AZD4831

DRUG11 trials

Sponsors

Astrazeneca AB, AstraZeneca

Conditions

"Non-Alcoholic Steatohepatatis (NASH) is the progressive form of Non-Alcoholic Fatty Liver Disease (NAFLD)with a prevalence of approximately 2% to 3% of the general population. Non-alcoholic steatohepatitis can lead to cirrhosis and its complicationsCardiovascular DiseaseHealthy VolunteersHeart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Preserved Ejection Fraction (HFpEF)NASH is frequently associated with a hyperinsulinemic or insulin resistant stateNon-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

Phase 1

A Study to Assess the Safety and Tolerability of Single and Multiple Doses of AZD4831 in Healthy Male Subjects

TerminatedNCT02712372

AstraZenecaCardiovascular Disease

Start: 2016-06-30End: 2016-10-31Updated: 2017-01-06

A Phase I, Safety Tolerability and Pharmacokinetics of AZD4831 to Treat Cardiovascular Disease

CompletedNCT03136991

AstraZenecaCardiovascular Disease

Start: 2017-05-15End: 2017-11-22Updated: 2020-01-18

A Study to Assess the Effect AZD4831 in Japanese and Chinese Healthy Volunteers

CompletedNCT04232345

AstraZenecaHeart Failure With Preserved Ejection Fraction (HFpEF)

Start: 2020-01-16End: 2021-03-11Updated: 2021-04-01

A Study to Assess the Pharmacokinetics (Uptake of Drugs by the Body), Safety and Tolerability of AZD4831 in Participants With Severe Renal Impairment and Healthy Volunteers

CompletedNCT04949438

AstraZenecaRenal Impairment

Start: 2022-01-21End: 2022-03-04Updated: 2022-04-05

Study to Assess the Effect of AZD4831 on the Pharmacokinetics (Drug Behavior in the Body) of Midazolam

CompletedNCT05052710

AstraZenecaHealthy Volunteers

Start: 2021-10-05End: 2021-11-29Updated: 2021-12-13

A Study to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole

CompletedNCT05236543

AstraZenecaHealthy Volunteers

Start: 2022-02-18End: 2022-08-12Updated: 2022-08-23

A Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD4831 in Fasted State in Healthy Volunteers.

CompletedNCT05457270

AstraZenecaHealthy Volunteers

Start: 2022-08-11End: 2022-10-17Updated: 2022-11-01

Phase 2

Safety and Tolerability Study of AZD4831 in Patients With Heart Failure.

TerminatedNCT03756285

AstraZenecaHeart Failure

Start: 2018-12-11End: 2020-05-07Updated: 2021-07-19

Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%

CompletedNCT04986202

AstraZenecaHeart Failure With Preserved Ejection Fraction

Start: 2021-06-30End: 2024-03-27Updated: 2025-08-27

A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacodynamics of AZD4831 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis

CompletedCTIS2022-500594-13-00

Astrazeneca ABand dyslipidemia. Pathophysiologically, and end stage liver disease. Non-alcoholic steatohepatitis is defined histologically as a multicomponent condition composed of hepatic steatosis, and hepatocyte ballooning in varying proportions. NASH differs from steatosis alone by the presence of hepatic cell inflammation and injury in response to lipotoxic intermediates that are accumulated and metabolized in the steatotic liver. NASH is closely associated with metabolic risk factors including obesity +6

Start: 2022-12-14End: 2024-04-04Target: 48Updated: 2023-08-01

A Study in Participants With Non-cirrhotic NASH With Fibrosis

CompletedNCT05638737

AstraZenecaNon-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

Start: 2022-10-26End: 2024-04-04Updated: 2025-07-09

Related Papers

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Pharmacokinetics and Tolerability of the Novel Myeloperoxidase Inhibitor Mitiperstat in Healthy Japanese and Chinese Volunteers

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