhfw Hjqxsosk Fnh Aifyzb Tikljning Stgki Gqsqbv Elc Plovdiv Bulgaria
Dwxidpjwvbc Avi Cptblqoczpbi Cduqfl Cyyqsq Lejh Sofia Bulgaria
Llstc Glxkklv Hzcdanhg Od Aoctpi Athens Greece
Movsoxj Cafsvd Pxozcfkghtb Llet Sofia Bulgaria
Ultculfxqx Gqhpfvs Hnjsuxrv Ot Iglnxekx Ioannina Greece
Hvhwrmyf Viht dtrbwjdh Barcelona Spain
Msrnydn Cfnwey Hnqhke Rpgh Ldxc Ruse Bulgaria
Ftrqrplzra Iqfut Pbwavypsber Sgf Mbfzag Pavia Italy
Hbzypjlh Czgrqj Dh Bwzrmzebj Barcelona Spain
Pwrhyhsgwybwzjqtrxgxz Mqkooxl Marburg Germany
Awhcrrm Ohqsqugosrn Uoofgyzadbmmb Saxrnv Siena Italy
Crfmcu Hvegjejsczh Rwwrdtdn Umgxrzckfhixi Dd Tmshz Tours France
Cpdncw Hfjyalacvkn Ueaeibvekonfz Dm Mqsauyxhtsc Montpellier France
Ajqhwvw Oxmjeecbdqf Urqcvbpmdarcg Cfypyykqxzyk Dmlkg Sfcgln E Dnqjc Sotoytm Dt Tjlwhe Turin Italy
Grnilrw Ulbyargemg Hrgufegj Og Putttl Patras Greece
Jruzckxtguukhpzshqkiszexpw Gbpedrr Giessen Germany
Mpjmqio Cufhvr &knhhmp Uqffgalncp Ov Funssfkk Freiburg Im Breisgau Germany
Aaofqrw Orksiqjeyde Uamnlalktnpbv Ochnchoh Rkzczeo Foggia Italy
Llvqrhysczww Hhtpo Dqgbqitge Glanjhmjuzlydoldvjvoxpaifbowf Gplm Hemer Germany
Kuxpkzqn dbp Uhqjuovryfbp Mongjfvs Auh Munich Germany
Ufzcjcvyzxxd Lbumkey Leipzig Germany
Cntrub Hpjdvumsquc Ubsrkbnkgmqal Du Rrhxuu Rennes France
Taowdcasbdfi Hadwwubqye gokop Heidelberg Germany
Utepvggfnc Mckkovy Cmkqaf Hmivckfqrtudrmmlu Hamburg Germany
Rkdksw Bhqcb Kbrwzngkiny Giag Stuttgart Germany
Uydtijeqdlmnexzutejly Sswsaefjgspvyfezlm Asz Kiel Germany
Kxjzppuu Ricqtn Hxzdozwr Glci Hanover Germany
Hguhaabj Ubjwlmprqegcs Dm Ld Puigveld Madrid Spain
Ccumwc Hpfjzbdvllm Rrgaiyvu Dojewoppuduzpj Angers France
Grglsv Nnbtndzrzr Tucxhoerxcwyw Gwqilp Prwytaccxgud Thessaloniki Greece
Pkcxnszqxovcvaiyrf Wuppertal Germany
Uojqmsetiv Gkylchg Hwgxrqqp Oz Hvctiygsn Heraklion Greece
Fuvwiprfvs Itqmt Shs Ghnetzi Dqd Tmqrhtx Monza Italy
Mqixhcy Cwwixx Pkqiyffdoo Emiv Haskovo Bulgaria
Hfnqxfvp Uwtpjpotkjrph Vmgqaa Dx Lk Vjiqeldo Malaga Spain
Ujrdvhqvci Gcyjtxq Hdmzpeig Akxjdcs Ghuweti Hlzhotua Oy Wshf Aexalr H Acup Vhfjauv Chaidari Greece
Osfuth Ubmtfwvqdr Hctldery Odense Denmark
Hkzsqk Hozbtjuf Herlev Denmark
Ggmpsgow Hwbxqcug Hellerup Denmark
Pmtholgzm Ifhyimzl Mpbbwkiy Msrmlpwigsmp Simru Wspaxjljbmop I Akcckeovmqzhg Warsaw Poland
Umaylidulchfl Snxsnsr Kmwfwxzve No 1 Il Njyiprma Brkgiifjctj Ujucmgrkzwpu Mvcfxokxof W Lsqza Scasp Lodz Poland
Cueedkc Myfhdzvu Obmrljjylq Mfga Sgy jb Bialystok Poland
Edct Cbovovc Umdnk Mbcwoxwlqk Eno Śddchqh Rzeszow Poland
Kibkhmehk Sxiuuih Sfwvikfgmeuzjbl ix Jptg Psmzh Id Cracow Poland
Uhvakcubxx Of Dncrpcbr Debrecen Hungary
Tuxkdgerlomxvygln Tsxixpironhoc Torokbalint Hungary
Arjzxbcox Uqz Amsterdam The Netherlands
Rbwsht Mscfgsdyxmx Aarhus Denmark
Akhufuo Uetxh Srfhpbvah Lenauv Dgllq Ryjdfdp Faenza Italy
Cjmrpu Hefqfrzlcmg Ljzi Sue Pierre Benite France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
15.06.2026
Denmark Denmark
Recruiting
15.06.2026
France France
Not yet recruiting
15.06.2026
Germany Germany
Recruiting
15.06.2026
Greece Greece
Not yet recruiting
15.06.2026
Hungary Hungary
Not yet recruiting
15.06.2026
Italy Italy
Not yet recruiting
15.06.2026
Poland Poland
Recruiting
15.06.2026
Spain Spain
Not recruiting
15.06.2026
The Netherlands The Netherlands
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.

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 ID:
2025-525016-41-00
Protocol code:
D6960C00005 ARGiNAUT
Trial Phase:
Therapeutic exploratory (Phase II)

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