359 Participants NeededMy employer runs this trial

AZD8965 for Pulmonary Fibrosis

(ARGiNAUT Trial)

Recruiting at 164 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AstraZeneca
Must be taking: Antifibrotics
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD8965 for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that makes breathing difficult. The study will evaluate the safety and effectiveness of different doses of AZD8965 compared to a placebo (a substance with no active medication). Participants may be taking other IPF medications or none at all. This trial might suit someone diagnosed with IPF who is either on stable medication or not taking any IPF treatment. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in IPF treatment.

Is there any evidence suggesting that AZD8965 is likely to be safe for humans?

Research has shown that AZD8965 has undergone safety testing in several studies. In trials involving 1,299 patients with idiopathic pulmonary fibrosis—a lung disease that causes scarring and makes breathing difficult—the treatment was generally well-tolerated, with most participants experiencing no serious side effects.

Another study tested various doses of AZD8965 in healthy individuals and found the treatment safe across different dose levels. While some side effects occurred, they were not serious for most participants.

In summary, data indicates that AZD8965 has been tested in many individuals and is considered safe. However, like any treatment, some side effects may occur.12345

Why do researchers think this study treatment might be promising for pulmonary fibrosis?

AZD8965 is unique because it targets pulmonary fibrosis in a way that existing treatments, such as antifibrotic medications like pirfenidone and nintedanib, do not. While standard treatments slow disease progression by inhibiting fibrosis, AZD8965 is designed to specifically target and modulate the underlying pathways involved in the fibrotic process. Researchers are excited about the potential for AZD8965 to offer more effective management of pulmonary fibrosis by addressing its root causes, potentially leading to better patient outcomes. Additionally, the trial includes various dosing levels, which allows researchers to fine-tune the optimal dose for maximum efficacy with minimal side effects.

What evidence suggests that AZD8965 might be an effective treatment for pulmonary fibrosis?

Research has shown that AZD8965 may help treat idiopathic pulmonary fibrosis (IPF). In studies with mice, AZD8965 significantly reduced harmful substances and collagen buildup in the lungs, which are major issues in IPF. Earlier studies with humans found that AZD8965 is safe and well-tolerated. Similar drugs, such as nintedanib and pirfenidone, have effectively slowed the decline of lung function in IPF patients. These findings suggest that AZD8965 could help manage IPF by reducing lung damage and preserving lung function.13678

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with idiopathic pulmonary fibrosis (IPF), whether or not they are already taking approved antifibrotic medications. Participants must meet specific health requirements set by the study team.

Inclusion Criteria

I have IPF and am either on stable antifibrotic therapy or not receiving standard treatment.
FVC ≥ 45% predicted of normal
DLCO corrected for hemoglobin ≥ 25% predicted of normal
See 2 more

Exclusion Criteria

The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan
I am currently experiencing a sudden worsening of my lung disease (IPF).
I have a lung infection that needs treatment.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three doses of AZD8965 or placebo for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • AZD8965

Trial Overview

The study tests three different doses of a new drug, AZD8965, against a placebo to see how well it works and how safe it is in people with IPF. Some participants may continue their current antifibrotic treatments during the trial.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD8965 medium doseExperimental Treatment1 Intervention
Group II: AZD8965 low doseExperimental Treatment1 Intervention
Group III: AZD8965 high doseExperimental Treatment1 Intervention
Group IV: Placebo for AZD8965Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

NCT06502379 | A Single and Multiple Ascending Dose ...

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy ...

Real-World Clinical Efficacy of Antifibrotic Agents for Idiopathic ...

The antifibrotic drugs, nintedanib and pirfenidone, inhibit the decline in forced vital capacity in patients with idiopathic pulmonary fibrosis (IPF).

August 2025 clinical trial highlights

Phase 2a idiopathic pulmonary fibrosis (IPF) study's positive results. In June 2025, Insilico Medicine announced the positive results of its ...

AZD8965 / AstraZeneca

Arginase inhibitor AZD8965: A novel therapeutic approach for idiopathic pulmonary fibrosis (ERS 2025) - "Moreover, in two Bleomycin-induced in- vivo mouse ...

Adverse side-effects of antifibrotic drugs and outcome of ...

Safety and survival data in patients with idiopathic pulmonary fibrosis treated with nintedanib: pooled data from six clinical trials. BMJ ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26835133/

integrated analysis of cumulative data from 5 clinical trials

Conclusions: A comprehensive analysis of safety outcomes in a large and well-defined cohort of 1299 patients with IPF who were followed ...

Idiopathic Pulmonary Fibrosis Clinical Research Trials

A Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD8965 in Healthy Participants (Including ...

A Phase IIb Study to Evaluate AZD8965 in... | Clinical Trial

This Phase IIb study aims to evaluate the efficacy, safety, and tolerability of 3 doses of AZD8965 treatment compared to placebo...