TerminatedPhase 1

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH.

Stopped: AstraZeneca have decided to not move forward with the development of the compound.

United States40 participantsStarted 2023-03-31

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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
✕. Uncontrolled high blood pressure
✕. Any clinically important abnormalities in ECG
✕. Suspected history of illicit drug abuse

What they're measuring

Number of subjects with adverse events (AEs)

Timeframe: Up to and including week 19 (from pre-screening to follow-up visit)

Number of subjects with serious adverse events (SAEs)

Timeframe: Up to and including week 18 (from pre-screening to final visit).

Trial details

NCT IDNCT05864391

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-20

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