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First human test of AZD4076 for fatty liver begins

NCT ID NCT02612662

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called AZD4076 in 40 healthy men to see if it is safe and how the body processes it. The drug is being developed for non-alcoholic steatohepatitis (NASH), a serious liver condition. This is an early, first-in-human trial, so it focused only on safety and drug levels, not on treating the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

40 people

The number who actually took part.

Started

Nov 2015

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures 2. Healthy male subjects aged 18 - 50 years with suitable veins for cannulation or repeated venipuncture 3. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive 4. Provision of signed, written and dated informed consent for optional genetic research Exclusion Criteria: 1. History or presence of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study 2. History or presence of hepatic or renal disease, or any other condition known to interfere with distribution, metabolism, or excretion of drugs 3. History or presence of significant neurological or psychiatric disease/mental illness (as judged by the investigator) 4. Suspicion of or known Gilbert's syndrome based on liver function tests 5. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of IMP 6. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator 7. Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) 8. Serum Creatinine greater than the ULN. 9. Platelet count outside the normal range. 10. AST, ALT, or GGT greater than the ULN. 11. Abnormal vital signs, after 10 minutes supine rest, defined as any of the following: * Systolic BP (SBP) \< 90mmHg or ≥ 140 mmHg * Diastolic BP (DBP) \< 50mmHg or ≥ 90 mmHg * Pulse \< 45 or \> 85 beats per minute (bpm) 12. Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy 13. Prolonged QTcF \> 450 ms or shortened QTcF \< 340 ms or family history of long QT syndrome 14. PR(PQ) interval shortening \< 120 ms (PR \> 110 ms but \< 120 ms is acceptable if there is no evidence of ventricular pre-excitation) 15. PR (PQ) interval prolongation (\> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree AV block, or AV dissociation 16. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS \> 110 ms. Subjects with QRS \> 110 ms but \< 115 ms are acceptable if there is no evidence of, for example, ventricular hypertrophy or pre-excitation 17. Known or suspected history of drug abuse, as judged by the investigator 18. Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening 19. History of alcohol abuse or excessive intake of alcohol, as judged by the investigator 20. Positive screen for drugs of abuse or cotinine (nicotine) at screening or admission to the unit or positive screen for alcohol on admission to the unit prior to the administration of IMP 21. History of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4076 tetracosasodium 22. Excessive intake of caffeine containing drinks or food (e.g., coffee, tea), as judged by the investigator 23. Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the administration of IMP 24. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the two weeks prior to the administration of IMP or longer if the medication has a long half-life 25. Plasma donation within one month of screening or any blood donation/blood loss \> 500 mL during the 3 months prior to screening 26. Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the administration of IMP in this study. The period of exclusion begins three months after the final dose or one month after the last visit whichever is the longest. Note: Subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded. 27. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order 28. Involvement of any Astra Zeneca, PAREXEL or study site employee or their close relatives 29. Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements 30. Subjects who are vegans or have medical dietary restrictions 31. Subjects who cannot communicate reliably with the investigator In addition, any of the following is regarded as a criterion for exclusion from the genetic research: 32. Previous bone marrow transplant 33. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Research Site

    Brooklyn, Maryland, 21225, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.