A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH.
Reason given: AstraZeneca have decided to not move forward with the development of the compound.
Key facts
- Where
- Atlanta, Chandler, Hialeah, Houston, Montclair, Morehead City, Port Orange, and San Antonio, United StatesSee the 8 sites
- Phase
- Phase 1
Where in United States
- AtlantaAtlanta, United StatesNo longer taking part
- ChandlerChandler, United StatesNo longer taking part
- HialeahHialeah, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- MontclairMontclair, United StatesNo longer taking part
- Morehead CityMorehead City, United StatesNo longer taking part
- Port OrangePort Orange, United StatesNo longer taking part
- San AntonioSan Antonio, United StatesNo longer taking part
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT05864391
- Record updated
- 20 July 2025
- Original description
The purpose of this study is to measure the safety, tolerability, and PK (measurement of drug activity in the body over time) of AZD7503 injected subcutaneously, and compared to placebo, in participants with suspected NASH, a type of liver disease.Read full original descriptionShow less
A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Ascending Dose Administration to Patients With Suspected Non-cirrhotic Non-alcoholic Steatohepatitis (NASH)
The purpose of this study is to measure the safety, tolerability, and PK (measurement of drug activity in the body over time) of AZD7503 injected subcutaneously, and compared to placebo, in participants with suspected NASH, a type of liver disease.
Inclusion: Biopsy-confirmed NASH diagnosis with CRN score of fibrosis stage of F1 to F3 within the previous 12 months prior to screening or history of fatty liver disease by imaging plus clinical suspicion of NASH based on history of type 2 DM for at least 5 years or overweight/obesity with BMI 25 to 40 kg/m\^2 with 2 additional metabolic syndrome components; Males and females of non-child bearing potential; Willing to provide written informed consent and comply with study requirements.
Exclusion: Changes in concomitant medication within 1 month of screening; Received another investigational drug within 90 days of administration of study intervention in this study; Has received any chemical entity or investigational drug targeting HSD17B13 (eg, ARO-HSD or ALN-HSD); Evidence of any clinical important condition which in the investigator opinion makes it undesirable for the participant to participate in the study; Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention; History of liver transplant or presence or history of hepatic disease other than NASH or histological or imaging evidence of cirrhosis; Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV)virus, seropositive for Hepatitis C virus (HCV); History of excessive alcohol consumption; Suspected history of illicit drug abuse; Clinically important abnormalities in urine and blood laboratory results; Uncontrolled high blood pressure; Any clinically important abnormalities in ECG.